VRDN
Viridian TherapeuticsBDocument history
Earnings documents stored for VRDN.
Investor releaseQuarter not tagged2026-08-06Viridian Therapeutics Highlights Recent Business Progress and Reports Second Quarter 2026 Financial Results
Business Wire
Viridian Therapeutics Highlights Recent Business Progress and Reports Second Quarter 2026 Financial Results
- Lumvoa™ (veligrotug-vvze) approved by the FDA for thyroid eye disease (TED) on June 26, 2026, ahead of target PDUFA date and immediately launched in the U.S. - - Elegrobart, potentially the first subcutaneous autoinjector for the treatment of TED, on track for BLA submission Q1 2027 - - Pipeline progress continues, with FcRn and TSHR program development milestones on track in 2026 - - Completed convertible debt and equity financing in May 2026 with gross proceeds of $394 million; cash, cash equivalents, and marketable securities of $982 million as of June 30, 2026 - WALTHAM, Mass., August 06, 2026--(BUSINESS WIRE)--Viridian Therapeutics, Inc. (Nasdaq: VRDN), a biotechnology company focused on discovering, developing, and commercializing potentially best-in-class medicines for autoimmune and rare diseases, today reported recent business highlights and financial results for the second quarter ended June 30, 2026. "We are very encouraged by the early indications from our recent launch of Lumvoa as we start a new chapter for Viridian as a commercial-stage company," said Steve Mahoney, President and Chief Executive Officer of Viridian Therapeutics. "Our team’s focus on execution continues in the commercial setting and we are happy with the early launch feedback from physicians and patients, positive payer engagement, and our progress in building enthusiasm for Lumvoa as a new treatment option. In parallel, we continue to advance our R&D pipeline toward a planned BLA submission for elegrobart in the first quarter of 2027, and are on track to deliver on clinical development milestones for our FcRn and TSHR programs in the second half of this year. With a strong balance sheet, we are well positioned to continue executing across our commercial and development priorities." Recent Business Highlights TED PORTFOLIO Lumvoa: commercial launch in the U.S. with strong early momentum Elegrobart (VRDN-003): BLA submission on track for Q1 2027 TSHR program: IND submission anticipated in Q4 2026 FCRN PORTFOLIO VRDN-008: phase 1 healthy volunteer data expected in 2H 2026 VRDN-006: development plan on track for disclosure in 2026 Financial Results Cash Position: Cash, cash equivalents, and marketable securities were $981.5 million as of June 30, 2026, compared with $762.2 million as of March 31, 2026. Existing cash and anticipated future commercial revenues from Lumvoa and eleg…Read full documentShow less
- Lumvoa™ (veligrotug-vvze) approved by the FDA for thyroid eye disease (TED) on June 26, 2026, ahead of target PDUFA date and immediately launched in the U.S. - - Elegrobart, potentially the first subcutaneous autoinjector for the treatment of TED, on track for BLA submission Q1 2027 - - Pipeline progress continues, with FcRn and TSHR program development milestones on track in 2026 - - Completed convertible debt and equity financing in May 2026 with gross proceeds of $394 million; cash, cash equivalents, and marketable securities of $982 million as of June 30, 2026 - WALTHAM, Mass., August 06, 2026--(BUSINESS WIRE)--Viridian Therapeutics, Inc. (Nasdaq: VRDN), a biotechnology company focused on discovering, developing, and commercializing potentially best-in-class medicines for autoimmune and rare diseases, today reported recent business highlights and financial results for the second quarter ended June 30, 2026. "We are very encouraged by the early indications from our recent launch of Lumvoa as we start a new chapter for Viridian as a commercial-stage company," said Steve Mahoney, President and Chief Executive Officer of Viridian Therapeutics. "Our team’s focus on execution continues in the commercial setting and we are happy with the early launch feedback from physicians and patients, positive payer engagement, and our progress in building enthusiasm for Lumvoa as a new treatment option. In parallel, we continue to advance our R&D pipeline toward a planned BLA submission for elegrobart in the first quarter of 2027, and are on track to deliver on clinical development milestones for our FcRn and TSHR programs in the second half of this year. With a strong balance sheet, we are well positioned to continue executing across our commercial and development priorities." Recent Business Highlights TED PORTFOLIO Lumvoa: commercial launch in the U.S. with strong early momentum Elegrobart (VRDN-003): BLA submission on track for Q1 2027 TSHR program: IND submission anticipated in Q4 2026 FCRN PORTFOLIO VRDN-008: phase 1 healthy volunteer data expected in 2H 2026 VRDN-006: development plan on track for disclosure in 2026 Financial Results Cash Position: Cash, cash equivalents, and marketable securities were $981.5 million as of June 30, 2026, compared with $762.2 million as of March 31, 2026. Existing cash and anticipated future commercial revenues from Lumvoa and elegrobart, if approved, are expected to fund Viridian’s current business plans through profitability. R&D Expenses: Research and development expenses were $71.6 million for the three months ended June 30, 2026, compared to $86.6 million for the three months ended June 30, 2025. The decrease in research and development expenses was driven by reduced expenses related to veligrotug and elegrobart studies, partially offset by additional investment in advancing our TSHR program, as well as increased personnel-related costs as a result of headcount increases. SG&A Expenses: Selling, general and administrative expenses for the three months ended June 30, 2026 were $55.0 million, compared with $20.2 million for the three months ended June 30, 2025. The increase in selling, general and administrative expenses was driven by increased personnel-related costs and build-out of commercial infrastructure for Lumvoa. Net Loss: Net loss for the three months ended June 30, 2026, was $127.1 million, compared with $100.7 million for the three months ended June 30, 2025. Shares Outstanding: As of June 30, 2026, Viridian had 125,349,092 shares of common stock outstanding on an as-converted basis, which included 113,238,218 shares of common stock and an aggregate 12,110,874 shares of common stock issuable upon the conversion of 181,654 total shares of preferred stock. About Viridian Therapeutics Viridian Therapeutics is a biotechnology company dedicated to developing better medicines for patients with autoimmune and rare diseases. Utilizing our expertise in antibody discovery and protein engineering, we aim to build on proven science to develop innovative medicines that address unmet needs and improve patient outcomes. With an immediate focus in thyroid eye disease (TED), we developed Lumvoa, a full IGF-1R antagonist approved by the U.S. FDA for the treatment of thyroid eye disease. We are also advancing elegrobart, a late-stage investigational subcutaneous therapy designed to further address unmet needs in TED and improve patient convenience. Beyond TED, we are advancing a pipeline of potential best-in-class medicines to address multiple serious autoimmune diseases. Viridian is headquartered in Waltham, Massachusetts. For more information, please visit www.viridiantherapeutics.com. Follow Viridian on LinkedIn and X. Forward Looking Statements This press release contains forward-looking statements. These statements may be identified by the use of words such as, but not limited to, "anticipate," "believe," "become," "continue," "could," "design," "estimate," "expect," "intend," "may," "might," "on track," "plan," "potential," "predict," "project," "should," "target," "will," or "would" or other similar terms or expressions that concern our expectations, plans and intentions. Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based on our current beliefs, expectations, and assumptions. Forward-looking statements include, without limitation, statements regarding: the commercialization of Lumvoa, including early indications of launch; that the company’s current commercial and medical affairs infrastructure will support and accelerate an elegrobart launch; preclinical development, clinical development, and anticipated commercialization of Viridian’s product candidates, elegrobart, VRDN-006, and VRDN-008, including the company’s intention to communicate development plans for VRDN-006 in 2026; anticipated data results and timing of their disclosure, including VRDN-008 phase 1 healthy volunteer data expected in the second half of 2026; Viridian’s expectations regarding the anticipated timing or likelihood of regulatory submissions and approvals, including a BLA submission for elegrobart in the first quarter of 2027 and an IND submission for the company’s TSHR program in the fourth quarter of 2026; elegrobart’s potential to be the first subcutaneous therapy for the treatment of TED with a planned low-volume autoinjector that patients can self-administer at home; Viridian’s product candidates potentially being best-in-class; Viridian’s expectations regarding the potential commercialization, market size, and market opportunities of veligrotug and elegrobart, if approved; and that Viridian’s cash and anticipated commercial revenues from Lumvoa and, if approved, elegrobart, will be sufficient to fund its business plans through profitability. New risks and uncertainties may emerge from time to time, and it is not possible to predict all risks and uncertainties. No representations or warranties (expressed or implied) are made about the accuracy of any such forward-looking statements. Such forward-looking statements are subject to a number of material risks and uncertainties including but not limited to: that the company has historically incurred losses and may not be able to secure additional capital when needed; that prior to marketing approval of veligrotug, the company had not generated revenue from product sales; that the company may be unable to maintain commercial manufacturing, sales and marketing capabilities or enter into agreements with third parties to commercially manufacture, market and sell veligrotug; market acceptance of veligrotug; potential utility, efficacy, potency, safety, clinical benefits, clinical response, and convenience of veligrotug and Viridian’s product candidates; that results or data from completed or ongoing clinical trials may not be representative of the results of ongoing or future clinical trials; that preliminary data may not be representative of final data; the timing, progress and plans for our ongoing or future research, preclinical, and clinical development programs; changes to trial protocols for ongoing or new clinical trials; expectations and changes regarding the timing for regulatory filings; regulatory interactions; expectations and changes regarding the timing for enrollment and data; uncertainty and potential delays related to clinical drug development; the duration and impact of regulatory delays in our clinical programs; the timing of and our ability to obtain and maintain regulatory approvals for our therapeutic candidates; manufacturing risks; competition from other therapies or products; estimates of market size and market opportunity; other matters that could affect the sufficiency of existing cash, cash equivalents, and short-term investments to fund operations; our financial position; our future operating results and financial performance; Viridian’s intellectual property position; the timing of preclinical and clinical trial activities and reporting results from same; that our product candidates may not be commercially successful, if approved; and other risks described from time to time in the "Risk Factors" section of our filings with the Securities and Exchange Commission, including those described in our most recent Annual Report on Form 10-K or Quarterly Report on Form 10-Q, as applicable, and supplemented from time to time by our Current Reports on Form 8-K. Any forward-looking statement speaks only as of the date on which it was made. Neither the company, nor its affiliates, advisors, or representatives, undertake any obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise, except as required by law. These forward-looking statements should not be relied upon as representing the company's views as of any date subsequent to the date hereof. View source version on businesswire.com: https://www.businesswire.com/news/home/20260806919095/en/ Contacts Investors Greg [email protected] Media Lisa [email protected]
Investor releaseQuarter not tagged2026-05-08Earnings Update: Viridian Therapeutics, Inc. (NASDAQ:VRDN) Just Reported And Analysts Are Boosting Their Estimates
Simply Wall St.
