ARGX

Image source: The Motley Fool. Oct. 22, 2026 - Vice President of Corporate Affairs - Beth DelGiacco - Chief Executive Officer - Karen Massey - Chief Financial Officer - Karl Gubitz - Chief Commercialization Officer - Sandrine Piret-Gerard - Chief Medical Officer - Luc Truyen Operator: Good morning. My name is Ryan, and I will be your conference operator today. I would like to welcome everyone to the call. [Operator Instructions] Thank you. I'd like to introduce Beth DelGiacco, Vice President of Corporate Affairs. You may now begin your call. Beth DelGiacco: Thank you. A press release was issued earlier today with our third quarter 2026 financial results and business update. This can be found on our website, along with the presentation for today's webcast. Before we begin, I'd like to remind you that forward-looking statements may be presented during this call. These may include statements about our future expectations, clinical development, regulatory time lines, the potential success of our product candidates, financial projections and upcoming milestones. Actual results may differ materially from those indicated by these statements. Argenx is not under any obligation to update statements regarding the future or to conform those statements in relation to actual results unless required by law. I'm joined on the call today by Karen Massey, Chief Executive Officer; Karl Gubitz, Chief Financial Officer; and Sandrine Piret-Gerard, Chief Commercialization Officer. Luc Truyen, Chief Medical Officer, will be available during the Q&A. I'll now turn the call to Karen. Karen Massey: Thank you, Beth, and welcome, everyone. This has been another outstanding quarter for argenx. Nearly 5 years into launch, we're still early in realizing VYVGART's potential across MG and CIDP. And on the heels of positive Phase III ALKIVIA results, we're seeking to bring VYVGART into rheumatology for the first time with the goal of reaching an entirely new group of patients and prescribers. Beyond VYVGART, we're building what comes next for argenx. We're advancing empasiprubart towards its first Phase III readout in MMN. And we had positive Phase II results for FB102 in celiac disease, just months after the Forte acquisition, giving us another Phase III-ready program. Across our broader pipeline, we expect to have 10 molecules in clinical development by the end of this year. This progress reflects something fundamental about how we innovate at argenx. We pursue novel foundational biology that has the potential to make a meaningful difference across multiple diseases of high unmet need. This boldness often has us leading the way, shaping new markets like we have in MG and CIDP and exploring the boundaries of where a target can have the greatest impact for patients. That's how we're building the next chapter of argenx, expanding the opportunity for VYVGART while creating new pillars of growth alongside it. It's what gives us confidence in our ability to deliver on Vision 2030 and sustain growth beyond that. As we look ahead, 2027 will be an important year in the evolution of argenx with 5 potential launches across our portfolio. Together, they would mark significant progress towards Vision 2030. In MG, our ambition is for VYVGART to become the treatment of choice across the spectrum of disease. We have a PDUFA date early next year for pediatric MG, and our recent filing in ocular MG could extend VYVGART beyond generalized MG for the first time. In the second half of 2027, we also expect to introduce the VYVGART Hytrulo auto-injector, continuing to elevate the treatment experience across approved indications. Autoimmune myositis is positioned to be the next major area of growth for VYVGART. ALKIVIA further validated the role of autoantibodies in myositis, demonstrating consistent and clinically meaningful results in both IMNM and DM patients. IMNM is where we have the immediate opportunity and has the greatest unmet need. Patients lose their independence within months, and there are no approved treatments today. We will file an sBLA in IMNM by year-end, for which we have breakthrough therapy designation. We remain committed to securing a label for people living with DM. And based on the strength of the ALKIVIA data, we are moving with urgency to start an additional registrational study. Now let me turn to empasiprubart and MMN, where we are approaching the expected readout of the EMPASSION study in December. MMN is a serious autoimmune disease that affects 12,000 patients across our key markets. Today, patients depend on IVIg, often spending hours in the infusion chair and many still experience worsening symptoms over time. We believe empasiprubart has the potential to offer a differentiated treatment option, both in the outcomes it could deliver for patients and in reducing treatment burden. We have good reasons for this conviction. We believe C2 is the right point in the complement pathway to intervene above where the damage in MMN starts. And empasiprubart was engineered as a sweeping antibody to efficiently remove C2 and achieve sustained C2 suppression. The Phase II ARDA data gave us meaningful clinical evidence to support this C2 targeting approach. We saw improvements in grip strength and function together with a substantial reduction in the need for IVIg retreatment. With longer-term treatment, these improvements in grip strength were sustained through 64 weeks. We took those learnings into EMPASSION, our Phase III head-to-head study against IVIg. It's a bold choice to go directly against the current standard of care, but it's one that is grounded in what we know of the biology, the molecule and the ARDA data. The study asks a very practical question, can empasiprubart deliver efficacy comparable to IVIg while reducing the treatment burden? If the answer is yes, that will be meaningful for patients. MMN is only the beginning for empasiprubart. We believe C2 inhibition has the potential to address a broad range of complement-driven diseases, creating another opportunity to build a pipeline in a product. Beyond our FcRn portfolio and empasiprubart, our pipeline continues to advance and FB102 is the latest example of that progress. The positive Phase II results in celiac reinforced our belief in CD122 as a target and gives us another asset ready to advance into Phase III. FB102 has many of the characteristics we look for in a medicine, novel biology, the opportunity to be first-in-class in a disease that has seen little innovation and the potential to address multiple autoimmune diseases. Celiac is the most advanced opportunity and the consistency of the Phase II results across efficacy measures, including symptoms, together with this favorable safety profile, reinforced the potential we see in the molecule. In 2027, we plan to share more about how we will further unlock the broader pipeline and a product potential of FB102. More broadly, our pipeline is becoming both deeper and more mature. Adimanebart is advancing to Phase III in CMS. ARGX-121 is in Phase II in IgA nephropathy and additional first-in-class molecules are advancing across new mechanisms and disease areas. This breadth is important to our strategy, giving us multiple opportunities to deliver on Vision 2030 while building the foundation for sustainable growth beyond it. With that, I'll turn the call over to Karl. Karl Gubitz: Thank you, Karen. Next slide. I am pleased to review our third quarter 2026 financial results detailed in this morning's press release. Growth in the number of patients we serve continues to drive strong revenue performance, giving us the capacity to invest across our portfolio from a position of financial strength and with a clear focus on long-term value creation. Product net sales were $1.7 billion, representing growth of 54% year-over-year and 13% quarter-over-quarter. By region, product net sales were $1.5 billion in the U.S., $81 million in Japan, $158 million across the Rest of the World and $11 million from product supplied to Zai Lab in China. U.S. product net sales grew 16% quarter-over-quarter with net pricing broadly consistent with prior quarters. Gross to net deductions were 22%, in line with our expectations. In Japan, sales grew 47% year-over-year. The quarter-over-quarter comparison is impacted by the onetime benefit of approximately $25 million in the second quarter associated with a change in our distribution model. The markets in the Rest of the World grew 70% year-over-year, reflecting strong underlying demand. Next slide. Our expenses this quarter reflects both the addition of Forte and the growing opportunity across our portfolio. Total operating expenses were $1.3 billion. Combined R&D and SG&A expenses were $1.1 billion, an increase of 22% quarter-over-quarter. These expenses included $150 million of transaction-related costs associated with the Forte acquisition. Excluding the transaction-related costs, the increase is 5%. Operating profit was $486 million, representing an operating margin of 28%. Adjusted for the Forte transaction-related cost, this is 37%. Revenue growth continues to outpace expense growth, demonstrating the operating leverage in our business while supporting investment for future growth. Our year-to-date effective tax rate was 10%. We ended the quarter with $3.7 billion in cash, cash equivalents and current financial assets after paying a net $2.1 billion for the Forte acquisition. Turning to our full year investment plans. These have evolved since we discussed expenses earlier in the year. We now expect combined R&D and SG&A expenses of approximately $4 billion for 2026. The increased investments include the transaction-related cost of Forte, investment into FB102 following the acquisition, continued progress across our pipeline and investment in our commercial infrastructure following the positive ALKIVIA result. We are making these investments from a position of financial strength, supporting the opportunities emerging from 10 assets in the clinic across our portfolio. We will continue to prioritize these investments with discipline. Our capital allocation priorities remain clear: strengthen the VYVGART franchise, advance a diversified pipeline for future growth and maintain the financial flexibility to execute our strategy as we deliver on Vision 2030. I will now turn the call over to Sandrine. Sandrine Piret-Gerard: Thank you, Karl. It has been an incredible quarter with tremendous energy as we engage with HCPs and patients. And the feedback is remarkably consistent. VYVGART continues to set a high bar for what treatment can deliver, and we are seeing the impact it can have for patients. That impact is translating into impressive growth. This was among our strongest quarters of patient growth since launch. In MG, we are moving VYVGART into earlier lines of treatment, while our seronegative label expansion is lifting growth across all of MG. In CIDP, we continue to add new patients and new prescribers at a steady pace. As HCPs gain experience with VYVGART and see outcomes in their patients, the confidence grows, supporting continued adoption. Let me spend the next few slides discussing the drivers of performance in both MG and CIDP. In MG, our goal remains clear: to establish VYVGART as the treatment of choice for all MG patients. We aim to get there by broadening the label and reaching patients earlier in their treatment journey. Five months into the seronegative launch, we are off to a strong start. Seronegative was a key contributor of growth this quarter. Our Access teams have done an outstanding job securing coverage for approximately 96% of covered lives. And most payers have removed serotype testing from their VYVGART policies, making it simpler to prescribe VYVGART for gMG patients. Importantly, the launch is driving both breadth and depth. Approximately 10% of seronegative prescribers are new to VYVGART and growing physician experience in seronegative patients is driving increased prescribing in acetylcholine receptor antibody positive patients, creating a halo effect across MG. The biggest opportunity ahead is reaching patients earlier and the evidence keeps building. At MGFA, real-world data from more than 1,100 patients show that half of those who started VYVGART within a year of diagnosis reached minimal symptom expression. Potential label expansion into ocular and pediatric MG could further extend the opportunity to reach patients earlier. We have submitted supplemental BLA for both indications with a pediatric PDUFA date of February 2027. We are moving closer to a future where VYVGART may serve patients across the entire MG spectrum. In CIDP, we continue to see steady growth in new patients and prescribers quarter-over-quarter. More physicians are gaining experience with VYVGART. More patients are experiencing the difference treatment can make in their daily lives and the prefilled syringe is offering patients greater convenience and flexibility in how treatment is administered. I recently heard a patient story that captures exactly why our work matters. Gail is a woman whose CIDP had progressed to the point where she was receiving hospice care and was told that she was not expected to live more than a week. Her daughter had learned about VYVGART while she was in hospice care and asked Gail's HCP about it. After starting treatment, she returned to doing the things she loves, including using her hands to create artwork, and she even recently got her driver's license back. For Gail, regaining grip strength was more than just a clinical measure. It meant getting her life back. This is just one story that highlights the importance of reaching patients and family with information that can empower them to have meaningful conversations about treatment. Through ADHERE and ADHERE+, we have now followed patients for more than 5 years, building the most extensive long-term data set in CIDP. At AANEM, we showed that nearly 40% of patients who initially responded to VYVGART reached an INCAT score of 0 or 1 during the open-label extension, reflecting little to no functional disability. We also continue to see evidence that patients can benefit from VYVGART early in their disease journey as seen in our treatment-naïve data set. While our Phase IV switch study data support the feasibility of a 1-week transition from IVIg. Together, this data and growing real-world evidence continue to build confidence in VYVGART and support adoption across the CIDP community. Autoimmune myositis is where we plan to take the VYVGART playbook next, and IMNM is the perfect starting point. IMNM is one of the most urgent unmet needs as patients can rapidly decline from their initial symptoms to needing a wheelchair in 3 to 6 months. Despite the severity of the disease, the approximately 20,000 patients living with IMNM in the U.S. today have no approved treatment options. The combination of profound unmet need and its CIDP-like size makes IMNM a compelling growth opportunity for argenx starting in 2027. As we advance towards the sBLA filing, we are leveraging the same playbook that worked in MG and CIDP: disease education, deep physician engagement, strong patient support, broad access, evidence generation and best-in-class execution. We have been engaging with KOLs who treat autoimmune myositis and the feedback has been consistently strong. Patients need more safe and effective