DNTH

Early GO decision reached in CAPTIVATE in March 2026 based on GO criteria of 20 confirmed responders achieved with less than 40 planned participants completing open-label Part A Claseprubart granted Orphan Drug Designation by FDA for Myasthenia Gravis Phase 3 registrational trial of claseprubart evaluating 300mg/2mL Q2W and 300mg/2mL Q4W in generalized Myasthenia Gravis (gMG) on track to initiate in mid-2026; top-line results anticipated in 2H’28 Phase 2 MoMeNtum trial of claseprubart in Multifocal Motor Neuropathy (MMN) ongoing; top-line results on track for Q4’26 Phase 1 healthy volunteer data for DNTH212 anticipated in 2H’26 Building a rheumatology franchise around DNTH212 with first three priority indications of Sjögren’s Disease (SjD), Systemic Lupus Erythematosus (SLE), and Dermatomyositis (DM) Further strengthened the balance sheet with approximately $719 million in gross proceeds from an underwritten public offering of common stock and pre-funded warrants Approximately $1.2 billion of cash as of March 31, 2026 provides expected runway into 2030 NEW YORK and WALTHAM, Mass., May 05, 2026 (GLOBE NEWSWIRE) -- Dianthus Therapeutics, Inc. (Nasdaq: DNTH), a clinical-stage biotechnology company dedicated to developing next-generation therapies to transform the treatment of severe autoimmune diseases, today reported financial results for the first quarter ending March 31, 2026, and provided an update on other recent business achievements. “Q1 of this year was a pivotal period for Dianthus as we were able to make an early GO decision in PART A of the claseprubart CIDP CAPTIVATE study. In CAPTIVATE, we targeted 40 patients completing Part A and a response rate of approximately 50% based on precedent set with aC1s inhibition. We were able to make an early GO decision after 20 confirmed responders were identified with less than the 40 planned participants completing Part A. Claseprubart potency and early efficacy and safety results in CAPTIVATE Part A further build our confidence in claseprubart as a potentially best-in-disease therapy for neuromuscular diseases,” said Marino Garcia, Chief Executive Officer of Dianthus Therapeutics. “We are also excited to announce the first three priority indications selected for DNTH212, our first-in-class bifunctional fusion protein and next potential best-in-disease pipeline therapeutic: Sjögren’s Disease, Systemic Lupus Eryt...

Claseprubart achieved statistically significant and clinically meaningful improvements in Myasthenia Gravis Activities of Daily Living (MG-ADL), Quantitative Myasthenia Gravis (QMG), and other efficacy measures at Week 13 in Phase 2 MaGic trial in gMG New claseprubart data from the MaGic open-label extension supporting potential for 300mg/2mL Q4W dosing and new in vitro data highlighting potential efficacy benefits of upstream (aC1s, claseprubart) vs. downstream (C5, ravulizumab) complement inhibition were presented during the AANEM Annual Meeting in October 2025 Phase 3 gMG trial including two claseprubart treatment arms, 300mg/2mL Q2W and 300mg/2mL Q4W, vs. placebo anticipated to initiate in 2026 Accelerated timing for interim responder analysis for Phase 3 CAPTIVATE trial of claseprubart in Chronic Inflammatory Demyelinating Polyneuropathy (CIDP); now anticipated in Q2’26 (formerly 2H’26) due to faster than expected enrollment Phase 2 MoMeNtum trial of claseprubart in Multifocal Motor Neuropathy (MMN) ongoing; top-line results anticipated in 2H’26 Announced exclusive license agreement for DNTH212, a bifunctional BDCA2 and BAFF/APRIL inhibitor; Phase 1 healthy volunteer data anticipated in 2H’26 Estimated ~$525 million of cash after DNTH212 upfront and near-term milestone payments provides runway into 2028 NEW YORK and WALTHAM, Mass., Nov. 05, 2025 (GLOBE NEWSWIRE) -- Dianthus Therapeutics, Inc. (Nasdaq: DNTH), a clinical-stage biotechnology company dedicated to developing next-generation therapies to transform the treatment of severe autoimmune diseases, today reported financial results for the third quarter ending September 30, 2025, and provided an update on recent business achievements. “I’m extremely proud of our team’s outstanding track record of execution against our vision to become a leading biotech company in the I&I field. Just in the past 2 months, we delivered impressive results from the gMG MaGic trial, accelerated the timing of the interim responder analysis from our CIDP CAPTIVATE trial from 2H’26 to Q2'26, and in-licensed DNTH212, a new and exciting clinical-stage bifunctional fusion protein. Both claseprubart and DNTH212 have validated mechanisms of action with pipeline-in-a-product potential, and aim to deliver best-in-class efficacy, safety, and convenience with infrequent, subcutaneous self-administration,” said Marino Garcia, Chief Ex...