Earnings Update: Viridian Therapeutics, Inc. (NASDAQ:VRDN) Just Reported And Analysts Are Boosting Their Estimates
A week ago, Viridian Therapeutics, Inc. (NASDAQ:VRDN) came out with a strong set of first-quarter numbers that could potentially lead to a re-rate of the stock. Revenues of US$141k beat estimates by a substantial 408% margin. Unfortunately, Viridian Therapeutics also reported a statutory loss of US$0.90 per share, which at least was smaller than the analysts expected. Following the result, the analysts have updated their earnings model, and it would be good to know whether they think there's been a strong change in the company's prospects, or if it's business as usual. With this in mind, we've gathered the latest statutory forecasts to see what the analysts are expecting for next year. We've found 21 US stocks that are forecast to pay a dividend yield of over 6% next year. See the full list for free. After the latest results, the 14 analysts covering Viridian Therapeutics are now predicting revenues of US$78.4m in 2026. If met, this would reflect a notable 11% improvement in revenue compared to the last 12 months. Losses are forecast to balloon 33% to US$3.90 per share. Before this latest report, the consensus had been expecting revenues of US$58.4m and US$4.03 per share in losses. We can see there's definitely been a change in sentiment in this update, with the analysts administering a sizeable upgrade to this year's revenue estimates, while at the same time reducing their loss estimates. See our latest analysis for Viridian Therapeutics There was no major change to the consensus price target of US$34.31, perhaps suggesting that the analysts remain concerned about ongoing losses despite the improved earnings and revenue outlook. There's another way to think about price targets though, and that's to look at the range of price targets put forward by analysts, because a wide range of estimates could suggest a diverse view on possible outcomes for the business. Currently, the most bullish analyst values Viridian Therapeutics at US$50.00 per share, while the most bearish prices it at US$20.00. This is a fairly broad spread of estimates, suggesting that analysts are forecasting a wide range of possible outcomes for the business. These estimates are interesting, but it can be useful to paint some more broad strokes when seeing how forecasts compare, both to the Viridian Therapeutics' past performance and to peers in the same industry. It's pretty clear that there…Read full documentShow less
A week ago, Viridian Therapeutics, Inc. (NASDAQ:VRDN) came out with a strong set of first-quarter numbers that could potentially lead to a re-rate of the stock. Revenues of US$141k beat estimates by a substantial 408% margin. Unfortunately, Viridian Therapeutics also reported a statutory loss of US$0.90 per share, which at least was smaller than the analysts expected. Following the result, the analysts have updated their earnings model, and it would be good to know whether they think there's been a strong change in the company's prospects, or if it's business as usual. With this in mind, we've gathered the latest statutory forecasts to see what the analysts are expecting for next year. We've found 21 US stocks that are forecast to pay a dividend yield of over 6% next year. See the full list for free. After the latest results, the 14 analysts covering Viridian Therapeutics are now predicting revenues of US$78.4m in 2026. If met, this would reflect a notable 11% improvement in revenue compared to the last 12 months. Losses are forecast to balloon 33% to US$3.90 per share. Before this latest report, the consensus had been expecting revenues of US$58.4m and US$4.03 per share in losses. We can see there's definitely been a change in sentiment in this update, with the analysts administering a sizeable upgrade to this year's revenue estimates, while at the same time reducing their loss estimates. See our latest analysis for Viridian Therapeutics There was no major change to the consensus price target of US$34.31, perhaps suggesting that the analysts remain concerned about ongoing losses despite the improved earnings and revenue outlook. There's another way to think about price targets though, and that's to look at the range of price targets put forward by analysts, because a wide range of estimates could suggest a diverse view on possible outcomes for the business. Currently, the most bullish analyst values Viridian Therapeutics at US$50.00 per share, while the most bearish prices it at US$20.00. This is a fairly broad spread of estimates, suggesting that analysts are forecasting a wide range of possible outcomes for the business. These estimates are interesting, but it can be useful to paint some more broad strokes when seeing how forecasts compare, both to the Viridian Therapeutics' past performance and to peers in the same industry. It's pretty clear that there is an expectation that Viridian Therapeutics' revenue growth will slow down substantially, with revenues to the end of 2026 expected to display 14% growth on an annualised basis. This is compared to a historical growth rate of 84% over the past five years. By way of comparison, the other companies in this industry with analyst coverage are forecast to grow their revenue at 21% per year. Factoring in the forecast slowdown in growth, it seems obvious that Viridian Therapeutics is also expected to grow slower than other industry participants. The most important thing to take away is that the analysts reconfirmed their loss per share estimates for next year. They also upgraded their revenue estimates for next year, even though it is expected to grow slower than the wider industry. There was no real change to the consensus price target, suggesting that the intrinsic value of the business has not undergone any major changes with the latest estimates. With that said, the long-term trajectory of the company's earnings is a lot more important than next year. We have estimates - from multiple Viridian Therapeutics analysts - going out to 2028, and you can see them free on our platform here. Even so, be aware that Viridian Therapeutics is showing 3 warning signs in our investment analysis , and 1 of those is potentially serious... 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.
Investor releaseQuarter not tagged2026-05-05Viridian Therapeutics Reports First Quarter 2026 Financial Results and Highlights Recent Progress
Business Wire
Viridian Therapeutics Reports First Quarter 2026 Financial Results and Highlights Recent Progress
- PDUFA target action date of June 30, 2026 for veligrotug in thyroid eye disease (TED); organization is launch-ready - - Marketing Authorization Application (MAA) for veligrotug in TED submitted to the European Medicines Agency (EMA) in January 2026 and accepted for review in February 2026 - - Subcutaneous elegrobart showed positive topline data in REVEAL-1 and REVEAL-2 phase 3 clinical trials in active and chronic TED, respectively; Biologics License Application (BLA) submission anticipated in Q1 2027 with the potential to be the first subcutaneous autoinjector treatment for TED - - FcRn portfolio on track to share VRDN-006 development plan in 2026, and for VRDN-008 phase 1 healthy volunteer data 2H 2026 - - Cash, cash equivalents, and short-term investments of $762M as of March 31, 2026 - WALTHAM, Mass., May 05, 2026--(BUSINESS WIRE)--Viridian Therapeutics, Inc. (Nasdaq: VRDN), a biotechnology company focused on discovering, developing, and commercializing potentially best-in-class medicines for autoimmune and rare diseases, today reported recent business highlights and financial results for the first quarter ended March 31, 2026. "Our team continues its strong execution across our portfolio as we are launch ready ahead of veligrotug’s PDUFA target date. We delivered positive topline data from both of elegrobart’s pivotal REVEAL phase 3 clinical trials, and earlier programs are moving ahead as planned," said Steve Mahoney, President and Chief Executive Officer of Viridian Therapeutics. "With veligrotug’s PDUFA target date next month, we have hired and deployed our full field teams, readied commercial supply and supply chain infrastructure, and continue to engage physicians, payers, and key opinion leaders. We believe we are well-prepared and well-positioned to deliver a successful launch. With the positive topline data from REVEAL-1 and REVEAL-2, in active and chronic TED, respectively, we believe that subcutaneous elegrobart has the potential to be the simplest and most convenient treatment for TED." Recent Business Highlights TED PORTFOLIO Veligrotug: PDUFA target action date of June 30, 2026; ready to launch The veligrotug BLA is under Priority Review at the U.S. Food and Drug Administration (FDA) with a Prescription Drug User Fee Act (PDUFA) target action date of June 30, 2026. Veligrotug received Breakthrough Therapy Designation and Priority Review f…Read full documentShow less
- PDUFA target action date of June 30, 2026 for veligrotug in thyroid eye disease (TED); organization is launch-ready - - Marketing Authorization Application (MAA) for veligrotug in TED submitted to the European Medicines Agency (EMA) in January 2026 and accepted for review in February 2026 - - Subcutaneous elegrobart showed positive topline data in REVEAL-1 and REVEAL-2 phase 3 clinical trials in active and chronic TED, respectively; Biologics License Application (BLA) submission anticipated in Q1 2027 with the potential to be the first subcutaneous autoinjector treatment for TED - - FcRn portfolio on track to share VRDN-006 development plan in 2026, and for VRDN-008 phase 1 healthy volunteer data 2H 2026 - - Cash, cash equivalents, and short-term investments of $762M as of March 31, 2026 - WALTHAM, Mass., May 05, 2026--(BUSINESS WIRE)--Viridian Therapeutics, Inc. (Nasdaq: VRDN), a biotechnology company focused on discovering, developing, and commercializing potentially best-in-class medicines for autoimmune and rare diseases, today reported recent business highlights and financial results for the first quarter ended March 31, 2026. "Our team continues its strong execution across our portfolio as we are launch ready ahead of veligrotug’s PDUFA target date. We delivered positive topline data from both of elegrobart’s pivotal REVEAL phase 3 clinical trials, and earlier programs are moving ahead as planned," said Steve Mahoney, President and Chief Executive Officer of Viridian Therapeutics. "With veligrotug’s PDUFA target date next month, we have hired and deployed our full field teams, readied commercial supply and supply chain infrastructure, and continue to engage physicians, payers, and key opinion leaders. We believe we are well-prepared and well-positioned to deliver a successful launch. With the positive topline data from REVEAL-1 and REVEAL-2, in active and chronic TED, respectively, we believe that subcutaneous elegrobart has the potential to be the simplest and most convenient treatment for TED." Recent Business Highlights TED PORTFOLIO Veligrotug: PDUFA target action date of June 30, 2026; ready to launch The veligrotug BLA is under Priority Review at the U.S. Food and Drug Administration (FDA) with a Prescription Drug User Fee Act (PDUFA) target action date of June 30, 2026. Veligrotug received Breakthrough Therapy Designation and Priority Review from the FDA in 2025. Field team hiring, including sales, market access, and patient services, are complete and ready for launch. Commercial supply and manufacturing, distribution, and supply chain infrastructure are also established and ready for launch. Submitted an MAA to the EMA in January 2026, which was accepted for review in February 2026. Veligrotug was designed to offer a differentiated clinical profile compared to the current approved treatment option. Across pivotal trials in active and chronic TED, following five