treatments, and we believe VYVGART's profile meets the mark. Our medical team, including MSLs, is already in place, payer conversations are underway, and we are expanding on sales team. We look forward to connecting with the rheumatology community at ACR in November, where the Phase III ALKIVIA results will be presented during an oral session. To conclude, 2027 could bring up to 5 launches in a single year in the U.S. Our teams are ready, and I could not be more excited about what is ahead. With that, let me turn the call back to Karen for closing remarks. Karen Massey: Thank you, Sandrine. Argenx continues to be defined by entrepreneurial science. We're developing medicines by pursuing bold biology, asking difficult scientific questions and challenging assumptions about what is possible for patients. There is so much to be proud of this year, and there is even more ahead as we approach 2027. From expanding the impact of VYVGART to advancing the next wave of innovation across our pipeline, we remain firmly on track towards Vision 2030. And with that, operator, we'll open the call for questions. Operator: [Operator Instructions] Our first question will come from Tazeen Ahmad with Bank of America. Daniel Giraldo Perez: This is Daniel on for Tazeen. Congrats on all the updates. I had a question on ALKIVIA. What additional data should we expect to see at the ACR presentation? And can you maybe comment a little more on the feedback you've been getting from physicians? And then as you think about the DM trial, what are going to be the key considerations there? Do you think you'll just need a bigger trial? Or is there something else that will need to be changed from what you did before? Karen Massey: Yes. Thanks for the question and the interest in DM. So yes, on the -- related to -- I'll start with your third question related to the DM trial. So we had the sBLA meeting recently, and it gave us the clarity that we were looking for. So as you call out, it confirmed actually the base case that we've also been planning for. So we've been planning in parallel and designing what we think a DM trial will look like. The teams are working on that. You'll understand that until we finalize that and get further down the path, we won't be public on what that will look like. But perhaps, Luc, you could share some of the considerations that the team has been looking at as we think about that potential DM trial. Luc Truyen: Yes. Thanks, Karen. And we will again use the argenx playbook because we have significant data in Phase II and III that we will build upon that will inform this next design to make it the most efficient possible and to speed the path to patients with DM. And as you asked for, the ALKIVIA results that will be presented at ACR as an oral late-breaker will contain a significant amount of data on the efficacy profile across IMNM and DM. Operator: Our next question will come from Derek Archila with Wells Fargo. Derek Archila: Congrats on the progress. I was just wondering if you could provide some color on how both MG and CIDP revenues are growing. Is it about the same rate quarter-over-quarter? And then ultimately, for that MG base business, how should we think about the impact on that current growth trajectory with ocular MG, pediatric MG and auto-injector launches in '27? Karen Massey: Yes. Derek, thanks for the question. I think it's incredible, isn't it that 5 years since launch, we continue to see momentum and sustained growth. And I think it just shows what that strategy of consistent and steady cadence of innovation coming to the market, how that can contribute to growth. But maybe, Sandrine, you can comment on the MG and CIDP dynamics in the quarter. Sandrine Piret-Gerard: Yes. Thank you, Karen. Thank you, Derek. So both indications have been growing really well. So we don't see a slowdown of CIDP or we don't see MG just being the driver of growth this quarter like the other quarters. So both continue to grow very nicely. As you mentioned, I mean, we have seen a great launch with seronegative. And one of your question is to say, what does it mean in terms of the trajectory, assuming we get approval for both pediatric MG and ocular MG. So we are very pleased about the seronegative launch because not only Access has been strong in removing some of the hurdle in terms of serotype testing that makes it very, very simple to prescribe. But what we have seen is the halo effect that seronegative MG has on the broader gMG population, both on the breadth of prescribers where we saw that 10% of the seronegative prescribers were completely new to VYVGART, but also on all the seropositive patients. And it's mostly driven by simplicity. If you put yourself in the shoes of a physician, you have a patient with gMG coming into your practice, it's very easy to just have to remember about VYVGART. You don't have to do the serotype testing. It's a one-stop shop. And what we believe is that this halo effect is probably going to also be seen and replicated for both pediatric MG and ocular MG, positioning VYVGART even earlier in the treatment paradigm and contributing to this halo effect. So we are very excited about that. And just to be honest, we were a bit surprised by the magnitude of that halo effect. We knew there would be some, but this confirms that it really has an impact beyond just the indication itself. It has a broader halo effect. Operator: Our next question will come from Victor Floch with BNPP. Victor Floch: Congratulations for another strong quarter. My question is for Karl, if I may. Karl, would you mind help us quantify the different moving parts behind the increase in your OpEx guidance this year? Is that fair to assume that only a small part of the increase comes from additional investment in your platform, while most of it is actually driven by the Forte acquisition cost, the OpEx related to Forte and the recently announced Phase III trials? And looking at next year, could you give us a sense of where OpEx could land? Is that fair to say there is now some headroom to consensus revenue expectation next year given that pediatric gMG, oMG, IMNM and potentially MMN could all start contributing by midyear at the latest? Karl Gubitz: Victor, thank you for the question. I need to start with what Sandrine said, it's the strength of the revenue, 19 quarters in a row, and it's that revenue growth, which allows us to invest from a position of strength. If you look at this quarter, operating expenses of $1.3 billion, SG&A and R&D in there of around $1.1 billion in that number is $150 million of the Forte acquisition cost. That's basically the only Forte cost in the quarter and drove higher expenses from Q2 to Q3. On a full year basis, sorry, $1.3 billion, of course, brings you to an operating margin of 28%. If you exclude the Forte transaction cost, operating margin is 37%. I think that's really important because it shows you that we continue to invest. However, we also continue to drive margin expansion. That's really important. Looking to the full year, we now put the number out there of around $4 billion. The increase to what -- the Street was previously expecting can basically be attributed to Forte, Forte being around half of it. That breaks down to the $150 million, which is already in Q3, plus call it another $50 million, which is the FB102 operating cost for the rest of the year as we plan to invest in that opportunity. The rest of course includes -- rest of the increase includes some commercial cost for Sandrine to -- following the successful ALKIVIA results as we're going to start to ramp up our IMNM and rheumatology capabilities. And the remainder of those costs in '26 is largely driven by having 10 assets in the clinic. A lot of that driven by CMC type of work as we need to get those -- to build those inventory and get that already. So that gets you to the $4 billion. If you compare it to 2025, that translates to a 45% increase year-over-year from '25 to '26. For '27, I think at JPMorgan, we'll provide a better guidance, but please do not assume another 45% increase into 2027. Clearly, the base is already lower and also we won't see the same jump. Think of about half of that 45% if you need something for your models now, but we'll give more guidance at JPMorgan. I think what's important is that we were going to invest in our opportunities and we will continue to provide operating leverage going forward. Thank you for the question. Operator: Our next question will come from Gavin Clark-Gartner with Evercore. Gavin Clark-Gartner: Just on EMPASSION for MMN, what is the non-inferiority margin that's specified in the study? And can you just remind us what your expectations for the IVIg arm performance are? Karen Massey: Gavin, thanks for the question. I'm really looking forward to the Phase III readout in December. This is potentially our second molecule and our next pillar of growth alongside VYVGART. So it's an important moment for us. And before we get into discussing the inferiority (sic) [ non-inferiority ] margins and all of those details, I think it's important that we take a step back and think about MMN and MMN patients. There's been no innovation in this space for decades actually. And I think it's important to say that even a placebo-controlled study would be groundbreaking for this market and for these patients. So the choice to go head-to-head, I think, is a bold one. I think we've set ourselves up for success with how we've designed the study. And obviously, we need to wait for the data to speak. But maybe, Luc, you could add some more color on how we thought about designing the head-to-head study. Luc Truyen: Yes. Yes. Thank you, Karen. And just we are not public on the actual margin, but I can clearly explain why we chose a non-inferiority design. This was based on the learnings from ARDA and thinking about how can we best define the potential of empasiprubart. So the head-to-head here against IVIg is based on the fact that in the Phase II, we largely avoided the need for IVIg in the active arm, whereas untreated patients in almost all cases needed IVIg. So the better to describe the effect is go straight to head-to-head. And we think that the performance of IVIg will be as we've seen historically, both in ARDA in external data, but we will even have a check on that within the study itself. So each patient can be on their cycles, 2 cycles of them before they get into the randomized part. So we will know very well what IVIg will do. Based on our data in hand, the expectation is we can match that. And there is always opportunity to show superiority, but the data will ultimately tell that story. Operator: Our next question will come from Akash Tewari with Jefferies. Akash Tewari: So how confident is your team that you can deliver on Vision 2030 post the Sjögren's miss and the DM update today? Our math suggests if you have consistent patient adds for CIDP and gMG, you'll approach around 40,000 patients on those 2 indications. But that would mean IMNM would represent the bulk of the additional patient adds you would have. Is that the right way to think about it that those 3 indications alone could push you past the 50,000 patient target? Karen Massey: Thanks for the question, Akash. I always like to talk about Vision 2030, and we're well on track, and I think I have strong conviction that we'll hit Vision 2030, and we have multiple paths to get there. So just to lay it out, as you said, the first part of Vision 2030 is 50,000 patients by the end of the decade. We've always said that the bulk of those patients will come from MG and CIDP, just given the timing of launch and the continued growth that we expect. And then obviously, the additional indications, IMNM also potentially if we get an MMN approval and any other approvals before 2030 will contribute, but the majority would be MG and CIDP. In terms of the other parts of Vision 2030 that are important for our future growth, 10 labeled indications, we're well on track with that and the 5 potential launches next year add obviously significantly towards that goal. So I'd say we're well on track for 10 labeled indications. And we want 5 molecules in Phase III development by the end of the decade. We're also well on track there. And Karl mentioned earlier, in fact, we'll have 10 clinical stage molecules by the end of this year, and those are all moving rapidly through into late-stage development, including FB102 that's ready for Phase III. So I have strong conviction that we're well on track for Vision 2030. And I think we're setting ourselves up for growth for the next decade beyond as well. Thanks for the question. Operator: Our next question will come from Yaron Werber with TD Cowen. Yaron Werber: Maybe a quick, kind of, 2 interrelated questions on empa. Number one, you've shown data that there's been obviously concerns about infections in the class, which really have not been an issue so far. But you've shown data that C2 and C1s are very similar on infection risk and low and they're much lower than C5. Can you discuss the biology of that? And then secondly, just on superiority, maybe for Luc, your -- our understanding is that it's a 3-day moving average, whereas non-inferiority is a 28-day moving average. Why is there a difference? It almost seems that the 3-day is, sort of, in a good way, is a tailwind for superiority. Luc Truyen: Yes. Thanks for that question. And you are correct that given the selection of our molecule to target C2 was pretty purposefully aimed at maximizing our opportunity to have effect across diseases that were caused by both classical or lectin pathway while not affecting the alternate pathway. And that in studies we have conducted leads to our ability to kill encapsulated bacteria that, that is maintained. The C1s, as you point out, has still a similar capability, but then maybe not the same breadth of indications it could target. Hence, our selection of that part of the complement pathway. With respect to the superiority endpoint, the non-inferiority one where we have a 4-week moving average selected was based on the conversations with the FDA to ensure that it's a solid evaluation over that month. The 3-day moving average for the superiority was not further discussed, and we felt that, that was the appropriate way to continue to test this hypothesis of superiority. So we didn't change that. Operator: Our next question will come from Yatin Suneja from Guggenheim. Yatin Suneja: Maybe just a few on FB102. Could you just talk about the competitiveness of the data that you have generated internally in celiac relative to the other approaches? And then for celiac, it seems like you are definitely moving into Phase III. What about vitiligo? You already have that data in hand. So what are the future plans? And anything you can share on the upcoming alopecia data coming up? Karen Massey: Yes. Thanks for the interest in FB102. Maybe I'll take the first question and Luc, if you want to comment on the clinical development. But yes, in terms of the competitiveness, I think here, once we -- based on the Phase II data, it, sort of, confirms our hypothesis that we had with the acquisition just a few months ago. I think we have a potential first-in-class and best-in-class asset with FB102. So the Phase II data was consistent with what we expected and was really exciting. I mean, seeing the efficacy effect on the