The market expects Dianthus Therapeutics, Inc. (DNTH) to deliver a year-over-year decline in earnings on lower revenues when it reports results for the quarter ended September 2025. This widely-known consensus outlook is important in assessing the company's earnings picture, but a powerful factor that might influence its near-term stock price is how the actual results compare to these estimates. The earnings report might help the stock move higher if these key numbers are better than expectations. On the other hand, if they miss, the stock may move lower. While the sustainability of the immediate price change and future earnings expectations will mostly depend on management's discussion of business conditions on the earnings call, it's worth handicapping the probability of a positive EPS surprise. This company is expected to post quarterly loss of $0.86 per share in its upcoming report, which represents a year-over-year change of -16.2%. Revenues are expected to be $0.66 million, down 69.6% from the year-ago quarter. The consensus EPS estimate for the quarter has been revised 0.62% lower over the last 30 days to the current level. This is essentially a reflection of how the covering analysts have collectively reassessed their initial estimates over this period. Investors should keep in mind that an aggregate change may not always reflect the direction of estimate revisions by each of the covering analysts. Price, Consensus and EPS Surprise Estimate revisions ahead of a company's earnings release offer clues to the business conditions for the period whose results are coming out. This insight is at the core of our proprietary surprise prediction model -- the Zacks Earnings ESP (Expected Surprise Prediction). The Zacks Earnings ESP compares the Most Accurate Estimate to the Zacks Consensus Estimate for the quarter; the Most Accurate Estimate is a more recent version of the Zacks Consensus EPS estimate. The idea here is that analysts revising their estimates right before an earnings release have the latest information, which could potentially be more accurate than what they and others contributing to the consensus had predicted earlier. Thus, a positive or negative Earnings ESP reading theoretically indicates the likely deviation of the actual earnings from the consensus estimate. However, the model's predictive power is significant for positive ESP readings onl...

NEW YORK and WALTHAM, Mass., Sept. 07, 2025 (GLOBE NEWSWIRE) -- Dianthus Therapeutics, Inc. (Nasdaq: DNTH), a clinical-stage biotechnology company dedicated to advancing the next generation of antibody complement therapeutics to treat severe autoimmune diseases, today announced a conference call and webcast to discuss results from the Phase 2 MaGic trial of claseprubart (DNTH103) in generalized Myasthenia Gravis (gMG) scheduled for tomorrow, Monday, September 8, 2025 at 8:00 a.m. EDT. Investor Webcast & Conference Call Information To access the live conference call by phone, please register here. Conference call participants in the question and answer session should pre-register to receive the dial-in number and personal PIN. A live webcast may be accessed through the Investors and Media section of the Company’s website, www.dianthustx.com. Following the call, a replay will be available at the same location. About Dianthus Therapeutics Dianthus Therapeutics is a clinical-stage biotechnology company dedicated to designing and delivering novel, best-in-class monoclonal antibodies with improved selectivity and potency. Based in New York City and Waltham, Mass., Dianthus is comprised of an experienced team of biotech and pharma executives who are leading the development of next-generation antibody complement therapeutics, aiming to deliver transformative medicines for people living with severe autoimmune and inflammatory diseases. To learn more, please visit www.dianthustx.com and follow us on LinkedIn. Contact Jennifer Davis Ruff Dianthus Therapeutics [email protected]