infusions, veligrotug demonstrated rapid onset of treatment effect, clinically meaningful improvements in proptosis and diplopia, durable responses, and was generally well-tolerated. Elegrobart (VRDN-003): positive pivotal phase 3 data and potential to be first subcutaneous autoinjector treatment in TED Announced positive topline data in both REVEAL-1 and REVEAL-2, elegrobart’s two pivotal phase 3 clinical trials for active and chronic TED, respectively. Elegrobart is the only subcutaneous program to demonstrate positive pivotal phase 3 clinical data in both active and chronic TED. REVEAL-1 in Active TED: met its primary endpoint with a highly statistically significant treatment effect. Both elegrobart Q4W and Q8W treatment arms showed rapid onset of treatment effect and achieved clinically meaningful 54% and 63% proptosis responder rates, respectively, versus 18% placebo at week 24. The Q4W treatment arm additionally provided meaningful diplopia benefit to patients with active TED. REVEAL-2 in Chronic TED: met its primary endpoint with a highly statistically significant treatment effect. Both elegrobart Q4W and Q8W treatment arms achieved statistically significant and clinically meaningful 50% and 54% proptosis responder rates, respectively, versus 15% placebo at week 24. The Q4W treatment arm additionally provided meaningful diplopia benefit to patients with chronic TED. Generally Well-Tolerated: Elegrobart was generally well-tolerated in both pivotal clinical trials, with low rates of hearing impairment. Viridian plans to submit a BLA to the FDA in Q1 2027 and seek approval for both Q4W and Q8W elegrobart dosing regimens. Viridian plans to launch elegrobart as the first simple and convenient autoinjector that patients can administer at home. Viridian anticipates that the veligrotug commercial and medical affairs infrastructure will support the potential elegrobart launch, if approved. TSHR program: IND submission anticipated in Q4 2026 Developing a potential best-in-class, half-life extended, monoclonal anti-thyroid-stimulating hormone receptor (TSHR) antibody, designed for subcutaneous delivery in an autoinjector with the potential to support extended dosing intervals for patient convenience. Viridian plans to submit an Investigational New Drug (IND) application in Q4 2026. Viridian expects this program to have clinical potential in TED and Graves’ disease. FCRN INHIBITOR PORTFOLIO VRDN-006: development plan expected in 2026 Viridian anticipates sharing development plans for VRDN-006 in 2026. VRDN-006 showed IgG reductions consistent with the FcRn inhibitor class in a phase 1 healthy volunteer clinical trial in 2025. VRDN-006 also spared albumin and LDL in the phase 1 clinical trial, and was generally well-tolerated. VRDN-008: phase 1 healthy volunteer clinical trial ongoing; data on track for 2H 2026 VRDN-008 IND was accepted by the FDA in January 2026, and Viridian initiated a phase 1 clinical trial in healthy volunteers which is ongoing. Data is on track for 2H 2026. VRDN-008 is a bi-specific half-life extended FcRn inhibitor. As previously disclosed, after a single, high-dose head-to-head study in non-human primates, VRDN-008 showed a longer half-life and more sustained IgG reduction versus efgartigimod. Financial Results Cash Position: Cash, cash equivalents, and marketable securities were $762.2 million as of March 31, 2026, compared with $874.7 million as of December 31, 2025. R&D Expenses: Research and development expenses for the three months ended March 31, 2026 were $77.6 million, compared to $76.8 million during the three months ended March 31, 2025. The increase in research and development expenses was driven by increased costs associated with ongoing manufacturing activities to support our preparatory commercial activities for veligrotug, additional investment in advancing our TSHR program, as well as increased personnel-related costs as a result of headcount increases; partially offset by a decrease in clinical trial costs for our TED portfolio. SG&A Expenses: Selling, general and administrative expenses for the three months ended March 31, 2026 were $38.7 million, compared with $17.1 million for the three months ended March 31, 2025. The increase in selling, general and administrative expenses was driven by preparatory commercial activities for veligrotug, including increased personnel-related costs as a result of headcount increases. Net Loss: Net loss for the three months ended March 31, 2026 was $104.9 million, compared with $86.9 million for the same period in 2025. Shares Outstanding: As of March 31, 2026, Viridian had 116,757,742 shares of common stock outstanding on an as-converted basis, which included 102,458,094 shares of common stock and an aggregate 14,299,648 shares of common stock issuable upon the conversion of 134,864 and 79,620 shares of Series A and Series B preferred stock, respectively. Upcoming Investor Conferences Viridian will participate in the following upcoming investor conferences. Live webcasts of the presentations can be accessed under "Events and Presentations" on the Investors section of the Viridian website at viridiantherapeutics.com. Replays of the webcasts will be available following each event. Jefferies Global Health Care Conference: Fireside chat on Thursday, June 4, 2026, at 9:55am ET in New York, NY Goldman Sachs 47th Annual Global Healthcare Conference: Fireside chat on Tuesday, June 9, 2026, at 4:00pm ET in Miami, FL About Viridian Therapeutics Viridian is a biotechnology company focused on discovering, developing, and commercializing potential best-in-class medicines for patients with autoimmune and rare diseases. Viridian’s expertise in antibody discovery and protein engineering enables the development of differentiated therapeutic candidates for validated drug targets and disease-driving mechanisms in autoimmune and rare diseases. Viridian is advancing multiple late-stage, anti-insulin-like growth factor-1 receptor (IGF-1R) candidates in the clinic for the treatment of patients with thyroid eye disease (TED). The company conducted a pivotal program for veligrotug, including two global phase 3 clinical trials, THRIVE and THRIVE-2, to evaluate its efficacy and safety in patients with active and chronic TED. THRIVE and THRIVE-2 reported positive topline data, meeting their primary endpoints and all secondary endpoints. Viridian is also advancing elegrobart as the potential first subcutaneous autoinjector for the treatment of TED. Viridian is conducting an ongoing pivotal program for elegrobart, including two global phase 3 pivotal clinical trials, REVEAL-1 and REVEAL-2, to evaluate the efficacy and safety of elegrobart in patients with active and chronic TED. REVEAL-1 and REVEAL-2 reported positive topline data, meeting their primary endpoints and multiple secondary endpoints. In addition to its IGF-1R inhibitor portfolio, Viridian is developing an anti–thyroid-stimulating hormone receptor (TSHR) program designed as a potential therapy for TED and Graves’ disease. Viridian is also advancing a novel portfolio of neonatal Fc receptor (FcRn) inhibitors, including VRDN-006 and VRDN-008, which have the potential to be developed in multiple autoimmune diseases. Viridian is based in Waltham, Massachusetts. For more information, please visit www.viridiantherapeutics.com. Follow Viridian on LinkedIn and X. Forward Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of words such as, but not limited to, "anticipate," "believe," "become," "continue," "could," "design," "estimate," "expect," "intend," "may," "might," "on track," "plan," "potential," "predict," "project," "should," "target," "will," or "would" or other similar terms or expressions that concern our expectations, plans and intentions. Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based on our current beliefs, expectations, and assumptions. Forward-looking statements include, without limitation, statements regarding: preclinical development, clinical development, and anticipated commercialization of Viridian’s product candidates veligrotug, elegrobart, VRDN-006, and VRDN-008, including the VRDN-008 phase 1 clinical trial; anticipated data results and timing of their disclosure, including data from the VRDN-008 phase 1 clinical trial; Viridian’s expectations regarding the anticipated timing or likelihood of regulatory submissions and approvals, including the anticipated approval of the BLA and MAA for veligrotug, submission of a BLA for elegrobart in Q1 2027, and submission of an IND for the Company’s TSHR program in Q4 2026; the impact of Breakthrough Therapy Designation, and the impact of Priority Review, including the potential commercial launch of veligrotug, if approved; the potential utility, efficacy, potency, safety, clinical benefits, clinical response, convenience, and number of indications of veligrotug, elegrobart, VRDN-006, and VRDN-008; elegrobart’s potential to be the first subcutaneous therapy for the treatment of TED; the Company’s anticipated development plans for VRDN-006 to be announced in 2026; potential disease indications for the Company’s TSHR program; and Viridian’s product candidates potentially being best-in-class. New risks and uncertainties may emerge from time to time, and it is not possible to predict all risks and uncertainties. No representations or warranties (expressed or implied) are made about the accuracy of any such forward-looking statements. Such forward-looking statements are subject to a number of material risks and uncertainties including but not limited to: potential utility, efficacy, potency, safety, clinical benefits, clinical response, and convenience of Viridian’s product candidates; that results or data from completed or ongoing clinical trials may not be representative of the results of ongoing or future clinical trials; that preliminary data may not be representative of final data; the timing, progress and plans for our ongoing or future research, preclinical, and clinical development programs; changes to trial protocols for ongoing or new clinical trials; expectations and changes regarding the timing for regulatory filings; regulatory interactions; expectations and changes regarding the timing for enrollment and data; uncertainty and potential delays related to clinical drug development; the duration and impact of regulatory delays in our clinical programs; the timing of and our ability to obtain and maintain regulatory approvals for our therapeutic candidates, including as a result of disruptions at the FDA and other agencies caused by shutdowns, funding shortages, and policies pursued by the current U.S. administration; manufacturing risks; competition from other therapies or products; estimates of market size; other matters that could affect the sufficiency of existing cash, cash equivalents, and short-term investments to fund operations; our financial position; our future operating results and financial performance; Viridian’s intellectual property position; the timing of preclinical and clinical trial activities and reporting results from same; that our product candidates may not be commercially successful, if approved; and other risks described from time to time in the "Risk Factors" section of our filings with the Securities and Exchange Commission (SEC), including those described in our most recent Annual Report on Form 10-K or Quarterly Report on Form 10-Q, as applicable, and supplemented from time to time by our Current Reports on Form 8-K. Any forward-looking statement speaks only as of the date on which it was made. Neither the company, nor its affiliates, advisors, or representatives, undertake any obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise, except as required by law. These forward-looking statements should not be relied upon as representing the company’s views as of any date subsequent to the date hereof. View source version on businesswire.com: https://www.businesswire.com/news/home/20260505135001/en/ Contacts Investors Greg Rossino [email protected] Media Lisa Lopez [email protected]