histology and the symptom outcomes as well as maintaining that safety profile. So I think we have a great molecule here. And as you said, we have strong celiac data, but we also have the potential for additional indications, 2 of them you mentioned, vitiligo and alopecia. I'll have Luc comment on those. But we're also looking beyond those indications to really build this as a pipeline in a product. But Luc, perhaps you can comment on the status of those indications. Luc Truyen: Well, so for celiac, we, of course, fully and very busy in developing a Phase III plan that we will move forward with as fast as we can. For vitiligo, again, with the data in hand, again, showing this biology at work, we're doing the same. What is the most efficient path to patients? And we will roll that out as we get confirmatory conversations with authorities that it's the appropriate plan. Karen Massey: And I think the last thing I'll say is we expect at JPMorgan or early part of next year to be able to provide a more holistic or more detailed update. Operator: Our next question will come from Alex Thompson with Stifel. Alexander Thompson: Congrats on the quarter. I guess ours is on futility analysis. I guess you've now had futility analyses of discontinued programs in Sjögren's and TED. I guess looking forward, should we assume that all your pivotals have built-in futility analysis as we think about data next year in CIDP for empasiprubart and potentially later for efgartigimod in Graves'? Karen Massey: Yes. Thanks for the question, Alex. It's an important one. As we pursue our strategy, which is novel biology and exploring the -- really the boundaries of that biology, we continue to make bold choices about where we're going to invest. And we want to try to develop our assets by moving early, moving fast and then also stopping early. So to your point, we're very disciplined about making sure we have measures like futility analysis in our studies so that we can make disciplined choices at the right moment. And you saw that with Sjögren's when we heard that data. So yes, you can expect that in our development programs, we always have built-in mechanisms to make sure that we're making the right choice and making the right disciplined investments without reducing the calculated risk that we're taking on the biology. Thanks for the question. Operator: Our next question will come from Danielle Brill with Truist. Danielle Brill Bongero: So Karen, you mentioned up to 5 potential launches in 2027, which appears to include empa and MMN. Is that correct? And if so, what assumptions would support a priority review eligibility following the December readout? Would non-inferiority be sufficient? Or is superiority potentially gating to an expedited review in '27 launch? Karen Massey: Yes. Thanks for the question. So yes, the 5 potential launches in the U.S. does include MMN if we -- once we get the data readout. And assuming positive data, then our plan would be to apply for priority review for empasiprubart in MMN. And that we believe that we meet the criteria or that it would meet the criteria. Let's see the data and have the data card turn over. But based on the unmet need and in MMN, we will likely apply for priority review. So let's see the data at the end of the year, but we're planning for success with the potential of 5 launches. Operator: Our next question will come from Myles Minter with William Blair. Myles Minter: Congrats on the quarter. Just on FB102 and the Phase III celiac trial design, can you comment a little bit more there? I mean, obviously, the length and particularly the type of gluten challenge appears to be a variable across trials here. And where are you on moving from IV to a sub-Q formulation for that product? Karen Massey: Yes. I can comment on your second question, Myles. We very much have a plan to move from IV to subcutaneous as quickly as possible. That's part of the VYVGART playbook that we're applying, and it's now part of the argenx playbook for both for empasiprubart as well as FB102. So you can expect that. And maybe, Luc, you want to comment a little bit on the gluten challenge question? Luc Truyen: Well, I mean, the bigger question is which celiac patients do we want to affect. And given what we've seen confirming the biology at work, we feel there should not really be a limitation on which patient you start -- would start treating. So we have to design our development plan so that we can cater to the -- across the spectrum of celiac. And in that sense, also follow what we did in MG, which is leave no patient behind. Operator: Our next question will come from Rajan Sharma with Goldman Sachs. Rajan Sharma: Maybe one for Karl, and I guess, Karen as well. There's obviously been a lot of discussion around OpEx. So I just wanted to check in on your latest thoughts for providing some kind of formal guidance for 2027 and beyond given that you've got multiple launches, label expansions, potentially a second asset as well as the acquisition to integrate. I guess is -- do you think the company is now at a point in time where the market would benefit from some form of formal guidance on the shape of the business on the forward? Karen Massey: Yes. Karl, do you want to comment? Karl Gubitz: Yes. I mean, I think we will talk about it at JPMorgan because I think that's where we -- beginning of next year. But where we are today is I think that we have broad alignment on the opportunities between us and the Street in terms of where the revenue number could go. There's also a lot of variables in terms of binary events. So I think that makes it a little bit difficult to give revenue guidance. But in terms of OpEx, we want to make sure that The Street understands the investment opportunities which we have and what we invest in. So I think we will probably look to provide better clarity or more clarity on the expense number, but probably not on the revenue number. Karen Massey: Thanks, Karl. And maybe just to -- I think that's a good summary. And just to reinforce the strategy here, which you mentioned earlier, which is we are investing for growth and innovation while also delivering on margin expansion. I think that's important and will continue. Operator: Our next question will come from Samantha Semenkow with Citi. Jing Deng: This is Jing on for Sam. And congratulations on the strong quarter. My question is most on the -- also on the celiac. Can you share at a high level your expectations for Phase III design? Is the challenge trial being considered? Or if so, how should we think about the retention of the placebo participants? And also for broadly, so what gives you the confidence that FB102 can become a major growth pillar beyond VYVGART? Karen Massey: Yes. Thanks for the question. So in terms of your second question, I think FB102 or and specifically the target CD122, the reason for our interest in that is that we see pipeline in a product potential, so multiple indications. And we just talked through what some of those are. Celiac, vitiligo, we already have positive data, alopecia, and we think there's more indications beyond that, and we'll be ready to share that in the early part of the new year once we work those up. So when you start to put all of those indications together, where there's significant patient population, significant unmet need. And as I mentioned earlier, we think a potential first-in-class and best-in-class asset, then you can really see that this starts to become a growth driver and pillar alongside VYVGART. In terms of the celiac design in the Phase III study, maybe I'll just comment. I mean you're asking specifically about the placebo retention rates. And I think you called out something really important, which is how you design the gluten challenge in these studies is going to be really important because how intense of a gluten challenge do you want, how long should that gluten challenge be so that you can really see the impact on placebo. But to your point, you balance that with not having too many patients drop out. And I think what Luc was talking about earlier around that, that might look different depending on the symptomatic versus the non-symptomatic patients. That's all of the work that we're doing. We have experts on the team. We're consulting with KOLs. And I think the Forte team has had really productive discussions and input also from regulators over the past number of months and years. So we're well positioned. We're taking all of that into account, and we'll look forward to sharing the details of the design when they're ready. Thanks for the question. Operator: Our next question will come from Sean Laaman with Morgan Stanley. Sean Laaman: I've got an empa question. So with the EMPASSION study reading out in December, beyond simply meeting the primary endpoint, what do you think you need to show to drive meaningful physician adoption? And if ultimately, empa also reads out well in CIDP, how do you position it against VYVGART? Do you see them as competing products, patient segmentation, sequencing or combination? Karen Massey: Yes. Thanks for the question. I'll hand it over to Sandrine to comment on how we compete in MMN. But maybe just briefly to comment on your question on CIDP. I mean this is another place where we said there hasn't been innovation for decades. And obviously, with VYVGART, we brought that innovation and you can see the impact and the growth that VYVGART is having. At the same time, we see that -- we saw that in the ADHERE study, there were some nonresponders to VYVGART. We had the highest response rate that has been seen, but there are some nonresponders. So it clearly is a heterogeneous disease, and there are multiple factors that are driving the disease. So our approach is that we believe that empasiprubart might be able to provide benefit to those patients. We've enrolled all comers, so we'll be able to see the true impact of empasiprubart. Once we get both of those data sets, we'll be able to analyze them, look at the biomarkers and really understand, I think, better than anyone else in the industry, what is really driving this disease and what's the most appropriate treatment for the different patient types. So we really hope to advance outcomes and advance understanding of the biology by having both of these mechanisms in CIDP. And I think it will allow us to really shape the market and certainly lead the market in CIDP. But maybe, Sandrine, you can also comment on the more near-term opportunity of MMN for empasiprubart if the study reads out positively. Sandrine Piret-Gerard: Thanks, Karen, and thanks, Sean, for the great question. So non-inferiority versus IVIg in our MMN trial, we see that as a success. And the superiority would be an add-on and upside. And why do I say that is because when you look at MMN, it has the highest use of IVIg across all indications and disease. Patients can spend up to 2 days in a row with an infusion. I mean, just to give you an idea, this is really burdensome and absolutely not convenient and being able to come with something that is at least as good in terms of efficacy as IVIg, but provide this convenience starting with an IV once a month, 1 or 2 hours and then moving to subcutaneous and an auto-injector long term. This is really a plus and it is clinically meaningful for patients. Actually, at AANEM, I had the opportunity to have dinners with MMN patients, and I was sitting for a few hours between 2 MMN patients, and they were describing their life, what it is to actually live with MMN and having to plan your life around your infusion that are super burdensome. They're extremely excited by the opportunity that empa would offer in MMN, and we're also very excited. So non-inferiority versus IVIg is a bold R&D design, I would say, provide an amazing value proposition for prescribers, for providers and for patients. And then if we have superiority, this is really an upside. Operator: Our next question will come from Sophia Graeff with JPMorgan. Sophia Graeff Buhl Nielsen: You've referred to IMNM before being a CIDP-like opportunity. How are you thinking about the relative ramp compared to uptake in CIDP? Could it be relatively more rapid given the less entrenched position of IVIg in this indication? You referred to the high degree of unmet need there today, but -- or could it be less so given the more limited overlap with your existing prescriber base? Karen Massey: Yes. Maybe I can start and then hand over to Sandrine to talk a little bit about the preparation for IMNM launch and those prescribers. But from an IMNM perspective, I do -- we see it as a large opportunity, as you said. I think in terms of launch trajectory, one thing that's important to take into consideration that we always say, we will need to -- we will take about 2 quarters to -- once after approval to be able to get payer policies in place. So from a -- when you compare the launch uptake to something like a CIDP, I would take that into account. But I do think it's important to take into consideration once we have those payer policies in place, that IMNM has no other treatment options available. These patients are waiting. And so I think they will be -- both patients and prescribers will be excited. But maybe, Sandrine, you can comment on how we're preparing for that launch. Sandrine Piret-Gerard: Yes, we are getting ready. I mean -- so we are all very, very excited, as you can imagine, we can help up to 20,000 patients actually. This is the size of the opportunity. And it could even be bigger because we feel that a lot might be misdiagnosed or not diagnosed well. So given that high unmet need, we think that the uptake and the adoption will be pretty fast. So we have been gearing up for success. And actually, we have set up already a medical team since a while. They have been in the field speaking about the disease itself and some of our data. So we already can leverage the amazing patient services that we have, patient support program, but also everything we have done with payers, and we are a known entity there. So this is something which we don't have to reinvent from scratch. And we are in the midst -- if you look on LinkedIn, I mean, we are in the midst of expanding our field force and sales team focusing on rheumatologists. So exciting time for us. And we know that some of the prescription will come from neurologists. And there, we already have a foot in the door since 5 years. And so -- and this should be even easier than with rheumatologists. So that's something we will leverage as well. So I would say we were gearing up for success. We are in the midst of the preparation. And now we just need to get the approval, which is not a detail, but important. So thank you for the question. Operator: Our next question will come from Luca Issi with Royal Bank of Canada. Luca Issi: Congrats on the progress. Maybe, Luc, if I can circle back on a prior question for dermatomyositis. Can you just maybe talk about why the FDA told you that you couldn't file on the ALKIVIA data despite very impressive 15 points improvement in TIS, if I recall it correctly. And obviously, in the context of the drug that is already approved and we know it's very safe. And then maybe related to it, how long will it take to run this additional trial that the FDA is asking you? I think Roivant took exactly 4 years from the time the pivotal trial was