Phase 2 MaGic trial of claseprubart (DNTH103) in generalized Myasthenia Gravis (gMG) top-line results anticipated in September 2025; the first of three catalysts for the claseprubart neuromuscular franchise by YE’26 Phase 3 CAPTIVATE trial of claseprubart in Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) ongoing; interim responder analysis anticipated in 2H’26 Phase 2 MoMeNtum trial of claseprubart in Multifocal Motor Neuropathy (MMN) ongoing; top-line results anticipated in 2H’26 $309.1 million of cash provides runway into 2H’27 NEW YORK and WALTHAM, Mass., Aug. 07, 2025 (GLOBE NEWSWIRE) -- Dianthus Therapeutics, Inc. (Nasdaq: DNTH), a clinical-stage biotechnology company dedicated to advancing the next generation of antibody complement therapeutics to treat severe autoimmune diseases, today reported financial results for the second quarter ending June 30, 2025, and provided an update on recent business achievements. “We look forward to reporting top-line Phase 2 results from our MaGic trial with claseprubart in gMG in September. We believe the multibillion-dollar gMG market has significant potential to expand, as only approximately 10% of AChR+ patients in the U.S. are currently on FcRn or complement therapies today,” said Marino Garcia, Chief Executive Officer of Dianthus Therapeutics. “Our recently completed quantitative market research with gMG treating neurologists in the U.S. clearly highlights their desire for new, improved therapies, specifically those with greater durability of symptom control, a differentiated safety profile by eliminating the boxed warning and REMS of C5 inhibitors, and a more convenient, patient-friendly delivery like an infrequent, self-administered autoinjector. We believe claseprubart has the potential to effectively address these unmet needs and help expand the use of biologics earlier in the treatment paradigm with patients that would otherwise delay the use of more burdensome biologics.” Claseprubart (DNTH103) Clinical Development Claseprubart is an investigational, clinical-stage, potent monoclonal antibody engineered to selectively target the classical pathway by inhibiting only the active form of the C1s protein, a clinically validated complement target. Claseprubart is designed to enable a more convenient, subcutaneous, self-administered injection dosed as infrequently as once every two weeks. Claseprubart ha...

The market expects Dianthus Therapeutics, Inc. (DNTH) to deliver a year-over-year decline in earnings on lower revenues when it reports results for the quarter ended June 2025. This widely-known consensus outlook is important in assessing the company's earnings picture, but a powerful factor that might influence its near-term stock price is how the actual results compare to these estimates. The stock might move higher if these key numbers top expectations in the upcoming earnings report. On the other hand, if they miss, the stock may move lower. While management's discussion of business conditions on the earnings call will mostly determine the sustainability of the immediate price change and future earnings expectations, it's worth having a handicapping insight into the odds of a positive EPS surprise. This company is expected to post quarterly loss of $0.86 per share in its upcoming report, which represents a year-over-year change of -68.6%. Revenues are expected to be $1.24 million, down 33.3% from the year-ago quarter. The consensus EPS estimate for the quarter has been revised 0.32% higher over the last 30 days to the current level. This is essentially a reflection of how the covering analysts have collectively reassessed their initial estimates over this period. Investors should keep in mind that an aggregate change may not always reflect the direction of estimate revisions by each of the covering analysts. Price, Consensus and EPS Surprise Estimate revisions ahead of a company's earnings release offer clues to the business conditions for the period whose results are coming out. Our proprietary surprise prediction model -- the Zacks Earnings ESP (Expected Surprise Prediction) -- has this insight at its core. The Zacks Earnings ESP compares the Most Accurate Estimate to the Zacks Consensus Estimate for the quarter; the Most Accurate Estimate is a more recent version of the Zacks Consensus EPS estimate. The idea here is that analysts revising their estimates right before an earnings release have the latest information, which could potentially be more accurate than what they and others contributing to the consensus had predicted earlier. Thus, a positive or negative Earnings ESP reading theoretically indicates the likely deviation of the actual earnings from the consensus estimate. However, the model's predictive power is significant for positive ESP readi...