Investor releaseQuarter not tagged2026-05-05PDUFA Decision Nears as Viridian Therapeutics (VRDN) Advances TED Pipeline and Reports Q1 Results
InvestorsHub
PDUFA Decision Nears as Viridian Therapeutics (VRDN) Advances TED Pipeline and Reports Q1 Results
Regulatory milestones and late-stage clinical progress position the company ahead of a key FDA decision in June. Viridian Therapeutics, Inc. (NASDAQ:VRDN) reported first-quarter 2026 results alongside updates on its pipeline, with a PDUFA decision for veligrotug in thyroid eye disease (TED) set for June 30, 2026. The upcoming regulatory milestone is central for investors, as it could determine near-term commercialization and revenue potential. Viridian (NASDAQ:VRDN) faces a PDUFA decision on June 30, 2026 for veligrotug, a key catalyst. The company is launch-ready, with commercial infrastructure and supply chain already in place. Positive Phase 3 data for elegrobart supports a future BLA submission in Q1 2027. Cash position of $762M provides funding for pipeline execution and launch activities. Rising SG&A and net losses reflect increased commercialization spending ahead of potential approval. Viridian reported progress across its thyroid eye disease (TED) portfolio, led by veligrotug, which is under FDA Priority Review with a PDUFA target action date of June 30, 2026. The company stated it has completed hiring of field teams and established supply chain infrastructure in preparation for launch. The company also submitted a Marketing Authorization Application (MAA) to the European Medicines Agency in January 2026, which was accepted for review in February. In addition, Viridian announced positive topline data from two Phase 3 trials—REVEAL-1 and REVEAL-2—for elegrobart (VRDN-003), covering both active and chronic TED. The company plans to submit a Biologics License Application (BLA) in the first quarter of 2027. Beyond TED, the company continues to advance earlier-stage programs, including its TSHR antibody program and FcRn inhibitor portfolio, with additional data and development plans expected later in 2026. Financially, Viridian reported: Cash, cash equivalents, and investments of $762.2 million as of March 31, 2026 R&D expenses of $77.6 million, up slightly year over year SG&A expenses of $38.7 million, rising significantly due to commercial preparation Net loss of $104.9 million for the quarter The upcoming PDUFA decision represents a critical inflection point. Approval of veligrotug could transition Viridian from a development-stage biotech to a commercial-stage company, which may significantly alter its revenue profile and valuation framework. The com…Read full documentShow less
Regulatory milestones and late-stage clinical progress position the company ahead of a key FDA decision in June. Viridian Therapeutics, Inc. (NASDAQ:VRDN) reported first-quarter 2026 results alongside updates on its pipeline, with a PDUFA decision for veligrotug in thyroid eye disease (TED) set for June 30, 2026. The upcoming regulatory milestone is central for investors, as it could determine near-term commercialization and revenue potential. Viridian (NASDAQ:VRDN) faces a PDUFA decision on June 30, 2026 for veligrotug, a key catalyst. The company is launch-ready, with commercial infrastructure and supply chain already in place. Positive Phase 3 data for elegrobart supports a future BLA submission in Q1 2027. Cash position of $762M provides funding for pipeline execution and launch activities. Rising SG&A and net losses reflect increased commercialization spending ahead of potential approval. Viridian reported progress across its thyroid eye disease (TED) portfolio, led by veligrotug, which is under FDA Priority Review with a PDUFA target action date of June 30, 2026. The company stated it has completed hiring of field teams and established supply chain infrastructure in preparation for launch. The company also submitted a Marketing Authorization Application (MAA) to the European Medicines Agency in January 2026, which was accepted for review in February. In addition, Viridian announced positive topline data from two Phase 3 trials—REVEAL-1 and REVEAL-2—for elegrobart (VRDN-003), covering both active and chronic TED. The company plans to submit a Biologics License Application (BLA) in the first quarter of 2027. Beyond TED, the company continues to advance earlier-stage programs, including its TSHR antibody program and FcRn inhibitor portfolio, with additional data and development plans expected later in 2026. Financially, Viridian reported: Cash, cash equivalents, and investments of $762.2 million as of March 31, 2026 R&D expenses of $77.6 million, up slightly year over year SG&A expenses of $38.7 million, rising significantly due to commercial preparation Net loss of $104.9 million for the quarter The upcoming PDUFA decision represents a critical inflection point. Approval of veligrotug could transition Viridian from a development-stage biotech to a commercial-stage company, which may significantly alter its revenue profile and valuation framework. The company’s readiness for launch suggests it is positioned to move quickly if approval is granted. At the same time, increased operating expenses indicate higher execution risk tied to commercialization. Positive Phase 3 data for elegrobart strengthens the broader TED pipeline, potentially expanding the company’s long-term opportunity in the indication. However, regulatory outcomes and future trial results remain key variables. FDA PDUFA decision on veligrotug (June 30, 2026) Updates from the EMA review process Timing and details of elegrobart BLA submission (Q1 2027) Additional data from FcRn and TSHR programs in 2026 Commercial launch execution if approval is granted Viridian Therapeutics is approaching a pivotal regulatory event with veligrotug, while continuing to build out a broader TED-focused pipeline. The outcome of the upcoming FDA decision, along with execution on commercialization plans, will likely shape near-term investor sentiment and the company’s strategic trajectory. Viridian Therapeutics stock price
Investor releaseQuarter not tagged2026-05-05Viridian Therapeutics Announces Positive Topline Results from Elegrobart Phase 3 REVEAL‑2 Clinical Trial in Chronic Thyroid Eye Disease
Business Wire
Viridian Therapeutics Announces Positive Topline Results from Elegrobart Phase 3 REVEAL‑2 Clinical Trial in Chronic Thyroid Eye Disease
- REVEAL-2 met its primary endpoint with a highly statistically significant treatment effect - - Elegrobart Q4W and Q8W achieved 50% and 54% proptosis responder rates (PRR) at week 24, respectively, versus 15% placebo, both highly statistically significant results (p < 0.0001) - - Elegrobart Q4W achieved a statistically significant 61% diplopia responder rate at week 24, versus 38% placebo (p = 0.0118) - - Elegrobart was generally well tolerated in both dose groups, with a safety profile consistent with REVEAL‑1 and low rates of hearing impairment - - Elegrobart is the only subcutaneous program to demonstrate positive phase 3 data in both active and chronic TED pivotal clinical trials and has the potential to be the first autoinjector treatment for TED; BLA submission on track for Q1 2027 - - Conference call and webcast to be held today, May 5th at 8:00 a.m. ET - WALTHAM, Mass., May 05, 2026--(BUSINESS WIRE)--Viridian Therapeutics, Inc. (Nasdaq: VRDN), a biotechnology company focused on discovering, developing, and commercializing potentially best-in-class medicines for autoimmune and rare diseases, today announced positive topline data from the REVEAL‑2 phase 3 clinical trial of elegrobart in patients with chronic thyroid eye disease (TED). Elegrobart is a subcutaneously delivered, half‑life‑extended monoclonal antibody targeting the insulin‑like growth factor‑1 receptor (IGF‑1R). REVEAL‑2 evaluated two dosing regimens, every four weeks (Q4W) and every eight weeks (Q8W), compared with placebo. "We are excited by today’s positive REVEAL 2 results and view these data as a major step forward for the chronic TED patient population. Given the IV-like proptosis response and our plans to launch with an at-home autoinjector, we believe elegrobart can meaningfully attract chronic patients to seek treatment. Elegrobart’s unmatched simplicity and convenience could uniquely drive expansion of the large and underserved chronic TED market," said Steve Mahoney, President and Chief Executive Officer of Viridian Therapeutics. "With our anticipated launch of veligrotug, which is a short IV infusion course, and two positive phase 3 REVEAL pivotal clinical trials supporting both Q4 weekly and Q8 weekly subcutaneous dosing for elegrobart, our portfolio has the potential to offer anti-IGF-1R efficacy and safety in convenient treatment regimens for TED patients with active or chr…Read full documentShow less
- REVEAL-2 met its primary endpoint with a highly statistically significant treatment effect - - Elegrobart Q4W and Q8W achieved 50% and 54% proptosis responder rates (PRR) at week 24, respectively, versus 15% placebo, both highly statistically significant results (p < 0.0001) - - Elegrobart Q4W achieved a statistically significant 61% diplopia responder rate at week 24, versus 38% placebo (p = 0.0118) - - Elegrobart was generally well tolerated in both dose groups, with a safety profile consistent with REVEAL‑1 and low rates of hearing impairment - - Elegrobart is the only subcutaneous program to demonstrate positive phase 3 data in both active and chronic TED pivotal clinical trials and has the potential to be the first autoinjector treatment for TED; BLA submission on track for Q1 2027 - - Conference call and webcast to be held today, May 5th at 8:00 a.m. ET - WALTHAM, Mass., May 05, 2026--(BUSINESS WIRE)--Viridian Therapeutics, Inc. (Nasdaq: VRDN), a biotechnology company focused on discovering, developing, and commercializing potentially best-in-class medicines for autoimmune and rare diseases, today announced positive topline data from the REVEAL‑2 phase 3 clinical trial of elegrobart in patients with chronic thyroid eye disease (TED). Elegrobart is a subcutaneously delivered, half‑life‑extended monoclonal antibody targeting the insulin‑like growth factor‑1 receptor (IGF‑1R). REVEAL‑2 evaluated two dosing regimens, every four weeks (Q4W) and every eight weeks (Q8W), compared with placebo. "We are excited by today’s positive REVEAL 2 results and view these data as a major step forward for the chronic TED patient population. Given the IV-like proptosis response and our plans to launch with an at-home autoinjector, we believe elegrobart can meaningfully attract chronic patients to seek treatment. Elegrobart’s unmatched simplicity and convenience could uniquely drive expansion of the large and underserved chronic TED market," said Steve Mahoney, President and Chief Executive Officer of Viridian Therapeutics. "With our anticipated launch of veligrotug, which is a short IV infusion course, and two positive phase 3 REVEAL pivotal clinical trials supporting both Q4 weekly and Q8 weekly subcutaneous dosing for elegrobart, our portfolio has the potential to offer anti-IGF-1R efficacy and safety in convenient treatment regimens for TED patients with active or chronic disease." "Chronic TED remains a challenging condition. Many patients have been living with this disease for years or decades and would benefit from an effective and convenient treatment option," said John Mandeville, MD, PhD, an oculoplastic surgeon at Ophthalmic Consultants of Boston and who is also a clinical associate at the Massachusetts General Hospital. "These REVEAL 2 results demonstrate the potential for elegrobart to provide meaningful improvement in the signs and symptoms of TED in as few as three doses. What’s more, a simple autoinjector that patients can use at home could be an attractive option for many patients living with chronic disease." Elegrobart REVEAL‑2 Phase 3 Topline Results REVEAL‑2 assessed the efficacy and safety of subcutaneous Q4W or Q8W elegrobart versus placebo in patients with chronic TED. The clinical trial enrolled 204 patients, randomized 1:1:1 to elegrobart Q4W (n = 70), elegrobart Q8W (n = 68), and placebo (n = 66). REVEAL‑2 Efficacy REVEAL-2 met its primary endpoint for both the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) with high statistical significance (p < 0.0001). In addition, REVEAL-2 met all its proptosis key secondary endpoints in the Q4W and Q8W treatment arms with high statistical significance, and the Q4W treatment arm showed a statistically significant diplopia responder rate at week 24. Efficacy was generally consistent regardless of baseline Clinical Activity Score (CAS). Results from primary and all key secondary endpoints at week 24 are presented below: Results with p < 0.025 are statistically significant. 