actually posted on clinicaltrials.gov to the actual approval for brepocitinib. Is that the right comp for us to think about it? Or do you think you can beat that? Luc Truyen: Yes. Thank you for that question. So it was actually first principles, I think, in interaction with the FDA for the DM discussion. As you recall from our disclosures earlier, we missed the primary endpoint. And even though the magnitude of the effect size was exactly as we had seen in IMNM and very consistent, it was felt that this was a really great hypothesis generating data, but that it needed confirmatory evidence. Now as we're still designing the program, I'm not going to speculate on duration. This will be a matter of agreement with the agency what it would take. The one thing I will say is we have already data in hand on DM, which would inform sizing and effect appreciation and so forth. So... Karen Massey: Yes. And I think it's fair to say that our goal is to go as fast as possible. I think we have a track record of being able to beat industry averages. So we'll be working hard. Thanks for the question. Operator: Our next question will come from Douglas Tsao with H.C. Wainwright. Douglas Tsao: Maybe I would just be curious to hear from Sandrine from her perspective from coming back from AANEM because at the conference, it was really striking how many of the podium presentations were focused on both seronegative as well as ocular. Obviously, you saw some strong momentum already with the seronegative, but I'm curious what feedback you might have gotten from clinicians. Karen Massey: Sandrine? Sandrine Piret-Gerard: So yes, thank you for your question. So indeed, I was at AANEM and the feedback, I must say, has been extremely positive. We see in the numbers of seronegative that providers have jumped on the opportunity, especially for triple-seronegative patients, and they're all very excited about ocular MG. Actually, when you speak to them because the question I ask them is how do you see -- do you consider this as a mild disease because some physicians say that the majority say it's absolutely not mild. The symptoms you're having are fully debilitating. People cannot read, cannot drive. It's really impacting the quality of life. So they really look forward to having a solution and option to offer them. So the many interactions we had during the congress were very, very encouraging, and it was more a question of when we will be able to offer that as soon as we can because patients are really waiting. So -- and as you have seen since you have looked at AANEM, I mean, there are not many, many other options, and they are coming much later than us. So I think coming first there will be a key advantage, and we think it will have a halo effect like seronegative had. Operator: Our last question will come from Allison Bratzel with Piper Sandler. Allison Bratzel: Just going back to the UNITY futility decision, I guess, could you talk to -- do you have a sense of whether that outcome was specific to Sjögren's biology, its trial design, something else? And just does that change your confidence in pursuing other rheumatology indications like systemic sclerosis? And just lastly, could you just talk to the commitment to addressing Sjögren's with other mechanisms or other assets in the argenx pipeline? Karen Massey: Yes. Thanks for the question. So after the futility analysis, we actually haven't seen the data yet. We're still going through the process of closing out that study so that we'll be able to get the data. It will be a rich data set. About 500 patients made it to week 24. So we'll have a very strong data set. So we'll be able to analyze and really understand what was driving the futility analysis. So more to come on that. But I think what you can expect is that after we've done that analysis and really understood, we'll be able to define then and we'll share what's the path forward, either for FcRn if we maybe see a patient population or something like that, where it made a difference or certainly, we'll use those insights to inform our future pipeline programs for Sjögren's. We're looking to be a leader in immunology, and Sjögren's is obviously an area with high unmet need. So we'll continue to look and continue to invest, and we'll be able to leverage that data set to inform those decisions. I wouldn't assume that the futility analysis or the outcome for UNITY reads through to any other indications. Each indication that we select stands on its own in terms of the biology, the developability and also the patient -- unmet patient need. So we're looking forward to the scleroderma Phase II study reading out, and there shouldn't be any read-through, but we look forward to that data card turning over. Thanks for the question. Operator: This concludes our conference for today. Thank you for participating. You may now disconnect. Before you buy stock in Argenx Se, consider this: The Motley Fool Stock Advisor analyst team just identified what they believe are the 10 best stocks for investors to buy now… and Argenx Se wasn't one of them. The 10 stocks that made the cut could produce monster returns in the coming years. 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As with all our articles, The Motley Fool does not assume any responsibility for your use of this content, and we strongly encourage you to do your own research, including listening to the call yourself and reading the company's SEC filings. Please see our Terms and Conditions for additional details, including our Obligatory Capitalized Disclaimers of Liability. The Motley Fool has positions in and recommends Argenx Se. The Motley Fool has a disclosure policy. argenx (ARGX) Q3 2026 Earnings Call Transcript was originally published by The Motley Fool

- Interested in argenex SE? Here are five stocks we like better. - Third-quarter sales surged: argenx reported $1.7 billion in product net sales, up 54% year over year and 13% sequentially, driven by continued VYVGART growth in generalized myasthenia gravis and CIDP. Operating profit was $486 million, with a 37% margin excluding $150 million in Forte acquisition costs. - argenx is preparing for significant expansion: The company plans to file for VYVGART approval in immune-mediated necrotizing myopathy by year-end and could have up to five U.S. launches in 2027, including potential MG expansions, an auto-injector and empasiprubart for MMN. - Pipeline investment is increasing: argenx is advancing Forte-acquired FB-102 into Phase III development for celiac disease and expects 10 molecules in clinical development by the end of 2026, while maintaining its Vision 2030 targets of 50,000 patients, 10 labeled indications and five Phase III molecules. - 2 Ways to Play the Big Pharma Patent Cliff argenex (NASDAQ:ARGX) reported third-quarter 2026 product net sales of $1.7 billion, up 54% from a year earlier and 13% sequentially, as patient growth in generalized myasthenia gravis, or MG, and chronic inflammatory demyelinating polyneuropathy, or CIDP, continued to support demand for VYVGART. Chief Executive Officer Karen Massey said the company remains early in realizing VYVGART's potential across its current indications while pursuing expansion opportunities in neurology and rheumatology. The company also highlighted its broader pipeline, including empasiprubart in multifocal motor neuropathy, or MMN, and FB-102 in celiac disease. → Aurora Rejects Curaleaf's Higher Bid, But the Takeover Fight Isn't Over - 3 Healthcare Pathbreakers With Long-Term Tailwinds U.S. product net sales totaled $1.5 billion during the quarter, rising 16% from the prior quarter. Sales were $81 million in Japan, $158 million across other international markets, and $11 million from products supplied to Zai Lab in China. Management said U.S. net pricing was broadly consistent with prior quarters, while gross-to-net deductions were 22%. Chief Financial Officer Karl Gubitz said the company generated operating profit of $486 million, representing a 28% operating margin. Excluding $150 million of Forte acquisition-related transaction costs, operating margin was 37%. → Could Quantinuum's Breakthrough Make Its Sell-Off a Bargain? - 5 medical stocks growing earnings by triple digits Total operating expenses were $1.3 billion. Combined research and development and selling, general and administrative expenses were $1.1 billion, up 22% sequentially. Excluding the Forte transaction costs, the increase was 5%, according to the company. argenx ended the quarter with $3.7 billion in cash equivalents and current financial assets after paying a net $2.1 billion for the Forte acquisition. The company expects combined R&D and SG&A expenses of approximately $4 billion for 2026, incorporating Forte-related costs, investment in FB-102, pipeline development and commercial preparations following positive ALKIVIA results. → IonQ's Bold Expansion Could Leave Shareholders Paying the Price Gubitz said roughly half of the increase in 2026 expense expectations versus prior Street expectations relates to Forte, including the $150 million charge recorded in the third quarter and roughly $50 million in FB-102 operating costs for the remainder of the year. He said argenx expects to provide more expense clarity for 2027 at the JPMorgan healthcare conference, while cautioning investors not to assume another 45% year-over-year increase in spending. Chief Commercialization Officer Sandrine Piret-Gerard said both MG and CIDP continued to grow during the quarter, with neither indication showing a slowdown. In MG, she said the recent seronegative label expansion was a meaningful contributor to growth and had secured coverage for approximately 96% of covered lives. Most payers have removed serotype testing from VYVGART coverage policies, simplifying prescribing for generalized MG patients, according to Piret-Gerard. About 10% of prescribers treating seronegative patients were new to VYVGART, and the company said experience in seronegative patients has increased use among acetylcholine receptor antibody-positive patients as well. The company has submitted supplemental biologics license applications for pediatric and ocular MG. The pediatric MG application has a Prescription Drug User Fee Act date in February 2027. Massey said approval in ocular MG would extend VYVGART beyond generalized MG for the first time, while a VYVGART Hytrulo auto-injector is expected in the second half of 2027. In CIDP, argenx said adoption continued to expand among both patients and prescribers. The company cited open-label extension data from ADHERE and ADHERE+ showing that nearly 40% of initial VYVGART responders reached an INCAT score of zero or one, indicating little to no functional disability. It also pointed to Phase IV data supporting a one-week transition from intravenous immunoglobulin, or IVIG. argenx plans to file an sBLA for VYVGART in immune-mediated necrotizing myopathy, or IMNM, by year-end. The program has breakthrough therapy designation. Management described IMNM as an urgent unmet need, noting that patients can deteriorate rapidly and that there are no approved treatments. The company estimates approximately 20,000 people in the U.S. are living with IMNM. Positive Phase III ALKIVIA results supported the IMNM filing, according to Massey. The data also showed clinically meaningful results in dermatomyositis, or DM, but the company said it will conduct an additional registrational study in DM after discussions with the Food and Drug Administration. Chief Medical Officer Luc Truyen said the prior study missed its primary endpoint in DM despite an effect size consistent with IMNM, and the FDA requested confirmatory evidence. Management said argenx could have up to five U.S. launches in 2027, including potential MG label expansions, IMNM, the auto-injector and a possible MMN launch for empasiprubart. The Phase III EMPASSION study of empasiprubart against IVIG in MMN is expected to read out in December. The company is not publicly disclosing the trial's non-inferiority margin. Truyen said the study was designed to assess whether empasiprubart can match IVIG efficacy while reducing treatment burden, with superiority representing a potential additional outcome. If results are positive, Massey said argenx plans to seek priority review, based on the unmet need in MMN. Piret-Gerard said non-inferiority to IVIG would be a successful outcome because MMN patients often require burdensome infusion schedules, while empasiprubart could initially be administered intravenously monthly and potentially transition to subcutaneous administration and an auto-injector over time. Beyond VYVGART and empasiprubart, argenx highlighted positive Phase II results for FB-102 in celiac disease following the Forte acquisition. Management said the results were consistent across efficacy measures, including symptoms and histology, and showed a favorable safety profile. The company is preparing a Phase III development plan in celiac disease and expects to move the asset from intravenous to subcutaneous administration as quickly as possible. The company also sees potential for FB-102, which targets CD122, in vitiligo, alopecia and additional autoimmune conditions. Management said it expects to provide a more detailed update on the asset's broader development strategy in early 2027. Other pipeline programs include adimanebart, which is advancing to Phase III in congenital myasthenic syndrome, and ARGX-121 in Phase II for IgA nephropathy. argenx expects to have 10 molecules in clinical development by the end of 2026. Massey reaffirmed the company's Vision 2030 targets of reaching 50,000 patients, securing 10 labeled indications and having five molecules in Phase III development by the end of the decade. She said MG and CIDP are expected to account for the majority of patient growth, with additional contributions anticipated from IMNM, MMN and other potential approvals. Management also stressed its use of futility analyses across development programs after discontinuing programs in Sjögren's syndrome and thyroid eye disease. Massey said the company had not yet reviewed the full Sjögren's data set but expects the approximately 500 patients who reached week 24 to provide insights for future development decisions. She said the outcome should not be viewed as a read-through to the company's other rheumatology programs, including its Phase II systemic sclerosis study. argenx SE (NASDAQ: ARGX) is a global immunology company focused on developing and commercializing therapies for patients with severe autoimmune diseases. The company uses its antibody engineering capabilities to discover and advance medicines designed to target disease-causing immune mechanisms. argenx's lead product is VYVGART (efgartigimod alfa), an antibody fragment that targets the neonatal Fc receptor, or FcRn, to reduce levels of disease-causing immunoglobulin G antibodies. VYVGART is approved in several markets for the treatment of generalized myasthenia gravis. This instant news alert was generated by narrative science technology and financial data from MarketBeat in order to provide readers with the fastest reporting and unbiased coverage. Please send any questions or comments about this story to [email protected]. The article "What argenex (ARGX) Said on Its Q3 Earnings Call" was originally published by MarketBeat. View MarketBeat's top stocks for October 2026.