Completed enrollment in Phase 2 MaGic trial of DNTH103 in generalized Myasthenia Gravis (gMG) Top-line MaGic results anticipated in September 2025 to be the first of three catalysts for the DNTH103 neuromuscular franchise by YE’26 Phase 3 CAPTIVATE trial of DNTH103 in Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) ongoing; interim responder analysis anticipated in 2H’26 Phase 2 MoMeNtum trial of DNTH103 in Multifocal Motor Neuropathy (MMN) ongoing; top-line results anticipated in 2H’26 $331.5 million of cash provides runway into 2H’27 NEW YORK and WALTHAM, Mass., May 12, 2025 (GLOBE NEWSWIRE) -- Dianthus Therapeutics, Inc. (Nasdaq: DNTH), a clinical-stage biotechnology company dedicated to advancing the next generation of antibody complement therapeutics to treat severe autoimmune diseases, today reported financial results for the first quarter ending March 31, 2025, and provided an update on recent business achievements. “The first few months of 2025 represent continued excellence in execution by the Dianthus team, including the timely completion of enrollment in our Phase 2 MaGic trial of DNTH103 in gMG, and we look forward to reporting top-line results in September,” said Marino Garcia, Chief Executive Officer of Dianthus Therapeutics. “Despite currently approved biologics in the gMG market, significant opportunities remain for improved first-line treatment options. We believe that achieving DNTH103’s target profile of effective, consistent symptom control, differentiated safety, and convenient dosing and administration could position it as a preferred first-line biologic therapy across the three neuromuscular indications of gMG, CIDP and MMN.” DNTH103 Clinical Development DNTH103 is an investigational, clinical-stage, potent monoclonal antibody engineered to selectively target the classical pathway by inhibiting only the active form of the C1s protein, a clinically validated complement target. DNTH103 is designed to enable a more convenient subcutaneous, self-administered injection dosed as infrequently as once every two weeks. DNTH103 has the potential to be a best-in-class pipeline-in-a-product across a range of autoimmune disorders with high unmet need. Generalized Myasthenia Gravis (gMG) Enrollment complete in Phase 2 MaGic gMG trial: The MaGic trial is a global, randomized, double-blind, placebo-controlled Phase 2 trial in patients with gM...

MaGic trial exceeded enrollment target of 60 patients Top-line results anticipated this September will be the first of three DNTH103 catalysts by YE'26 Building a neuromuscular franchise with DNTH103 in gMG, CIDP and MMN with a potential best-in-class, potent classical pathway inhibitor intended as a self-administered autoinjector dosed once every two weeks NEW YORK and WALTHAM, Mass., May 05, 2025 (GLOBE NEWSWIRE) -- Dianthus Therapeutics, Inc. (Nasdaq: DNTH), a clinical-stage biotechnology company dedicated to advancing the next generation of antibody complement therapeutics to treat severe autoimmune diseases, today announced completion of enrollment in the Phase 2 MaGic trial of DNTH103 in patients with generalized Myasthenia Gravis (gMG). DNTH103 is an investigational, clinical-stage, potent monoclonal antibody engineered to selectively target the classical pathway by inhibiting only the active form of the C1s protein. Initial top-line results from the MaGic trial are anticipated in September 2025. MaGic is a global, randomized, double-blind, placebo-controlled Phase 2 trial that enrolled 65 patients with acetylcholine receptor (AChR) antibody positive gMG, exceeding the enrollment target of 60 patients. The primary endpoint of the trial is safety and tolerability, and key secondary endpoints include Myasthenia Gravis Activities of Daily Living Scale (MG-ADL) and Quantitative Myasthenia Gravis (QMG) score assessments. “We are pleased to have reached this important milestone in the development of DNTH103 for gMG, which is well understood to be a classical pathway-driven disease,” said Marino Garcia, Chief Executive Officer of Dianthus Therapeutics. “Latest estimates indicate that the gMG market in the U.S. exceeds 100,000 patients, approximately 85% of whom have AChR autoantibody-driven disease, with growing first-line biologic use. Despite currently approved treatment options, a significant unmet need exists for patients seeking continuous symptom control, lower risk for infections, and more convenient dosing and administration, which we believe DNTH103 has the potential to address as a first-line therapy.” DNTH103 is an investigational, clinical-stage, potent monoclonal antibody engineered to selectively target the classical pathway by inhibiting only the active form of the C1s protein, a clinically validated complement target. DNTH103 is designed to e...