1Participants with both proptosis and CAS response; CAS response defined as no worsening in CAS from baseline in study eye, without deterioration in fellow eye (≥2-point increase) REVEAL-2 Safety Elegrobart was generally well tolerated in REVEAL‑2 with a safety profile consisting of adverse events generally expected from the anti-IGF-1R class, the vast majority of which were mild. Rates of hearing impairment were low in both the Q4W and Q8W treatment arms (4.1% and 8.8% placebo-adjusted rates, respectively). 91% of elegrobart-treated patients completed the full course of treatment, and there were no treatment-related serious adverse events (SAEs). Elegrobart BLA Submission Expected in Q1 2027 REVEAL‑2 is the second successful pivotal phase 3 clinical trial for elegrobart, following positive results from REVEAL‑1 in active TED. Viridian remains on track to submit a Biologics License Application (BLA) to the U.S. FDA for elegrobart in Q1 2027. If approved, elegrobart has the potential to offer a convenient, at‑home treatment in as few as three doses for both active and chronic patients. Veligrotug on Track with a PDUFA Target Action Date of June 30, 2026 Viridian is prepared for the planned U.S. commercial launch for veligrotug, its lead program for TED. Viridian anticipates the veligrotug commercial and medical affairs infrastructure will support a potential elegrobart launch, if approved, with limited incremental investment. Veligrotug was granted Breakthrough Therapy Designation from the FDA, and its BLA is under Priority Review at the FDA with a Prescription Drug User Fee Act (PDUFA) target action date of June 30, 2026. Conference call and webcast information Viridian will host a conference call today at 8:00 a.m. ET to discuss the REVEAL‑2 topline data. Dial‑in (U.S.): (800) 715-9871 Dial‑in (International): +1 (646) 307-1963 Conference ID: 7373356 A live webcast of the conference call can be accessed through the "Events" section in the Investors page of the Viridian Therapeutics website. Following the live webcast, an archived version of the call will also be available on the website. About Viridian Therapeutics Viridian is a biotechnology company focused on discovering, developing, and commercializing potential best-in-class medicines for patients with autoimmune and rare diseases. Viridian’s expertise in antibody discovery and protein engineering enables the development of differentiated therapeutic candidates for validated drug targets and disease-driving mechanisms in autoimmune and rare diseases. Viridian is advancing multiple late-stage, anti-insulin-like growth factor-1 receptor (IGF-1R) candidates in the clinic for the treatment of patients with thyroid eye disease (TED). The company conducted a pivotal program for veligrotug, including two global phase 3 clinical trials, THRIVE and THRIVE-2, to evaluate its efficacy and safety in patients with active and chronic TED. THRIVE and THRIVE-2 reported positive topline data, meeting their primary endpoints and all secondary endpoints. Viridian is also advancing elegrobart as the potential first subcutaneous autoinjector for the treatment of TED. Viridian is conducting an ongoing pivotal program for elegrobart, including two global phase 3 pivotal clinical trials, REVEAL-1 and REVEAL-2, to evaluate the efficacy and safety of elegrobart in patients with active and chronic TED. REVEAL-1 and REVEAL-2 reported positive topline data, meeting their primary endpoints and multiple secondary endpoints. In addition to its IGF‑1R inhibitor portfolio, Viridian is developing an anti–thyroid‑stimulating hormone receptor (TSHR) program designed as a potential therapy for TED and Graves’ disease. Viridian is also advancing a novel portfolio of neonatal Fc receptor (FcRn) inhibitors, including VRDN-006 and VRDN-008, which have the potential to be developed in multiple autoimmune diseases. Viridian is based in Waltham, Massachusetts. For more information, please visit www.viridiantherapeutics.com. Follow Viridian on LinkedIn and X. Forward Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of words such as, but not limited to, "anticipate," "believe," "become," "continue," "could," "design," "estimate," "expect," "intend," "may," "might," "on track," "plan," "potential," "predict," "project," "should," "target," "will," or "would" or other similar terms or expressions that concern our expectations, plans and intentions. Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based on our current beliefs, expectations, and assumptions. Forward-looking statements include, without limitation, statements regarding: preclinical development, clinical development, and anticipated commercialization of Viridian’s product candidates; Viridian’s expectations regarding the anticipated timing or likelihood of regulatory submissions and approvals, including the anticipated approval of the BLA for veligrotug and the anticipated submission of a BLA for elegrobart in Q1 2027; elegrobart’s potential to be the potential first subcutaneous therapy for the treatment of TED and its potential to launch commercially with an at-home autoinjector; the potential benefits of elegrobart for patients, including its viability as a compelling solution for patients living with both active and chronic disease and provide meaningful improvement in the signs and symptoms of TED in as few as three doses; Viridian’s expectations with the market size and position; that the veligrotug commercial infrastructure will support a potential elegrobart launch, if approved, with limited incremental investment; elegrobart’s potential to expand the market for products in TED, if approved; and Viridian’s product candidates potentially being best-in-class. New risks and uncertainties may emerge from time to time, and it is not possible to predict all risks and uncertainties. No representations or warranties (expressed or implied) are made about the accuracy of any such forward-looking statements. Such forward-looking statements are subject to a number of material risks and uncertainties including but not limited to: potential utility, efficacy, potency, safety, clinical benefits, clinical response, and convenience of Viridian’s product candidates; that results or data from completed or ongoing clinical trials may not be representative of the results of ongoing or future clinical trials; that the results of ongoing or future clinical trials may not support submission for regulatory approvals; the timing, progress and plans for our ongoing or future research, preclinical, and clinical development programs; changes to trial protocols for ongoing or new clinical trials; expectations and changes regarding the timing for regulatory filings; expectations and changes regarding the timing for enrollment and data; uncertainty and potential delays related to clinical drug development; the duration and impact of regulatory delays in our clinical programs; the timing of and our ability to obtain and maintain regulatory approvals for our therapeutic candidates; manufacturing risks; competition from other therapies or products; estimates of market size; other matters that could affect the sufficiency of existing cash, cash equivalents, and short-term investments to fund operations; our financial position; our future operating results and financial performance; Viridian’s intellectual property position; that our product candidates may not be commercially successful, if approved; and other risks described from time to time in the "Risk Factors" section of our filings with the Securities and Exchange Commission (SEC), including those described in our most recent Annual Report on Form 10-K or Quarterly Report on Form 10-Q, as applicable, and supplemented from time to time by our Current Reports on Form 8-K. Any forward-looking statement speaks only as of the date on which it was made. Neither the company, nor its affiliates, advisors, or representatives, undertake any obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise, except as required by law. These forward-looking statements should not be relied upon as representing the company’s views as of any date subsequent to the date hereof. View source version on businesswire.com: https://www.businesswire.com/news/home/20260505926208/en/ Contacts Investors Greg Rossino [email protected] Media Lisa Lopez [email protected]
Investor releaseQuarter not tagged2026-04-17Evercore ISI Adjusts Viridian Therapeutics, Inc. (VRDN) Outlook in Pre-Earnings Preview
Insider Monkey
Evercore ISI Adjusts Viridian Therapeutics, Inc. (VRDN) Outlook in Pre-Earnings Preview
We recently compiled a list of the 10 Best Beaten Down Stocks to Invest in According to Analysts. Viridian Therapeutics, Inc. is among the best 52-week low stocks on our list. TheFly reported on April 13 that Evercore ISI reduced its price target on VRDN to $24 from $32 while maintaining an Outperform rating ahead of the company’s first-quarter earnings update. The adjustment reflects a revised outlook incorporated into the firm’s preview of upcoming results. In other news, it was reported earlier on April 6 that Shares of Viridian Therapeutics, Inc. (NASDAQ:VRDN) declined sharply after Amgen reported positive Phase 3 results for Tepezza delivered via subcutaneous injection using an on-body device in patients with moderate to severe active thyroid eye disease. The results included achievement of both primary and secondary endpoints, increasing competitive pressure in the same treatment area where Viridian is also developing a therapy for thyroid eye disease. Following the announcement, VRDN’s stock dropped approximately 19%, or $3.61, trading around $15.23 in morning activity. The move reflected investor concern that the new clinical data from a competing program could impact Viridian’s future commercial positioning and market expectations within the TED treatment landscape, particularly as both companies target overlapping patient populations and indications. Viridian Therapeutics, Inc. (NASDAQ:VRDN) is a clinical-stage biopharmaceutical company focused on developing antibody-based therapies for serious rare diseases. It is primarily targeting thyroid eye disease with innovative biologic treatments designed to improve patient outcomes and reduce disease burden. While we acknowledge the potential of VRDN as an investment, we believe certain AI stocks offer greater upside potential and carry less downside risk. If you're looking for an extremely undervalued AI stock that also stands to benefit significantly from Trump-era tariffs and the onshoring trend, see our free report on the best short-term AI stock. READ NEXT: 10 Best Healthcare Stocks to Buy and Hold for 3 Years and 10 Best Beaten Down Stocks to Invest in According to Analysts. Disclosure: None. Follow Insider Monkey on Google News.