Continued strong VYVGART performance drives $1.7 billion in global product net sales, representing 54% year-over-year growth and 13% quarter-over-quarter growth sBLA for VYVGART Hytrulo in IMNM on track for submission by year-end; pursuing additional registrational study in DM Phase 3 MMN data for empasiprubart expected in December 2026 FB102 advancing to Phase 3 in celiac disease as potential new growth pillar in argenx's next wave of immunology innovation Management to host conference call today at 2:30 PM CET (8:30 AM ET) October 22, 2026 7:00 AM CET Amsterdam, the Netherlands - argenx SE (Euronext & Nasdaq: ARGX), the immunology innovation company, today announced its third quarter 2026 results and provided a business update. "The story of argenx is one of continued innovation, growth and impact," said Karen Massey, Chief Executive Officer. "VYVGART is the foundation of our business and continues to deliver strong performance across gMG and CIDP, with significant opportunity still ahead as we reach more patients, expand into new indications, and advance the next wave of FcRn medicines. The positive results from our Phase 3 ALKIVIA study further reinforce the potential of VYVGART beyond neurology, and underscore how much more it can deliver for patients. The upcoming Phase 3 readout for empasiprubart in MMN, the advancement of FB102, and progress across our emerging immunology pipeline are bringing the next chapter of argenx into focus as we build a global immunology innovator positioned for durable growth and value creation well beyond Vision 2030." Vision 2030 argenx remains on track to achieve its 'Vision 2030' anchored in the ambition to treat 50,000 patients globally with its medicines, secure 10 labeled indications, and progress five pipeline candidates into registrational development by 2030. Realizing the full potential of VYVGART and advancing FcRn leadership VYVGART® (IV: efgartigimod alfa-fcab; SC: efgartigimod alfa and hyaluronidase-qvfc) is the first-and-only approved treatment for all adult patients living with generalized myasthenia gravis (gMG). It is also approved for chronic inflammatory demyelinating polyneuropathy (CIDP) globally, and primary immune thrombocytopenia (ITP) in Japan. Building on VYVGART's leadership in MG and CIDP, argenx is progressing multiple label and indication expansions, exploring VYVGART's potential in additional autoimmune diseases through proof-of-concept studies, and advancing next-generation FcRn molecules and delivery modalities. - Generated $1.7 billion in global product net sales in the third quarter of 2026, representing 54% year-over-year growth and 13% quarter-over-quarter growth - Submitted a Supplemental Biologics License Application (sBLA) for VYVGART in ocular myasthenia gravis (oMG) to the U.S. Food and Drug Administration (FDA) - sBLA for VYVGART and VYVGART Hytrulo in pediatric gMG accepted for priority review by the FDA with a PDUFA target action date in February 2027 - VYVGART Hytrulo autoinjector expected to launch in second half of 2027 for all approved indications - Reported positive Phase 3 ALKIVIA results with consistent and clinically meaningful treatment effects observed across immune-mediated necrotizing myopathy (IMNM) and dermatomyositis (DM); sBLA for VYVGART Hytrulo in IMNM on track for submission by year-end 2026, supported by Breakthrough Therapy Designation, with plans to conduct an additional registrational study in DM - Topline results from Phase 3 ADVANCE-NEXT study in primary ITP expected in first half of 2027 - Phase 3 VitaliThy studies in Graves' disease ongoing - Advancing the future FcRn portfolio, including Phase 3-ready ARGX-213, designed for monthly dosing, and ARGX-124 currently in Phase 1 development Advancing empasiprubart, argenx's second pipeline-in-a-product opportunity Empasiprubart (anti-C2) is argenx's second pipeline-in-a-product opportunity and is being evaluated in Phase 3 studies in multifocal motor neuropathy (MMN) and CIDP, with additional Phase 2 studies exploring its potential in other indications and in combination with VYVGART in gMG. - Topline results from the Phase 3 EMPASSION study (MMN) expected in December 2026 - Topline results from Phase 3 EMVIGORATE and EMNERGIZE studies in CIDP anticipated in the second half of 2027 - Phase 2 ADAPT-Forward platform study in gMG ongoing, evaluating empasiprubart as an add-on to efgartigimod and as monotherapy to support combination development pathway Delivering next wave of immunology innovation Beyond the FcRn portfolio and empasiprubart, argenx is advancing a differentiated immunology pipeline that includes FB102 (CD122), adimanebart (MuSK), ARGX-121 (IgA), ARGX-109 (IL-6), TSP-101 (Fn14), ARGX-118 (Galectin-10) and ARGX-125 (undisclosed target), together with additional candidates emerging from the Immunology Innovation Program. These programs support argenx's ambition to build multiple pillars of sustainable growth beyond Vision 2030. - Advancing FB102 to Phase 3 in celiac disease based on positive Phase 2 results, with ongoing programs in alopecia areata and vitiligo and potential across other autoimmune diseases - Phase 3 study of adimanebart in congenital myasthenic syndromes (CMS) expected to begin in 2026; Phase 2 in spinal muscular atrophy (SMA) ongoing - Phase 2 study of ARGX-121 in IgA nephropathy (IgAN) ongoing - Advancing Phase 1 development of TSP-101, ARGX-118 and ARGX-125 THIRD QUARTER 2026 FINANCIAL RESULTS argenx SE UNAUDITED CONDENSED CONSOLIDATED INTERIM STATEMENTS OF PROFIT OR LOSS | | Three Months Ended | | Nine Months Ended | | September 30, | | September 30, (in millions of $ except for per share data) | | 2026 | | 2025 | | 2026 | | | 2025 Product net sales | | $ | 1,721 | | $ | 1,127 | | $ | 4,534 | | $ | 2,866 Other operating income | | | 30 | | | 24 | | | 71 | | | 60 Total operating income | | $ | 1,751 | | $ | 1,151 | | $ | 4,605 | | $ | 2,926 | | | | | | | | | | | | Cost of sales | | $ | (165) | | $ | (109) | | $ | (431) | | $ | (301) Research and development expenses* | | | (503) | | | (359) | | | (1,432) | | | (1,001) Selling, general and administrative expenses | | | (598) | | | (336) | | | (1,370) | | | (937) Total operating expenses | | $ | (1,266) | | $ | (805) | | $ | (3,233) | | $ | (2,240) | | | | | | | | | | | | Operating profit | | $ | 486 | | $ | 346 | | $ | 1,372 | | $ | 686 | | | | | | | | | | | | Financial income | | $ | 45 | | $ | 43 | | $ | 137 | | $ | 118 Financial expense | | | (1) | | | (1) | | | (3) | | | (3) Exchange gains/(losses) | | | 8 | | | (2) | | | (11) | | | 74 | | | | | | | | | | | | Profit for the period before taxes | | $ | 538 | | $ | 386 | | $ | 1,495 | | $ | 875 Income tax expense | | $ | (32) | | $ | (42) | | $ | (151) | | $ | (116) Profit for the period | | $ | 506 | | $ | 344 | | $ | 1,344 | | $ | 759 Profit for the period attributable to: | | | | | | | | | | | | Owners of the parent | | $ | 506 | | $ | 344 | | $ | 1,344 | | $ | 759 Weighted average number of shares used for basic profit per share | | | 62,735,385 | | | 61,371,508 | | | 62,370,746 | | | 61,147,873 Basic profit per share (in $) | | | 8.07 | | | 5.61 | | | 21.54 | | | 12.41 Weighted average number of shares used for diluted profit per share | | | 64,886,406 | | | 66,441,326 | | | 64,578,235 | | | 65,944,952 Diluted profit per share (in $) | | | 7.80 | | | 5.18 | | | 20.81 | | | 11.51 *Comparative figures have been aligned with the presentation adopted in the current period, reflecting the combination of research and development expenses and loss from investment in a joint venture. DETAILS OF THE FINANCIAL RESULTS Total operating income for the three and nine months ended September 30, 2026 was $1.8 billion and $4.6 billion, respectively, compared to $1.2 billion and $2.9 billion, respectively, for the same periods in 2025, and mainly consisted of: - Product net sales of VYVGART for the three and nine months ended September 30, 2026, were $1.7 billion and $4.5 billion, respectively, compared to $1.1 billion and $2.9 billion, respectively, for the same periods in 2025. - Other operating income for the three and nine months ended September 30, 2026 was $30 million and $71 million, respectively, compared to $24 million and $60 million, respectively, for the same periods in 2025. The other operating income in these periods primarily related to research and development tax incentives and payroll tax rebates. Total operating expenses for the three and nine months ended September 30, 2026 were $1.3 billion and $3.2 billion, respectively, compared to $0.8 billion and $2.2 billion, respectively, for the same periods in 2025, and mainly consisted of: - Cost of sales for the three and nine months ended September 30, 2026 was $165 million and $431 million, respectively, compared to $109 million and $301 million, respectively, for the same periods in 2025. The cost of sales was related to the sale of VYVGART. - Research and development expenses for the three and nine months ended September 30, 2026 were $0.5 billion and $1.4 billion, respectively, compared to $0.4 billion and $1.0 billion, respectively, for the same periods in 2025. The research and development expenses mainly related to advancing efgartigimod, empasiprubart, adimanebart and FB102 across multiple registrational studies, plus early-stage pipeline and preclinical programs. - Selling, general and administrative expenses for the three and nine months ended September 30, 2026 were $0.6 billion and $1.4 billion, respectively, compared to $0.3 billion and $0.9 billion, respectively, for the same periods in 2025. The selling, general and administrative expenses mainly related to professional and marketing fees linked to the global commercialization of the VYVGART franchise, and personnel expenses. Selling, general and administrative expenses for the three- and nine-month periods ended September 30, 2026 included approximately $150 million of acquisition-related expenses associated with the Company's acquisition of Forte Biosciences Inc. Financial income for the three and nine months ended September 30, 2026 was $45 million and $137 million, respectively, compared to $43 million and $118 million, respectively, for the same periods in 2025. Exchange gains/losses for the three and nine months ended September 30, 2026 were an $8 million gain and an $11 million loss, respectively, compared to a $2 million loss and a $74 million gain, respectively, for the same periods in 2025. Income tax for the three- and nine-month periods ended September 30, 2026 and 2025 is detailed below: | | Three Months Ended | | Nine Months Ended | | September 30, | | September 30, (in millions of $) | | 2026 | | 2025 | | 2026 | | 2025 Current tax expense | | $ | (129) | | $ | (52) | | $ | (359) | | $ | (122) Deferred tax benefit | | | 97 | | | 10 | | | 208 | | | 6 Income tax expense | | $ | (32) | | $ | (42) | | $ | (151) | | $ | (116) Profit for the three- and nine-month periods ended September 30, 2026 was $0.5 billion and $1.3 billion, respectively, compared to $0.3 billion and $0.8 billion, respectively, for the same periods in 2025. The basic profit per share was $8.07 for the three months ended September 30, 2026, compared to $5.61 for the same period in 2025. The basic profit per share was $21.54 for the nine months ended September 30, 2026, compared to $12.41 for the same period in 2025. Cash, cash equivalents and current financial assets1 consisted of $2.6 billion in cash and cash equivalents and $1.1 billion in current financial assets which totaled $3.7 billion as of September 30, 2026 after paying approximately $2.1 billion for the acquisition of Forte Biosciences Inc., net of acquired cash, compared to $3.5 billion in cash and cash equivalents and $0.9 billion in current financial assets which totaled $4.4 billion as of December 31, 2025. FULL YEAR EXPECTATIONS Combined R&D and SG&A expenses are now expected to be approximately $4 billion for 2026, including the Forte transaction-related costs. EXPECTED FINANCIAL CALENDAR - February 25, 2027: Full-year 2026 Financial Results and Fourth Quarter 2026 Business Update - April 29, 2027: First Quarter 2027 Financial Results and Business Update - July 22, 2027: Half Year and Second Quarter 2027 Financial Results and Business Update - October 21, 2027: Third Quarter 2027 Financial Results and Business Update CONFERENCE CALL DETAILS The third quarter 2026 financial results and business update will be discussed during a conference call and webcast presentation today at 2:30 PM CET/8:30 AM ET. A webcast of the live call may be accessed on the Investors section of the argenx website at argenx.com/investors. Participants can access the conference call by dialing 800-590-8290 (United States and Canada) or 240-690-8800 (International). Country specific dial-in numbers are listed below: Belgium 32 2290 4635 France 33 172 001717 Netherlands 31 20 795 2683 United Kingdom 44 203 393 1560 Japan 81 3 4520 9761 Switzerland 41 43 210 51 68 Use the access code 3810049 to join the call. Please dial in 15 minutes prior to the live call. A replay of the webcast will be available on the argenx website. About VYVGART VYVGART® (efgartigimod alfa fcab) is a first-in-class human IgG1 antibody fragment that binds to the neonatal Fc receptor (FcRn), resulting in the reduction of circulating IgG autoantibodies. VYVGART Hytrulo® is a subcutaneous combination of efgartigimod alfa (VYVGART) and recombinant human hyaluronidase PH20 (rHuPH20), Halozyme's ENHANZE® drug delivery technology to facilitate subcutaneous injection delivery of biologics. VYVGART is approved for generalized myasthenia gravis (gMG) and immune thrombocytopenia (Japan only). VYVGART Hytrulo is approved for gMG and chronic inflammatory demyelinating polyneuropathy (CIDP). VYVGART Hytrulo may be marketed under different proprietary names in other regions. About argenx argenx is the immunology innovation company, focused on turning immunology breakthroughs into medicines for patients. The company seeks novel biology wherever it emerges, co-creating with academic researchers through its Immunology Innovation Program (IIP) and investing in promising science, to develop treatments for people living with underserved diseases. By advancing molecules with the potential to reach multiple diseases and patient populations, argenx is building a world-class portfolio. This approach produced the first approved antibody fragment targeting the neonatal Fc receptor (FcRn) and today powers a growing pipeline of early and late-stage programs across several therapeutic areas. For more information, visit www.argenx.com and follow us on LinkedIn, Instagram, Facebook, and YouTube. This press release contains inside information within the meaning of Article 7(1) of the EU Market Abuse Regulation (Regulation 596/2014). Contacts Media: Ben Petok [email protected] Investors: Alexandra Roy [email protected] Forward Looking Statements The contents of this announcement include statements that are, or may be deemed to be, "forward-looking statements." These forward-looking statements generally can be identified by the use of forward-looking words, such as "ahead", "aim", "ambition," "anticipate", "aspire", "believe", "can", "continue", "could", "designed for", "estimate", "expect", "entail", "forecast", "future", "goals", "hope", "intend", "is designed to", "likely", "may", "might", "objective", "plan", "possible", "positioned", "potential", "pursue", "project", "predict", "seek", "should", "strategy", "target", "upcoming", "will" and other words and terms of similar meaning and expression, including in connection with any discussion of future operating or financial performance. By their nature, forward-looking statements involve risks and uncertainties and readers are cautioned that any such forward-looking statements are not guarantees of future performance. argenx's actual results may differ materially from those predicted by the forward-looking statements as a result of various important factors, including but not limited to, uncertainties associated with the development of novel drug therapies; the initiation, timing, progress, development and results of preclinical and clinical trials of argenx's product candidates, including new indications, alternative dosing regimens, treatment modalities, and methods of administration, including statements regarding when results or interim analysis of the clinical trials will be available or made public; the risk that early stage clinical trials may not be predictive of results in later stage or large scale clinical trials; the expansion of argenx's business, including the further development of argenx's sales and marketing abilities and its Immunology Innovation Program, and the value of its pipeline; the potential attributes, benefits, and side effects of argenx's products and product candidates, including new indications, alternative dosing regimens and treatment modalities, and their competitive position with respect to other alternative treatments; argenx's ability to advance product candidates into, and successfully complete, clinical trials; argenx's estimates of the number of patients who suffer from the diseases it is targeting and the number of patients that will enroll in its clinical trials; the demand and commercialization of argenx's products and product candidates, including new indications, alternative dosing regimens, treatment modalities, and methods of administration, if approved; the anticipated timing or likelihood of market or regulatory decisions relating to or of argenx's products, including new indications, alternative dosing regimens, treatment modalities, and methods of administration; the anticipated pricing and reimbursement of argenx's products and product candidates, if approved; argenx's plans to have various programs to help patients afford its products, including patient assistance and co-pay coupon programs for eligible patients; argenx's ability to establish sales, marketing and distribution capabilities for any of its products and product candidates that achieve regulatory approval; argenx's regulatory strategy and its ability to establish and maintain manufacturing arrangements for its products and product candidates; the scope and duration of protection, including any exclusivity period, argenx is able to establish and maintain for intellectual property rights covering its products and product candidates, platform and technology, including its intention to seek patent term extensions where available; argenx's estimates regarding expenses, future revenues, cash flow, capital requirements and its needs for additional financing; argenx's expectation that it will benefit from the Belgian innovation income deduction; argenx's financial performance, including potential volatility in the price of its ordinary shares and American Depositary Shares; the acquisition of Forte Biosciences Inc., including argenx's ability to integrate the acquired business and realize its anticipated benefits; the competition argenx faces in its drug discovery, development, and commercialization efforts; the rate and degree of market acceptance of argenx's products and product candidates, if approved, by its patients as safe, effective and cost-effective; the potential benefits of argenx's current collaborations, including the possibility to access partner technology platforms or capabilities; argenx's plans and ability to enter into or maintain current collaborations for additional programs or product candidates; argenx's plans and ability to enter into or maintain current new distribution partnerships; argenx's long-term growth strategy to develop and market additional products and product candidates, including but not limited to, efgartigimod for new indications, empasiprubart, adimanebart, and FB102; the impact of government laws and regulations, including tariffs, export controls, sanctions and other regulations on argenx's business; argenx's expectations with respect to the timing and amount of any dividends (if any); argenx's plans regarding its supply chain, including its reliance on third parties, service providers and manufacturers; inflation and deflation and the corresponding fluctuations in interest rates; regional instability and conflicts; and argenx's business strategies, including Vision 2030, plans, projects, goals and targets and the timing, outcomes and benefits thereof. A further list and description of these and other risks, uncertainties, and factors that could cause actual results to differ materially from those referred to in the forward-looking statements can be found in argenx's U.S. Securities and Exchange Commission (SEC) filings and reports, including in argenx's most recent annual report on Form 20-F filed with the SEC as well as subsequent filings and reports filed by argenx with the SEC. Given these risks and uncertainties, the reader is advised not to place undue reliance on such forward-looking statements. These forward-looking statements speak only as of the date of publication of this press release. argenx undertakes no obligation to publicly update or revise the information in this press release, including any forward-looking statements, except as may be required by law. Alternative Performance Measures Statement In this document, argenx's financial results are provided in accordance with IFRS® Accounting Standards (IFRS) and using a non-IFRS financial measure, cash, cash equivalents and current financial assets. This value should not be viewed as a substitute for the company's IFRS financial information and is provided as a complement to financial information provided in accordance with IFRS and should be read in conjunction with the most directly comparable IFRS financial information as set out below. Management believes this non-IFRS financial measure is useful for securities analysts, investors and other interested parties to gain a more complete understanding of the company's available financial liquidities given that the company's current financial assets are held in term accounts with an initial maturity of more than three months but less than twelve that may be used to meet its financial obligations. Such non-IFRS financial information, as calculated herein, may not be comparable to similarly named measures used by other companies and should not be considered comparable to IFRS financial measures. Non-IFRS financial measures have limitations as an analytical tool and should not be considered in isolation from, or as a substitute for, an analysis of the company's financial results as reported under IFRS. A reconciliation of the IFRS financial information to non-IFRS financial information is included below: Cash, cash equivalents and current financial assets totaled $3.7 billion as of September 30, 2026, compared to $4.4 billion as of December 31, 2025. The balance as of the period ended September 30, 2026 consisted of $2.6 billion in cash and cash equivalents and $1.1 billion in current financial assets and the balance as of the period ended December 31, 2025 consisted of $3.5 billion in cash and cash equivalents and $0.9 billion in current financial assets. 1 A non-IFRS Alternative Performance Measure (APM). Refer to the "Alternative Performance Measures Statement" below for a reconciliation to the IFRS financial information.