Net loss: US$85.0m (loss widened by 95% from FY 2023). US$2.55 loss per share. Phase II: 2. Phase III: 1. All figures shown in the chart above are for the trailing 12 month (TTM) period Revenue exceeded analyst estimates by 15%. Earnings per share (EPS) also surpassed analyst estimates by 3.1%. In the last 12 months, the only revenue segment was Biotechnology (Startups) contributing US$6.24m. The largest operating expense was Research & Development (R&D) costs, amounting to US$83.1m (77% of total expenses). Over the last 12 months, the company's earnings were enhanced by non-operating gains of US$16.9m. Explore how DNTH's revenue and expenses shape its earnings. Looking ahead, revenue is forecast to grow 69% p.a. on average during the next 3 years, compared to a 20% growth forecast for the Biotechs industry in the US. Performance of the American Biotechs industry. The company's shares are down 3.8% from a week ago. It is worth noting though that we have found 3 warning signs for Dianthus Therapeutics (1 is a bit unpleasant!) that you need to take into consideration. Have feedback on this article? Concerned about the content? Get in touch with us directly. Alternatively, email editorial-team (at) simplywallst.com.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.

Phase 2 MaGic trial of DNTH103 in generalized Myasthenia Gravis (gMG) ongoing; top-line results on track for 2H’25 Phase 3 CAPTIVATE trial of DNTH103 in Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) ongoing; interim responder analysis anticipated in 2H’26 Phase 2 MoMeNtum trial of DNTH103 in Multifocal Motor Neuropathy (MMN) ongoing; top-line results anticipated in 2H’26 $357.0 million of cash provides runway into 2H’27 NEW YORK and WALTHAM, Mass., March 11, 2025 (GLOBE NEWSWIRE) -- Dianthus Therapeutics, Inc. (Nasdaq: DNTH), a clinical-stage biotechnology company dedicated to advancing the next generation of antibody complement therapeutics to treat severe autoimmune diseases, today reported financial results for the fourth quarter and full year ending December 31, 2024 and provided an update on recent business achievements. “We remain on track to report top-line data in 2H’25 from our Phase 2 clinical trial of DNTH103 in gMG, an indication where a best-in-class, potent active C1s and classical pathway inhibitor with the potential for effective and consistent symptom control along with improved safety and convenience could meaningfully advance the standard of care,” said Marino Garcia, Chief Executive Officer of Dianthus Therapeutics. “We are excited to have initiated our pivotal Phase 3 CAPTIVATE trial in CIDP, which is on track for an interim responder analysis in 2H’26, along with top-line results from our Phase 2 trial in MMN.” DNTH103 Clinical Development DNTH103 is an investigational, clinical-stage, potent monoclonal antibody engineered to selectively target the classical pathway by inhibiting only the active form of the C1s protein, a clinically validated complement target. DNTH103 is enhanced with YTE half-life extension technology designed to enable a more convenient subcutaneous, self-administered injection dosed as infrequently as once every two weeks. DNTH103 has the potential to be a best-in-class pipeline-in-a-product across a range of autoimmune disorders with high unmet need. Generalized Myasthenia Gravis (gMG) Phase 2 MaGic gMG trial ongoing: The MaGic trial is a global, randomized, double-blind, placebo-controlled Phase 2 trial in patients with gMG who are acetylcholine receptor (AChR) antibody positive, and it remains on track to report top-line results in 2H’25. Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) Phase 3...