Investor releaseQuarter not tagged2026-04-02Are Viridian Therapeutics' (VRDN) REVEAL-1 Results Enough To Redefine Its TED Competitive Position?
Simply Wall St.
Are Viridian Therapeutics' (VRDN) REVEAL-1 Results Enough To Redefine Its TED Competitive Position?
Viridian Therapeutics recently reported positive topline Phase 3 REVEAL-1 results for elegrobart in active thyroid eye disease, with both four-week and eight-week subcutaneous dosing regimens achieving statistically significant improvements in eye bulging and double vision versus placebo and showing a generally manageable safety profile. An important nuance for investors is that, despite these clinically meaningful outcomes and convenient subcutaneous dosing, questions have emerged about how elegrobart’s efficacy and overall profile compare with existing therapies, creating debate about its eventual role in the thyroid eye disease treatment landscape. We’ll now examine how these REVEAL-1 data, particularly the balance between efficacy and subcutaneous convenience, influence Viridian’s broader investment narrative. AI is about to change healthcare. These 33 stocks are working on everything from early diagnostics to drug discovery. The best part - they are all under $10b in market cap - there's still time to get in early. To own Viridian today, you have to believe that thyroid eye disease can support more than one meaningful product and that Viridian’s dual approach, with veligrotug and elegrobart, can carve out a durable position. The REVEAL-1 readout reinforces that elegrobart is an active drug with the kind of subcutaneous convenience many physicians and patients say they want, but the sharp share price drop shows how much the market is questioning its competitiveness versus existing options. In the near term, the key swing factors now look clearer: the FDA decision on veligrotug in mid‑2026 and the REVEAL-2 data in chronic TED, which together may redefine how investors think about Viridian’s overall TED franchise. At the same time, the company is still loss‑making, has diluted shareholders, and trades on rich sales multiples, so any further hint that its TED portfolio could struggle commercially is likely to matter more after REVEAL‑1 than it did before. However, there is a financing and dilution risk here that investors should not ignore. Despite retreating, Viridian Therapeutics' shares might still be trading above their fair value and there could be some more downside. Discover how much. Three Simply Wall St Community fair values for Viridian span from US$0.18 to about US$160.98, underlining how far apart individual views can be. Set that against the re…Read full documentShow less
Viridian Therapeutics recently reported positive topline Phase 3 REVEAL-1 results for elegrobart in active thyroid eye disease, with both four-week and eight-week subcutaneous dosing regimens achieving statistically significant improvements in eye bulging and double vision versus placebo and showing a generally manageable safety profile. An important nuance for investors is that, despite these clinically meaningful outcomes and convenient subcutaneous dosing, questions have emerged about how elegrobart’s efficacy and overall profile compare with existing therapies, creating debate about its eventual role in the thyroid eye disease treatment landscape. We’ll now examine how these REVEAL-1 data, particularly the balance between efficacy and subcutaneous convenience, influence Viridian’s broader investment narrative. AI is about to change healthcare. These 33 stocks are working on everything from early diagnostics to drug discovery. The best part - they are all under $10b in market cap - there's still time to get in early. To own Viridian today, you have to believe that thyroid eye disease can support more than one meaningful product and that Viridian’s dual approach, with veligrotug and elegrobart, can carve out a durable position. The REVEAL-1 readout reinforces that elegrobart is an active drug with the kind of subcutaneous convenience many physicians and patients say they want, but the sharp share price drop shows how much the market is questioning its competitiveness versus existing options. In the near term, the key swing factors now look clearer: the FDA decision on veligrotug in mid‑2026 and the REVEAL-2 data in chronic TED, which together may redefine how investors think about Viridian’s overall TED franchise. At the same time, the company is still loss‑making, has diluted shareholders, and trades on rich sales multiples, so any further hint that its TED portfolio could struggle commercially is likely to matter more after REVEAL‑1 than it did before. However, there is a financing and dilution risk here that investors should not ignore. Despite retreating, Viridian Therapeutics' shares might still be trading above their fair value and there could be some more downside. Discover how much. Three Simply Wall St Community fair values for Viridian span from US$0.18 to about US$160.98, underlining how far apart individual views can be. Set that against the recent post‑REVEAL‑1 share price fall and you get a sense of how differently people are weighing Viridian’s TED pipeline risk and its potential impact on future performance. Explore 3 other fair value estimates on Viridian Therapeutics - why the stock might be worth over 8x more than the current price! Disagree with this assessment? Extraordinary investment returns rarely come from following the herd, so go with your instincts. A great starting point for your Viridian Therapeutics research is our analysis highlighting 2 key rewards and 1 important warning sign that could impact your investment decision. Our free Viridian Therapeutics research report provides a comprehensive fundamental analysis summarized in a single visual - the Snowflake - making it easy to evaluate Viridian Therapeutics' overall financial health at a glance. Opportunities like this don't last. These are today's most promising picks. Check them out now: Find 63 companies with promising cash flow potential yet trading below their fair value. We've uncovered the 12 dividend fortresses yielding 5%+ that don't just survive market storms, but thrive in them. This technology could replace computers: discover 25 stocks that are working to make quantum computing a reality. 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 VRDN. Have feedback on this article? Concerned about the content? Get in touch with us directly. Alternatively, email [email protected]
Investor releaseQuarter not tagged2026-03-31Viridian Therapeutics Crashes On 'Positive, But Lackluster' Thyroid Eye Disease Results
Investor's Business Daily
Viridian Therapeutics Crashes On 'Positive, But Lackluster' Thyroid Eye Disease Results
Viridian Therapeutics stock crashed Monday on "positive, but lackluster" final-phase results for its thyroid eye disease treatment.