This article first appeared on GuruFocus. - Product Net Sales: $1.7 billion, up 54% year over year and 13% quarter over quarter. - US Product Net Sales: $1.5 billion, up 16% quarter over quarter; net pricing broadly consistent with prior quarters. - Japan Product Net Sales: $81 million, up 47% year over year; prior quarter included ~$25 million one-time distribution model benefit. - Rest of World Product Net Sales: $158 million, up 70% year over year on strong underlying demand. - Product Supply to Zai Lab (China): $11 million. - Gross to Net Deductions: 22%, in line with expectations. - Total Operating Expenses: $1.3 billion. - Combined R&D and SG&A Expenses: $1.1 billion, up 22% quarter over quarter; included $150 million Forte transaction-related cost (up 5% excluding it). - Operating Profit: $486 million, a 28% operating margin; 37% adjusted for Forte transaction-related cost. - Effective Tax Rate: 10% year to date. - Cash and Financial Assets: $3.7 billion in cash equivalents and current financial assets after net $2.1 billion payment for the Forte acquisition. - 2026 Expense Guidance: Combined R&D and SG&A expenses of approximately $4 billion. - Warning! GuruFocus has detected 2 Warning Sign with ARGNF. - Is ARGNF fairly valued? Test your thesis with our free DCF calculator. Release Date: October 22, 2026 For the complete transcript of the earnings call, please refer to the full earnings call transcript. - Product net sales reached $1.7 billion, up 54% year over year and 13% quarter over quarter, driven by strong patient growth. - VYVGART's seronegative MG launch is off to a strong start, with ~96% of covered lives having access and a halo effect driving increased prescribing in seropositive patients. - Positive Phase 3 ALKIVIA results support expansion into autoimmune myositis, with an sBLA planned for IMNM by year-end and an additional registrational study planned for DM. - Empasiprubart's Phase 3 IMPASSION study in MMN is expected to read out in December, with potential to offer a differentiated treatment option and reduce treatment burden. - FB102 showed positive Phase 2 results in celiac disease, providing another Phase 3-ready program and potential pipeline-in-a-product across multiple autoimmune indications. - Operating expenses are increasing, with combined R&D and SG&A expected to be ~$4 billion for 2026, up 45% year over year, partly due to the Forte acquisition and pipeline investments. - The FDA required an additional registrational trial for DM despite positive ALKIVIA data, delaying potential approval and adding development costs. - The SJOGren's program (unity) failed a futility analysis, leading to discontinuation and highlighting the risks of novel biology in autoimmune diseases. - Empasiprubart's Phase 3 IMPASSION study uses a non-inferiority design against IVIg, and superiority is not guaranteed, which could impact differentiation and adoption. - The company does not provide formal revenue guidance, and management cited binary events and variables that make revenue forecasting difficult, potentially creating uncertainty for investors. Q: Can you quantify the moving parts behind the increased 2026 OpEx guidance, and what is the outlook for 2027? A: CFO Karl Gubitz explained that the increase to approximately $4 billion is roughly half attributable to the Forte acquisition, including $150 million in Q3 transaction costs and about $50 million in FB102 operating costs for the remainder of the year. The rest reflects commercial investment ahead of the IMNM launch following positive ALKIVIA results and CMC work across 10 clinical-stage assets. He noted 2026 expenses represent a 45% increase over 2025 but cautioned investors not to assume a similar jump in 2027, suggesting roughly half that rate as a placeholder, with formal guidance to come at JPMorgan. Q: What is the non-inferiority margin in the IMPASSION MMN study, and what are your expectations for the IVIg arm? A: CMO Luc Truyen declined to disclose the specific margin but explained the head-to-head design against IVIg was based on Phase 2 ARDA learnings, where the active arm largely avoided the need for IVIg retreatment while untreated patients almost universally required it. He said IVIg performance is expected to match historical and external data, with an in-study check built in since each patient completes two IVIg cycles before randomization. Non-inferiority would be a success, with superiority as potential upside. Q: How are MG and CIDP revenues growing, and what impact will ocular MG, pediatric MG, and the auto-injector have on the trajectory in 2027? A: Chief Commercialization Officer Sandrine Piret-Gerard said both indications grew well in the quarter, with no slowdown in CIDP and MG no longer the sole growth driver. The seronegative launch delivered strong access, with roughly 96% of covered lives secured and most payers removing serotype testing, plus a halo effect across the broader gMG population about 10% of seronegative prescribers were new to VYVGART. She expects a similar halo effect for pediatric and ocular MG, positioning VYVGART earlier in the treatment paradigm, and noted the magnitude of the halo effect exceeded internal expectations. Q: What additional ALKIVIA data will be presented at ACR, and what are the key considerations for the dermatomyositis trial? A: Luc Truyen said the ACR oral late-breaker presentation will contain a significant amount of efficacy data across both IMNM and DM. On DM, management said a recent sBLA meeting with the FDA provided the clarity needed and confirmed the base case, with the team designing an additional registrational study using the argenx playbook to make it as efficient as possible. Specific trial details were not disclosed. Q: How confident are you in delivering Vision 2030, and which indications will drive the 50,000-patient target? A: CEO Karen Massey said she has strong conviction in hitting Vision 2030 through multiple paths. The bulk of the 50,000 patients by 2030 is expected to come from MG and CIDP given launch timing and continued growth, with IMNM, a potential MMN approval, and other indications contributing. She noted the company is well on track for 10 labeled indications aided by five potential 2027 launches and five molecules in Phase 3 by the end of the decade, with 10 clinical-stage molecules expected by year-end 2026. Q: Does the five potential 2027 launches include Empasiprubart in MMN, and what supports priority review eligibility? A: Management confirmed the five potential US launches include MMN, assuming positive IMPASSION data in December. The company plans to apply for priority review for Empasiprubart in MMN, believing it meets the criteria given the high unmet need, though the final decision will follow the data readout. Q: What do you need to show in IMPASSION beyond the primary endpoint to drive physician adoption, and how would Empasiprubart be positioned against VYVGART in CIDP? A: Sandrine Piret-Gerard said non-inferiority versus IVIg would be a success given MMN's extreme treatment burden patients can spend up to two days in a row on infusions with once-monthly IV and eventual subcutaneous administration offering meaningful convenience. On CIDP, management said VYVGART has the highest response rates seen but some patients do not respond, reflecting disease heterogeneity; Empasiprubart enrolled all comers, and having both mechanisms should enable biomarker-driven understanding and patient segmentation, positioning argenx to lead the CIDP market. Q: What is the competitive profile of FB102 in celiac disease, and what are the plans for vitiligo and alopecia? A: Management described FB102 as a potential first-in-class and best-in-class asset, with Phase 2 celiac data showing consistent efficacy on histology and symptoms alongside a favorable safety profile. Luc Truyen said the team is designing the Phase 3 celiac plan, and for vitiligo where data are already in hand the company is determining the most efficient path to patients with authorities. A more holistic pipeline update is expected around JPMorgan in early 2027. Q: Should we assume all pivotal programs include built-in futility analyses following the Sjogren's and TED discontinuations? A: Management said the company is disciplined about embedding measures like futility analyses so it can move early, move fast, and stop early, as seen with Sjogren's. Investors should expect such mechanisms across development programs, preserving calculated risk-taking on the biology while enabling disciplined investment decisions. Q: Why did the FDA require an additional dermatomyositis trial despite the ALKIVIA data, and how long might it take? A: Luc Truyen explained that the DM endpoint was missed even though the effect size was consistent with IMNM, so the FDA viewed the data as hypothesis-generating and requiring confirmatory evidence. He declined to speculate on trial duration pending agreement with the agency but noted existing DM data will inform sizing and effect assumptions. Management added that argenx has a track record of beating industry averages on timelines and aims to move as fast as possible. Q: What drove the Sjogren's futility outcome, and does it read through to other rheumatology indications like systemic sclerosis? A: For the complete transcript of the earnings call, please refer to the full earnings call transcript.