Investor releaseQuarter not tagged2026-02-26MiMedx (MDXG) Q4 Earnings and Revenues Beat Estimates
Zacks
MiMedx (MDXG) Q4 Earnings and Revenues Beat Estimates
MiMedx (MDXG) came out with quarterly earnings of $0.14 per share, beating the Zacks Consensus Estimate of $0.09 per share. This compares to earnings of $0.07 per share a year ago. These figures are adjusted for non-recurring items. This quarterly report represents an earnings surprise of +55.56%. A quarter ago, it was expected that this developer of biomaterials made from sterilized human amniotic membrane would post earnings of $0.07 per share when it actually produced earnings of $0.15, delivering a surprise of +114.29%. Over the last four quarters, the company has surpassed consensus EPS estimates three times. MiMedx, which belongs to the Zacks Medical - Biomedical and Genetics industry, posted revenues of $118.1 million for the quarter ended December 2025, surpassing the Zacks Consensus Estimate by 14.93%. This compares to year-ago revenues of $92.91 million. The company has topped consensus revenue estimates four times over the last four quarters. The sustainability of the stock's immediate price movement based on the recently-released numbers and future earnings expectations will mostly depend on management's commentary on the earnings call. MiMedx shares have lost about 21% since the beginning of the year versus the S&P 500's gain of 0.7%. While MiMedx has underperformed the market so far this year, the question that comes to investors' minds is: what's next for the stock? There are no easy answers to this key question, but one reliable measure that can help investors address this is the company's earnings outlook. Not only does this include current consensus earnings expectations for the coming quarter(s), but also how these expectations have changed lately. Empirical research shows a strong correlation between near-term stock movements and trends in earnings estimate revisions. Investors can track such revisions by themselves or rely on a tried-and-tested rating tool like the Zacks Rank, which has an impressive track record of harnessing the power of earnings estimate revisions. Ahead of this earnings release, the estimate revisions trend for MiMedx was unfavorable. While the magnitude and direction of estimate revisions could change following the company's just-released earnings report, the current status translates into a Zacks Rank #4 (Sell) for the stock. So, the shares are expected to underperform the market in the near future. You can see the…Read full documentShow less
MiMedx (MDXG) came out with quarterly earnings of $0.14 per share, beating the Zacks Consensus Estimate of $0.09 per share. This compares to earnings of $0.07 per share a year ago. These figures are adjusted for non-recurring items. This quarterly report represents an earnings surprise of +55.56%. A quarter ago, it was expected that this developer of biomaterials made from sterilized human amniotic membrane would post earnings of $0.07 per share when it actually produced earnings of $0.15, delivering a surprise of +114.29%. Over the last four quarters, the company has surpassed consensus EPS estimates three times. MiMedx, which belongs to the Zacks Medical - Biomedical and Genetics industry, posted revenues of $118.1 million for the quarter ended December 2025, surpassing the Zacks Consensus Estimate by 14.93%. This compares to year-ago revenues of $92.91 million. The company has topped consensus revenue estimates four times over the last four quarters. The sustainability of the stock's immediate price movement based on the recently-released numbers and future earnings expectations will mostly depend on management's commentary on the earnings call. MiMedx shares have lost about 21% since the beginning of the year versus the S&P 500's gain of 0.7%. While MiMedx has underperformed the market so far this year, the question that comes to investors' minds is: what's next for the stock? There are no easy answers to this key question, but one reliable measure that can help investors address this is the company's earnings outlook. Not only does this include current consensus earnings expectations for the coming quarter(s), but also how these expectations have changed lately. Empirical research shows a strong correlation between near-term stock movements and trends in earnings estimate revisions. Investors can track such revisions by themselves or rely on a tried-and-tested rating tool like the Zacks Rank, which has an impressive track record of harnessing the power of earnings estimate revisions. Ahead of this earnings release, the estimate revisions trend for MiMedx was unfavorable. While the magnitude and direction of estimate revisions could change following the company's just-released earnings report, the current status translates into a Zacks Rank #4 (Sell) for the stock. So, the shares are expected to underperform the market in the near future. You can see the complete list of today's Zacks #1 Rank (Strong Buy) stocks here. It will be interesting to see how estimates for the coming quarters and the current fiscal year change in the days ahead. The current consensus EPS estimate is breakeven on $77.5 million in revenues for the coming quarter and $0.13 on $362.5 million in revenues for the current fiscal year. Investors should be mindful of the fact that the outlook for the industry can have a material impact on the performance of the stock as well. In terms of the Zacks Industry Rank, Medical - Biomedical and Genetics is currently in the top 37% of the 250 plus Zacks industries. Our research shows that the top 50% of the Zacks-ranked industries outperform the bottom 50% by a factor of more than 2 to 1. Another stock from the same industry, Viridian Therapeutics, Inc. (VRDN), has yet to report results for the quarter ended December 2025. This company is expected to post quarterly loss of $0.90 per share in its upcoming report, which represents a year-over-year change of -11.1%. The consensus EPS estimate for the quarter has remained unchanged over the last 30 days. Viridian Therapeutics, Inc.'s revenues are expected to be $18.47 million, up 26280% from the year-ago quarter. Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report MiMedx Group, Inc (MDXG) : Free Stock Analysis Report Viridian Therapeutics, Inc. (VRDN) : Free Stock Analysis Report This article originally published on Zacks Investment Research (zacks.com). Zacks Investment Research
Investor releaseQuarter not tagged2026-02-26Viridian Therapeutics Highlights Recent Progress and Reports Fourth Quarter and Full Year 2025 Financial Results
Business Wire
Viridian Therapeutics Highlights Recent Progress and Reports Fourth Quarter and Full Year 2025 Financial Results
- PDUFA target action date of June 30, 2026 for veligrotug for thyroid eye disease (TED); U.S. commercial preparations on track to support anticipated launch - - Marketing Authorization Application (MAA) for veligrotug for TED submitted to the European Medicines Agency (EMA) in January 2026 - - Phase 3 topline data readout for subcutaneous elegrobart (VRDN‑003) REVEAL‑1 and REVEAL‑2 studies on track for Q1 and Q2 2026 in active and chronic TED, respectively - - Advanced VRDN-008 into phase 1 clinical trial in healthy volunteers; data on track for 2H 2026 - - Strong balance sheet with cash, cash equivalents, and short-term investments of $875 million as of December 31, 2025 - - Based on existing cash, potential near-term milestones from 2025 royalty agreement, and anticipated commercial revenues, if both veligrotug and elegrobart are approved, the company expects current business plans to be funded through profitability - WALTHAM, Mass., February 26, 2026--(BUSINESS WIRE)--Viridian Therapeutics, Inc. (Nasdaq: VRDN), a biotechnology company focused on discovering, developing, and commercializing potentially best-in-class medicines for serious and rare diseases, today reported recent business highlights and financial results for the fourth quarter and full year ended December 31, 2025. "We enter 2026 with the momentum of our continued execution," said Steve Mahoney, President and Chief Executive Officer of Viridian. "With the veligrotug BLA filing under Priority Review and a PDUFA target date of June 30, 2026, we are well-prepared for our potential first commercial launch, a significant milestone for the company and for patients with TED. The submission of our MAA to the EMA supports the long-term, global opportunity for veligrotug. We are advancing toward reporting pivotal REVEAL-1 topline data for elegrobart next month, which we believe has the potential to be a best-in-class subcutaneous therapy for TED patients. Our goal is to establish veligrotug and elegrobart as foundational therapies for TED, while driving our pipeline forward to address additional indications and unmet needs." Recent Business Highlights TED PORTFOLIO Veligrotug: U.S. Biologics License Application (BLA) Priority Review ongoing; Prescription Drug User Fee Act (PDUFA) target action date of June 30, 2026 U.S. Food and Drug Administration (FDA) Priority Review of veligrotug BLA for TED is o…Read full documentShow less
- PDUFA target action date of June 30, 2026 for veligrotug for thyroid eye disease (TED); U.S. commercial preparations on track to support anticipated launch - - Marketing Authorization Application (MAA) for veligrotug for TED submitted to the European Medicines Agency (EMA) in January 2026 - - Phase 3 topline data readout for subcutaneous elegrobart (VRDN‑003) REVEAL‑1 and REVEAL‑2 studies on track for Q1 and Q2 2026 in active and chronic TED, respectively - - Advanced VRDN-008 into phase 1 clinical trial in healthy volunteers; data on track for 2H 2026 - - Strong balance sheet with cash, cash equivalents, and short-term investments of $875 million as of December 31, 2025 - - Based on existing cash, potential near-term milestones from 2025 royalty agreement, and anticipated commercial revenues, if both veligrotug and elegrobart are approved, the company expects current business plans to be funded through profitability - WALTHAM, Mass., February 26, 2026--(BUSINESS WIRE)--Viridian Therapeutics, Inc. (Nasdaq: VRDN), a biotechnology company focused on discovering, developing, and commercializing potentially best-in-class medicines for serious and rare diseases, today reported recent business highlights and financial results for the fourth quarter and full year ended December 31, 2025. "We enter 2026 with the momentum of our continued execution," said Steve Mahoney, President and Chief Executive Officer of Viridian. "With the veligrotug BLA filing under Priority Review and a PDUFA target date of June 30, 2026, we are well-prepared for our potential first commercial launch, a significant milestone for the company and for patients with TED. The submission of our MAA to the EMA supports the long-term, global opportunity for veligrotug. We are advancing toward reporting pivotal REVEAL-1 topline data for elegrobart next month, which we believe has the potential to be a best-in-class subcutaneous therapy for TED patients. Our goal is to establish veligrotug and elegrobart as foundational therapies for TED, while driving our pipeline forward to address additional indications and unmet needs." Recent Business Highlights TED PORTFOLIO Veligrotug: U.S. Biologics License Application (BLA) Priority Review ongoing; Prescription Drug User Fee Act (PDUFA) target action date of June 30, 2026 U.S. Food and Drug Administration (FDA) Priority Review of veligrotug BLA for TED is ongoing with a PDUFA target action date of June 30, 2026. Veligrotug received Breakthrough Therapy designation from the FDA in 2025. Submitted an MAA to the EMA in January 2026, on schedule. Positive pivotal results from THRIVE and THRIVE‑2 underpin veligrotug’s clinical profile in active and chronic TED. Across active and chronic TED, following five infusions, veligrotug demonstrated rapid onset of treatment effect, clinically meaningful improvements in proptosis and diplopia, durable responses, and was generally well-tolerated. Commercial preparations continue and are on track to support a planned mid-2026 U.S. commercial launch, if approved, including the build-out of field leadership, sales, market access, and patient services. Medical affairs engagement continues to expand, educating key opinion leaders and healthcare professionals on veligrotug clinical data and profile. Elegrobart (VRDN-003): REVEAL topline data release on track REVEAL‑1 topline data in active TED on track for Q1 2026 and REVEAL‑2 topline data in chronic TED on track for Q2 2026. Elegrobart is designed to be an infrequent, low-volume, self‑administered at-home subcutaneous therapy using a commercially validated autoinjector with either every-4-week or every-8-week dosing. TSHR program: Investigational New Drug (IND) submission anticipated in Q4 2026 Developing a potential best-in-class, half-life extended, monoclonal anti-TSHR antibody, designed for subcutaneous delivery in an autoinjector with the potential to support extended dosing intervals. Viridian anticipates clinical potential for this program in TED and Graves’ disease and plans to submit an IND in Q4 2026. FCRN INHIBITOR PORTFOLIO VRDN‑006: Phase 1 proof‑of‑concept IgG reduction; 2026 development plan update In a phase 1 clinical trial in healthy volunteers, VRDN-006 showed IgG