- Results from the global Phase 3 ALKIVIA study, the first registrational study investigating an FcRn blocker in autoimmune myositis, show efgartigimod provides clinically meaningful improvements in IMNM and DM - Patient improvements observed as early as Week 4 and sustained through 52 weeks - Late-breaking oral presentation on Wednesday, November 11th, 9:15 – 9:30 AM ET October 19, 2026, 8:00 AM ET Amsterdam, the Netherlands – argenx SE (Euronext & Nasdaq: ARGX), the immunology innovation company, today announced that new data from the Phase 3 study evaluating VYVGART® Hytrulo (efgartigimod alfa and hyaluronidase-qvfc) in patients with autoimmune myositis, focused on immune-mediated necrotizing myopathy (IMNM) and dermatomyositis (DM), will be featured as a late-breaking oral presentation (#LB24) during the American College of Rheumatology (ACR) Convergence 2026 from November 6-11, 2026, in Orlando, Florida. "ALKIVIA provides the first Phase 3 evidence that precisely targeting FcRn with efgartigimod can deliver clinically meaningful benefit for patients living with autoimmune myositis, for which very few treatment options exist, and in the case of IMNM, patients have no approved treatment options at all," said Luc Truyen, M.D., Ph.D., Chief Medical Officer, argenx. "At ACR, we look forward to sharing ALKIVIA results that deepen the rheumatology community's understanding of how IgG autoantibodies drive IMNM and DM and advance our ambition to transform the treatment paradigm." In the ALKIVIA study, efgartigimod showed rapid, sustained, and clinically meaningful improvements - The Phase 3 ALKIVIA study met its primary endpoint, achieving a 15.4-point greater improvement in mean Total Improvement Score (TIS) versus placebo at Week 52 in the combined IMNM and DM population (47.95 vs. 32.56; p=0.0011). - Improvements in disease activity for the combined IMNM and DM population were observed as early as Week 4 and were sustained through the full 52 weeks of treatment, even with steroid tapering. - A greater proportion of IMNM as well as DM patients achieved a mean total improvement score of 40 or more (TIS ≥ 40) when treated with efgartigimod versus placebo. The median time to reach TIS ≥ 40 was also shorter with efgartigimod for both subtypes and was sustained through the full 52 weeks of treatment. - Efgartigimod was well-tolerated in the study. The observed safety profile of efgartigimod was consistent with prior studies and the known safety profile of efgartigimod. Details for the oral presentation are as follows: - Efgartigimod PH20 SC in Adults With Idiopathic Inflammatory Myopathy: Results From the Phase 3, Randomized, Placebo-Controlled ALKIVIA Trial, LB24 Lead Author: Dr. Rohit Aggarwal Date: Wednesday, November 11, 9:15 – 9:30 a.m. ET More information on the data presented at the ACR Convergence 2026 Annual Meeting can be found here. About the ALKIVIA study The ALKIVIA trial was a global, randomized, double-blind, placebo-controlled, multicenter, operationally seamless Phase 2/3 study of efgartigimod SC for the treatment of autoimmune myositis across IMNM, DM and PM. The ALKIVIA study randomized 265 patients who had active disease and were on background treatment. Participants were randomized (1:1) to receive weekly injections of efgartigimod PH20 SC or matched placebo PH20 SC. The study was conducted in two phases, with an analysis of the Phase 2 portion of the clinical trial after the first 89 patients completed the study, followed by 176 patients in Phase 3. In the Phase 3 study, 175 patients received treatment. The Phase 3 study included a protocol-mandated corticosteroid taper throughout the study. The primary endpoint of Phase 3 was the mean Total Improvement Score (TIS) at the end of the treatment period of 52 weeks of all treated patients compared to placebo. Prespecified analyses evaluated the combined IMNM and DM population and each subtype separately. Scored from 0-100, TIS is an ACR/EULAR-validated composite endpoint based on six core set measures, including assessment of muscle strength and function; higher TIS values reflect greater overall clinical improvement. A TIS ≥ 40 is regarded by the clinical community as the point at which noticeable improvements in muscle strength, injury and functionality are observed. ALKIVIA was conducted globally across North America, Europe, and Asia-Pacific, including China and Japan. argenx has an exclusive license agreement with Zai Lab for the development and commercialization of VYVGART and VYVGART Hytrulo in Greater China. Through this agreement, Zai Lab recruited Chinese patients into the ALKIVIA trial. About Autoimmune Myositis Autoimmune myositis is a heterogenous disease spectrum with autoimmune-mediated pathophysiology, characterized by chronic inflammation and progressive muscle weakness, and in some subtypes by skin involvement and other extramuscular manifestations. Proximal muscle weakness is a hallmark clinical feature across subtypes. Approximately 100,000 people in the United States live with autoimmune myositis, including approximately 20,000 with immune-mediated necrotizing myopathy (IMNM) and approximately 40,000 with dermatomyositis (DM). Up to 80% of patients report long-term disability despite treatment. There are currently no targeted, selective treatments available, and care and treatment relies primarily on corticosteroids and broad immunosuppressants, which are associated with significant cumulative toxicity, including metabolic, cardiovascular, musculoskeletal and infectious complications. Advances in the understanding of autoimmune myositis biology have highlighted the central role of antibody-mediated immunity, with pathogenic IgG autoantibodies contributing to muscle fiber damage and extramuscular manifestations across subtypes. About Efgartigimod and Efgartigimod SC Efgartigimod (efgartigimod alfa fcab) is a human IgG1 antibody fragment that binds to the neonatal Fc receptor (FcRn), resulting in the reduction of circulating IgG autoantibodies. It is the first approved FcRn blocker for the treatment of generalized myasthenia gravis (gMG) and chronic inflammatory demyelinating polyneuropathy (CIDP) globally, and for primary immune thrombocytopenia (ITP) in Japan. Efgartigimod SC is a subcutaneous combination of efgartigimod alfa and recombinant human hyaluronidase PH20 (rHuPH20), Halozyme's ENHANZE® drug delivery technology to facilitate subcutaneous injection delivery of biologics. About argenx argenx is the immunology innovation company, focused on turning immunology breakthroughs into medicines for patients. The company seeks novel biology wherever it emerges, co-creating with academic researchers through its Immunology Innovation Program (IIP) and investing in promising science, to develop treatments for people living with underserved diseases. By advancing molecules with the potential to reach multiple diseases and patient populations, argenx is building a world-class portfolio. This approach produced the first approved antibody fragment targeting the neonatal Fc receptor (FcRn) and today powers a growing pipeline of early and late-stage programs across several therapeutic areas. For more information, visit www.argenx.com and follow us on LinkedIn, Instagram, Facebook, and YouTube. Media: Kate Dion [email protected] Colin McBean [email protected] Investors: Alexandra Roy [email protected] FORWARD LOOKING STATEMENTS The contents of this announcement include statements that are, or may be deemed to be, "forward-looking statements." These forward-looking statements generally can be identified by the use of forward-looking words, such as "aim", "anticipate", "aspire", "believe", "can", "continue", "could", "estimate", "expect", "entail", "forecast", "future", "goals", "hope", "intend", "is designed to", "likely", "may", "might", "objective", "plan", "possible", "potential", "pursue", "project", "predict", "seek", "should", "strategy", "target", "will" and other words and terms of similar meaning and expression, including in connection with any discussion of future operating or financial performance. By their nature, forward-looking statements involve risks and uncertainties and readers are cautioned that any such forward-looking statements are not guarantees of future performance. argenx's actual results may differ materially from those predicted by the forward-looking statements as a result of various important factors, including but not limited to, the results of argenx's clinical trials; uncertainties associated with the development of novel drug therapies; preclinical and clinical trial and product development risks and setbacks; interpretation of argenx's clinical trial data by regulatory authorities and argenx's ability to obtain regulatory approval; the risk that early stage clinical trials may not be predictive of results in later stage or large scale clinical trials; the occurrence of adverse safety events or participant dropouts; the acceptance of its products and product candidates by its patients as safe, effective, and cost-effective; the impact of governmental laws and regulations, including tariffs, export controls, sanctions and other regulations on its business; the impact of healthcare regulations, including rules on reimbursement for argenx's products; competition in drug discovery, development and commercialization efforts; its reliance on third-party suppliers, service providers and manufacturers; and instability and conflicts in the regions in which the company has suppliers or markets for its products. A further list and description of these and other risks, uncertainties, and factors that could cause actual results to differ materially from those referred to in the forward-looking statements can be found in argenx's U.S. Securities and Exchange Commission (SEC) filings and reports, including in argenx's most recent annual report on Form 20-F filed with the SEC as well as subsequent filings and reports filed by argenx with the SEC. Given these risks and uncertainties, the reader is advised not to place undue reliance on such forward-looking statements. These forward-looking statements speak only as of the date of publication of this press release. argenx undertakes no obligation to publicly update or revise the information in this press release, including any forward-looking statements, except as may be required by law.

argenx's experimental CD122 inhibitor met its primary endpoint in a 126-patient study, demonstrating protection against gluten-induced intestinal damage and supporting advancement into late-stage clinical development. - argenx (NASDAQ:ARGX) reported positive Phase 2 celiac disease trial results for FB102, achieving statistical significance on the primary endpoint (p=0.0176). - The 126-patient study showed improvements in intestinal tissue measurements, with supporting inflammatory and symptom outcomes consistent with the primary findings. - No new safety signals were identified, supporting the company's decision to advance FB102 into Phase 3 development. - The results mark the first clinical readout since argenx acquired Forte Biosciences in August 2026, providing early validation of the acquired program. - FB102 has received FDA Fast Track Designation for celiac disease and is also being evaluated for vitiligo and alopecia areata. argenx has reported positive topline results from its randomized, double-blind, placebo-controlled Phase 2 FB102-301 study evaluating FB102 in adults with celiac disease. The trial met its primary endpoint, demonstrating a statistically significant improvement versus placebo in the change from baseline in the villus height-to-crypt depth ratio at day 78. This measurement assesses structural changes in the small intestine associated with gluten-induced damage, making it a relevant indicator of treatment effectiveness. The study enrolled 126 adults with confirmed celiac disease who had remained symptom-free on a strict gluten-free diet for at least 12 months. Participants received one of two intravenous FB102 dose levels or placebo while undergoing a controlled eight-week gluten challenge. According to argenx, secondary measures covering intraepithelial lymphocyte density, a composite measure of intestinal damage and inflammation, and patient symptoms were consistent with the primary endpoint. The company also reported that FB102's safety profile remained consistent with previous studies, with no additional safety concerns identified. FB102 is an investigational antibody designed to block CD122, a component of the IL-2 and IL-15 signalling pathways involved in immune-cell activation and inflammation. The treatment aims to reduce disease-driving immune activity while preserving regulatory T-cell function. argenx intends to move the program into Phase 3 clinical development, with detailed Phase 2 findings scheduled for presentation at an upcoming medical meeting. The positive Phase 2 celiac disease trial results represent an important clinical milestone for argenx's recently acquired FB102 program. The findings provide evidence that CD122 inhibition may protect intestinal tissue against gluten-induced damage, supporting the potential of a therapeutic approach targeting underlying immune mechanisms rather than relying exclusively on dietary restrictions. This is commercially relevant because celiac disease currently has no approved drug treatments, with patients dependent on maintaining a strict gluten-free diet. According to the company, approximately 1% of the global population has celiac disease, highlighting the potential patient population for an effective treatment. For argenx, the results could strengthen the strategic rationale behind its August 2026 acquisition of Forte Biosciences by advancing an acquired asset toward a pivotal development stage. The findings also provide an initial clinical basis for evaluating CD122 inhibition across additional immune-mediated conditions, although effectiveness in other diseases has not been established by this trial. From an investor perspective, the combination of a statistically significant primary endpoint, supportive secondary measures and an established safety profile may improve confidence in the program's development prospects. However, the announcement provides topline findings rather than a complete clinical dataset. Detailed efficacy results, including the magnitude of treatment effects and differences between dose groups, have not yet been disclosed. Phase 3 development will also introduce further clinical execution requirements, and the positive Phase 2 outcome does not guarantee regulatory approval. Consequently, FB102 represents a potentially important addition to argenx's immunology pipeline, but its eventual commercial contribution remains dependent on successful late-stage trials and regulatory review. The immediate focus will be the presentation of detailed Phase 2 results, particularly the size and consistency of treatment effects across the study's clinical and inflammatory measures. Investors should also monitor argenx's plans for Phase 3 development, including trial design, patient enrolment targets and expected timelines. The FDA's existing Fast Track Designation for FB102 in celiac disease provides an additional regulatory consideration as the program progresses. Further clinical updates involving vitiligo and alopecia areata could help establish whether the CD122-targeting approach has broader therapeutic applications. For argenx, the next major test will be whether the encouraging Phase 2 findings can be reproduced in a larger late-stage study and ultimately support a regulatory submission. Argenx stock price

- Study met primary endpoint of change from baseline in the ratio of Vh:Cd (p=0.0176) - First Phase 2 evidence that blocking CD122 can prevent gluten-induced intestinal damage in people living with celiac disease - argenx plans to advance FB102 into Phase 3 development October 8, 2026, 7:00 AM CET Amsterdam, the Netherlands – argenx SE (Euronext & Nasdaq: ARGX), a global immunology innovation company, today announced positive topline results from the Phase 2 study evaluating FB102, a first-in-class CD122 inhibitor, in adults with celiac disease. These results represent the first clinical readout of FB102 following argenx's acquisition of Forte Biosciences in August 2026. Patients treated with FB102 demonstrated a statistically significant and clinically relevant treatment effect compared to placebo. The study met its primary endpoint of change from baseline in the ratio of villus height–to–crypt depth (Vh:Cd) at day 78 versus placebo in adults with celiac disease undergoing a gluten challenge (p=0.0176). Broad efficacy measures, including intraepithelial lymphocyte (IEL) density, villus height-to-crypt depth intraepithelial lymphocyte (VCIEL) composite score, and symptoms, were consistent with the primary endpoint, providing additional evidence of effect across histologic, inflammatory, and clinical measures. The observed safety profile was consistent with prior studies and the known safety profile of FB102, with no new safety signals identified. "These positive Phase 2 results strengthen our conviction in the potential of FB102 to address a significant unmet need for people living with celiac disease, where there are currently no approved therapies," said Luc Truyen, M.D., Ph.D., Chief Medical Officer at argenx. "The study builds on the Phase 1b trial, providing consistent clinical evidence that CD122 blockade can protect against gluten-induced intestinal damage and prevent emergence of patient symptoms, even under a more intense gluten challenge, validating CD122 as a promising therapeutic target in celiac disease. Combined with the consistent safety profile observed across studies, these findings support advancing FB102 into Phase 3 development and further exploring its broader potential across immune-mediated diseases." Detailed results from the Phase 2 study will be shared at an upcoming medical meeting. FB102 continues to be evaluated as a potential treatment in other autoimmune diseases, including vitiligo and alopecia areata. FB102-301 Study Design FB102-301 (NCT06982963) is a randomized, double-blind, placebo-controlled, Phase 2 study evaluating FB102 in adults with celiac disease. The study enrolled 126 patients with confirmed celiac disease who were symptom free on a strict gluten-free diet for at least 12 months. Participants were randomized (2:2:1) to receive intravenous infusions of FB102 (two dose levels) or placebo while undergoing a controlled, eight-week oral gluten challenge. The primary endpoint was change from baseline in the ratio of villus height-to-crypt depth (Vh:Cd) at day 78 versus placebo, aimed at determining whether FB102 protects the intestine from gluten-induced damage over the challenge period. About Celiac Disease Celiac disease is a chronic autoimmune condition triggered by ingesting gluten, a group of proteins found in wheat, barley, and rye. In people with celiac disease, gluten triggers an immune response that damages the lining of the small intestine. Over time, this damage leads to impaired nutrient absorption and symptoms that include abdominal pain, bloating, diarrhea, and fatigue. There are no approved medicines to treat celiac disease and the current standard of care is a strict gluten-free diet. Unintended exposure to gluten through consumer products, like prepackaged foods, cosmetics, toothpaste, vitamins, and nutritional supplements, is common. Many people living with celiac disease also experience challenges eating out of the home at restaurants, work, or while traveling, which impacts their quality of life. It is estimated that approximately 1 percent of people worldwide have celiac disease, and studies show the incidence is rising by about 7.5% per year. The burden of symptoms, growing prevalence, and lack of any approved therapeutic options reinforce the critical need for medications that can address the underlying causes of intestinal damage and improve symptoms and outcomes in people living with celiac disease. About FB102 FB102 is an investigational, first-in-class anti-CD122 antibody being studied as a potential treatment for several autoimmune diseases, including celiac disease, vitiligo, and alopecia areata. CD122 is a key component of IL-2 and IL-15 signaling pathways involved in the activation and maintenance of disease-driving immune cells. FB102 is designed to block CD122 to selectively modulate IL-2 and IL-15 pathways that cause inflammation while preserving regulatory T-cell function and immune balance. The U.S. Food and Drug Administration has granted FB102 Fast Track Designation for celiac disease. About argenx argenx is a global immunology innovation company committed to improving the lives of people suffering from severe autoimmune diseases. Partnering with leading academic researchers through its Immunology Innovation Program (IIP), argenx aims to translate immunology breakthroughs into a world-class portfolio of novel antibody-based medicines. argenx developed and is commercializing the first approved neonatal Fc receptor (FcRn) blocker and is evaluating its broad potential in multiple serious autoimmune diseases while advancing several earlier stage experimental medicines within its therapeutic franchises. For more information, visit www.argenx.com and follow us on LinkedIn, Instagram, Facebook, and YouTube. This press release contains inside information within the meaning of Article 7(1) of the EU Market Abuse Regulation (Regulation 596/2014). Media: Suzanne Johnson  [email protected] Investors: Alexandra Roy [email protected] Forward Looking Statements The contents of this announcement include statements that are, or may be deemed to be, "forward-looking statements." These forward-looking statements generally can be identified by the use of forward-looking words, such as "aim", "anticipate", "aspire", "believe", "can", "continue", "could", "estimate", "expect", "entail", "forecast", "future", "goals", "hope", "intend", "is designed to", "likely", "may", "might", "objective", "plan", "possible", "potential", "pursue", "project", "predict", "seek", "should", "strategy", "target", "will" and other words and terms of similar meaning and expression, including in connection with any discussion of future operating or financial performance. By their nature, forward-looking statements involve risks and uncertainties and readers are cautioned that any such forward-looking statements are not guarantees of future performance. argenx's actual results may differ materially from those predicted by the forward-looking statements as a result of various important factors, including but not limited to, the results of argenx's clinical trials; uncertainties associated with the development of novel drug therapies; preclinical and clinical trial and product development risks and setbacks; interpretation of argenx's clinical trial data by regulatory authorities and argenx's ability to obtain regulatory approval; the risk that early stage clinical trials may not be predictive of results in later stage or large scale clinical trials; the occurrence of adverse safety events or participant dropouts; the acceptance of its products and product candidates by its patients as safe, effective, and cost-effective; the impact of governmental laws and regulations, including tariffs, export controls, sanctions and other regulations on its business; the impact of healthcare regulations, including rules on reimbursement for argenx's products; competition in drug discovery, development and commercialization efforts; its reliance on third-party suppliers, service providers and manufacturers; and instability and conflicts in the regions in which the company has suppliers or markets for its products. A further list and description of these and other risks, uncertainties, and factors that could cause actual results to differ materially from those referred to in the forward-looking statements can be found in argenx's U.S. Securities and Exchange Commission (SEC) filings and reports, including in argenx's most recent annual report on Form 20-F filed with the SEC as well as subsequent filings and reports filed by argenx with the SEC. Given these risks and uncertainties, the reader is advised not to place undue reliance on such forward-looking statements. These forward-looking statements speak only as of the date of publication of this press release. argenx undertakes no obligation to publicly update or revise the information in this press release, including any forward-looking statements, except as may be required by law.

argenx has delivered a striking share-price run over the past few years, which naturally puts the microscope on what investors are paying for its earnings today. With the stock coming off a strong multi‑year performance but some recent soft patches, the key issue is whether the current market price lines up with the profits the business is generating. Over the past 5 years, argenx shares have returned 228.2%, which raises the question of how much of that move can be explained by its earnings power rather than simply shifting sentiment. The business model depends heavily on turning its science into sustainable profit streams, so expectations around future margins and the pace at which earnings can scale will matter a lot for how today’s valuation is judged. There is a second opinion on argenx worth weighing. See what analysts think argenx's shares could be worth. For investors, the debate is whether argenx's current share price is adequately supported by the earnings the company is producing today and is expected to generate in the future. If you are evaluating argenx based on its earnings, it may be helpful to compare it with other businesses that have been screened for valuation and quality using 172 high quality undervalued stocks The P/E ratio works reasonably well for argenx because earnings are now an important part of how the market weighs its science story. The current P/E sits around 34.7x, which is close to the 35.4x peer average for similar biotechs but higher than the broader biotech industry on about 25.6x. That mix suggests investors are pricing argenx more like its direct comparison group than the typical listed biotech. The model based on the firm’s own growth profile, profitability pattern, size and risk suggests a lower P/E would be more in line with those fundamentals. On this framework, the present 34.7x level screens as overvalued rather than cheap. For a holder, the question is whether argenx can keep justifying a peer-level multiple that already sits above the wider sector, or whether a cooler earnings outlook would leave that valuation looking exposed. Explore the numbers behind argenx's P/E valuation. Simply Wall St Narratives pick up where the argenx valuation puzzle leaves off by spelling out which assumptions on growth, margins and earnings would need to hold for the stock to be worth materially more or less than today's price on the Community page. Rather than relying on a single multiple or model output, each Narrative lays out the key drivers behind its view of fair value so you can compare those expectations with the actual numbers as results come through. The community is split on argenx, with one camp arguing the current price underestimates its pipeline and deals, while the other sees execution and concentration risks as already priced in. Bull case: 8% undervalued Discover why this Narrative puts argenx at 8% undervalued. Bear case: 22% overvalued Explore why this Narrative puts argenx at 22% overvalued. Everything so far has focused on what argenx looks like today, but there is a separate layer of insight in how professional analysts sketch out the earnings profile a few years down the road. Explore where analysts expect argenx to be in a few years. This article by Simply Wall St is general in nature. We provide commentary based on historical data and analyst forecasts only using an unbiased methodology and our articles are not intended to be financial advice. It does not constitute a recommendation to buy or sell any stock, and does not take account of your objectives, or your financial situation. We aim to bring you long-term focused analysis driven by fundamental data. Note that our analysis may not factor in the latest price-sensitive company announcements or qualitative material. Simply Wall St has no position in any stocks mentioned. Companies discussed in this article include ARGX.BR. Have feedback on this article? Concerned about the content? Get in touch with us directly. Alternatively, email [email protected]

To say that Argenx (NASDAQ: ARGX) is growing is an understatement. The drugmaker has delivered an impressive 18 consecutive quarters of revenue growth. Its sales soared 60% year over year in the second quarter of 2026 and 17% sequentially. Investors have recognized Argenx's success. The biotech stock is handily beating the overall market so far this year and has more than doubled over the last three years. But is Argenx still underrated? Missed Nvidia in 2009? This Rare Signal Is Flashing Again. In 2009, a "Double Down" signal flashed for a little-known chipmaker called Nvidia. For the first time in years, that same "Total Conviction" signal is flashing for a company 1/100th the size of Nvidia. Continue » There's no secret about where Argenx's revenue growth is coming from. The company's Vyvgart and Vyvgart Hytrulo therapies continue to gain momentum in treating severe autoimmune diseases. Vyvgart is approved in the U.S. for generalized myasthenia gravis (gMG) and in Japan for the treatment of immune thrombocytopenia (ITP). Vyvgart Hytrulo combines Vyvgart with recombinant human hyaluronidase PH20, Halozyme's (NASDAQ: HALO) drug delivery technology. It's also approved for gMG and for chronic inflammatory demyelinating polyneuropathy (CIDP). But Argenx's top line is only part of the story. The company reported earnings of $472 million in Q2, nearly double its profit from the prior year period. Its operating margins are expanding. Argenx CFO Karl Gubitz recently told Reuters that rivals in the gMG market were "all behind Vyvgart." Gubitz also noted that only about 20% of gMG patients are currently receiving novel biologics, leaving Argenx with significant room for future growth. Meanwhile, the CIDP market penetration for the Vyvgart franchise is only in its early stages. Argenx recently reported a big clinical win. On Aug, 17, 2026, the company announced positive results from a late-stage study evaluating Vyvgart Hytrulo for the treatment of autoimmune myositis, an autoimmune disease that affects around 100,000 people in the U.S. Management believes this indication represents a multibillion-dollar opportunity. More good news could be right around the corner. Argenx expects to report results from its Phase 3 study of empasiprubart in the treatment of multifocal motor neuropathy (MMN) in the fourth quarter of 2026. If those results look good, the company will be well-positioned to launch its second "pipeline-in-a-product." Argenx is scheduled to make four other important announcements next year. It plans to report top-line results from a pivotal study of Vyvgart in treating ITP in the first half of 2027 and from another pivotal study in treating Sjogren's disease in the second half. The company also expects to report results from two studies evaluating empasiprubart in treating CIDP in the second half of 2027. The recent acquisition of Forte Biosciences adds another promising candidate to Argenx's pipeline, the anti-CD122 antibody FB102. Argenx expects to announce results from a Phase 2 study of the experimental therapy for celiac disease and from a Phase 1b study for alopecia areata before the end of 2026. Is Argenx underrated? The verdict is "yes," according to Wall Street. Of the 23 analysts surveyed by S&P Global (NYSE: SPGI) in August, 20 rated the stock as a "buy" or "strong buy." The other three recommended holding Argenx. The 12-month price target for the stock reflects a potential upside of roughly 14%. Sure, Argenx looks expensive, with shares trading at 37.5 times forward earnings. However, growth stocks with significant opportunities usually command premium valuations. Given Vyvgart's expansion opportunities and its promising pipeline, I agree with analysts. Despite its tremendous success, Argenx remains an underrated biotech stock. Before you buy stock in Argenx Se, consider this: The Motley Fool Stock Advisor analyst team just identified what they believe are the 10 best stocks for investors to buy now… and Argenx Se wasn’t one of them. The 10 stocks that made the cut could produce monster returns in the coming years. Consider when Netflix made this list on December 17, 2004... if you invested $1,000 at the time of our recommendation, you’d have $437,097!* Or when Nvidia made this list on April 15, 2005... if you invested $1,000 at the time of our recommendation, you’d have $1,355,077!* Now, it’s worth noting Stock Advisor’s total average return is 978% — a market-crushing outperformance compared to 213% for the S&P 500. Don't miss the latest top 10 list, available with Stock Advisor, and join an investing community built by individual investors for individual investors. See the 10 stocks » *Stock Advisor returns as of September 2, 2026. Keith Speights has no position in any of the stocks mentioned. The Motley Fool has positions in and recommends Argenx Se and S&P Global. The Motley Fool has a disclosure policy. Argenx Has Delivered 18 Consecutive Quarters of Sales Growth -- but Is the Biotech Stock Still Underrated? was originally published by The Motley Fool