reductions consistent with the FcRn inhibitor class, spared albumin and LDL, and was generally well-tolerated. Viridian anticipates communicating development plans in 2026. VRDN‑008: IND cleared and phase 1 clinical trial initiated VRDN-008 IND cleared in January 2026. Phase 1 clinical trial in healthy volunteers is now enrolling participants; data expected in 2H 2026. Financial Results Cash Position: Cash, cash equivalents, and marketable securities were $874.7 million as of December 31, 2025, compared with $717.6 million as of December 31, 2024. Together with anticipated milestone payments from the DRI royalty agreement and anticipated future commercial revenues from veligrotug and elegrobart, if approved, the company expects to fund its current business plans through profitability. R&D Expenses: Research and development expenses for the year ended December 31, 2025 were $338.9 million, compared with $238.3 million for the year ended December 31, 2024. The increase in research and development expenses was driven by increased costs associated with ongoing clinical trials and manufacturing activities for our TED portfolio, additional investment in advancing our FcRn inhibitor portfolio and TSHR program, as well as increased personnel-related costs as a result of headcount increases. SG&A Expenses: Selling, general and administrative expenses for the year ended December 31, 2025 were $95.3 million, compared with $61.1 million for the year ended December 31, 2024. The increase in selling, general and administrative expenses was driven by preparatory commercial activities for veligrotug, including increased personnel-related costs as a result of headcount increases. Net Loss: Net loss for the year ended December 31, 2025 was $342.6 million, compared with $269.9 million for the same period in 2024. Shares Outstanding: As of December 31, 2025, Viridian had 116,126,148 shares of common stock outstanding on an as-converted basis, which included 101,826,500 shares of common stock and an aggregate 14,299,648 shares of common stock issuable upon the conversion of 134,864 and 79,620 shares of Series A and Series B preferred stock, respectively. Upcoming Investor Conferences Viridian will participate in the following upcoming investor conferences. Live webcasts of the presentation can be accessed under "Events and Presentations" on the Investors section of the Viridian website at viridiantherapeutics.com. Replays of the webcasts will be available following each event. TD Cowen 46th Annual Health Care Conference: Fireside chat on Wednesday, March 4, 2026, at 10:30 a.m. ET in Boston, MA Leerink Partners Global Healthcare Conference: Fireside chat on Monday, March 9, 2026, at 8:00 a.m. ET in Miami, FL About Viridian Therapeutics Viridian is a biopharmaceutical company focused on discovering, developing, and commercializing potential best-in-class medicines for patients with serious and rare diseases. Viridian’s expertise in antibody discovery and protein engineering enables the development of differentiated therapeutic candidates for validated drug targets and disease-driving mechanisms in autoimmune and rare diseases. Viridian is advancing multiple late-stage, anti-insulin-like growth factor-1 receptor (IGF-1R) candidates in the clinic for the treatment of patients with thyroid eye disease (TED). The company conducted a pivotal program for veligrotug, including two global phase 3 clinical trials (THRIVE and THRIVE-2), to evaluate its efficacy and safety in patients with active and chronic TED. Both THRIVE and THRIVE-2 reported positive topline data, meeting the primary and all secondary endpoints of each study. Viridian is also advancing elegrobart (VRDN-003) as a potential best-in-class subcutaneous therapy for the treatment of TED, including two ongoing global phase 3 pivotal clinical trials, REVEAL-1 and REVEAL-2, to evaluate the efficacy and safety of elegrobart in patients with active and chronic TED. In addition to its IGF‑1R inhibitor portfolio, Viridian is developing an anti–thyroid‑stimulating hormone receptor (TSHR) program designed as a potential therapy for TED and Graves’ disease. Viridian is also advancing a novel portfolio of neonatal Fc receptor (FcRn) inhibitors, including VRDN-006 and VRDN-008, which have the potential to be developed in multiple autoimmune diseases. Viridian is based in Waltham, Massachusetts. For more information, please visit www.viridiantherapeutics.com. Follow Viridian on LinkedIn and X. Forward Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of words such as, but not limited to, "anticipate," "believe," "become," "continue," "could," "design," "estimate," "expect," "intend," "may," "might," "on track," "plan," "potential," "predict," "project," "should," "target," "will," or "would" or other similar terms or expressions that concern our expectations, plans and intentions. Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based on our current beliefs, expectations, and assumptions. Forward-looking statements include, without limitation, statements regarding: preclinical development, clinical development, and anticipated commercialization of Viridian’s product candidates veligrotug, elegrobart, VRDN-006, and VRDN-008, including the VRDN-008 phase 1 clinical trial; anticipated data results and timing of their disclosure, including elegrobart topline data from the REVEAL-1 and REVEAL-2 trials; Viridian’s expectations regarding the anticipated timing or likelihood of regulatory submissions and approvals, including the anticipated approval of the BLA and MAA for veligrotug; the impact of Breakthrough Therapy Designation, and the impact of Priority Review, including the potential commercial launch of veligrotug in mid-2026, if approved; the potential utility, efficacy, potency, safety, clinical benefits, clinical response, convenience, and number of indications of veligrotug, elegrobart, VRDN-006, and VRDN-008; veligrotug’s potential to be the IV treatment-of-choice for active and chronic TED; elegrobart’s potential to be the best-in-class subcutaneous therapy for the treatment of TED; Viridian’s product candidates potentially being best-in-class; Viridian’s expectations regarding the potential commercialization, market size, and market opportunities of veligrotug and elegrobart, if approved; Viridian’s ability to receive milestone payments pursuant to its agreement with the DRI agreement; and that Viridian’s cash, potential near-term milestones from the DRI royalty agreement and anticipated commercial revenues, if veligrotug and elegrobart are approved, will be sufficient to fund its business plans through profitability. New risks and uncertainties may emerge from time to time, and it is not possible to predict all risks and uncertainties. No representations or warranties (expressed or implied) are made about the accuracy of any such forward-looking statements. Such forward-looking statements are subject to a number of material risks and uncertainties including but not limited to: potential utility, efficacy, potency, safety, clinical benefits, clinical response, and convenience of Viridian’s product candidates; that results or data from completed or ongoing clinical trials may not be representative of the results of ongoing or future clinical trials; that preliminary data may not be representative of final data; the timing, progress and plans for our ongoing or future research, preclinical, and clinical development programs; changes to trial protocols for ongoing or new clinical trials; expectations and changes regarding the timing for regulatory filings; regulatory interactions; expectations and changes regarding the timing for enrollment and data; uncertainty and potential delays related to clinical drug development; the duration and impact of regulatory delays in our clinical programs, including as a result of a prolonged government shutdown; the timing of and our ability to obtain and maintain regulatory approvals for our therapeutic candidates, including as a result of disruptions at the FDA and other agencies caused by shutdowns, funding shortages, and policies pursued by the current U.S. administration; manufacturing risks; competition from other therapies or products; estimates of market size; other matters that could affect the sufficiency of existing cash, cash equivalents, and short-term investments to fund operations; our financial position; our future operating results and financial performance; Viridian’s intellectual property position; the timing of preclinical and clinical trial activities and reporting results from same; that our product candidates may not be commercially successful, if approved; and other risks described from time to time in the "Risk Factors" section of our filings with the Securities and Exchange Commission (SEC), including those described in our most recent Annual Report on Form 10-K or Quarterly Report on Form 10-Q, as applicable, and supplemented from time to time by our Current Reports on Form 8-K. Any forward-looking statement speaks only as of the date on which it was made. Neither the company, nor its affiliates, advisors, or representatives, undertake any obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise, except as required by law. These forward-looking statements should not be relied upon as representing the company’s views as of any date subsequent to the date hereof. View source version on businesswire.com: https://www.businesswire.com/news/home/20260226760846/en/ Contacts Investors Greg Rossino [email protected] Media Lisa Lopez [email protected]
Investor releaseQuarter not tagged2025-11-17RBC Capital Remains Bullish on Viridian Therapeutics (VRDN) Following Q3 2025 Results
Insider Monkey
RBC Capital Remains Bullish on Viridian Therapeutics (VRDN) Following Q3 2025 Results
With significant upside potential, Viridian Therapeutics, Inc. (NASDAQ:VRDN) secures a spot on our list of the best small-cap biotech stocks to buy according to analysts. On November 6, 2025, RBC Capital raised its price target on Viridian Therapeutics, Inc. (NASDAQ:VRDN) from $41 to $45, while maintaining an “Outperform” rating. The investment firm’s bullish stance stemmed from clear visibility toward profitability, seen through its increased cash position of $888 million, thanks to financing deals, including $55 million from DRI royalty financing, a $70 million upfront Japan licensing agreement, a $289 million follow-on offering, and access to a $300 million credit facility. Furthermore, Viridian Therapeutics, Inc. (NASDAQ:VRDN) has completed key patient enrollments in its late-stage clinical studies. Readouts for active and chronic Thyroid Eye Disease (TED) are expected in Q1 and Q2 2026, respectively, driving the investment firm’s bullish stance. Meanwhile, Viridian Therapeutics, Inc. (NASDAQ:VRDN) reported Q3 2025 results on the previous day. The company closed the quarter with $490.9 million in cash on hand. The cash position further increased as a result of the financing deals. The quarter also marked a significant increase in R&D expenses, which grew from $69.2 million in the same quarter last year to $86.3 million. Viridian Therapeutics, Inc. (NASDAQ:VRDN) is focused on the development and commercialization of therapies for rare diseases. While we acknowledge the potential of VRDN as an investment, we believe certain AI stocks offer greater upside potential and carry less downside risk. If you're looking for an extremely undervalued AI stock that also stands to benefit significantly from Trump-era tariffs and the onshoring trend, see our free report on the best short-term AI stock. READ NEXT: 7 Best Oil and Gas Penny Stocks to Buy According to Analysts and Billionaire Jacob Rothschild’s RIT Capital Partners: 9 Stocks with Huge Upside Potential. Disclosure: None.
Investor releaseQuarter not tagged2025-11-05Viridian Therapeutics Reports Third Quarter 2025 Financial Results and Highlights Recent Progress
Business Wire
Viridian Therapeutics Reports Third Quarter 2025 Financial Results and Highlights Recent Progress
- Completed a comprehensive set of financing transactions in October 2025, securing access to up to $889 million of potential capital across equity, royalty, and credit - - Successful October submission of Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for veligrotug in thyroid eye disease (TED) and preparing for an anticipated U.S. commercial launch in mid-2026, if approved, under a Priority Review timeline - - Subcutaneous VRDN-003 topline data readout accelerated to Q1 2026 for REVEAL-1 and narrowed to Q2 2026 for REVEAL-2 for active and chronic TED, respectively; each study exceeded its enrollment target due to strong patient demand - - Neonatal Fc receptor (FcRn) inhibitor, VRDN-006, showed proof-of-concept IgG reduction and was sparing of albumin and LDL in a phase 1 healthy volunteer clinical trial; half-life extended FcRn inhibitor, VRDN-008, on track for 2025 Investigational New Drug (IND) filing with healthy volunteer data anticipated in 2H 2026 - - Cash position of approximately $887.9 million as of October 31, 2025, inclusive of upfront payments received in October from license, royalty, and debt agreements, as well as proceeds from the equity offering - - The company believes its existing cash, potential near-term milestones from the royalty agreement, and anticipated commercial revenues, if both veligrotug and VRDN-003 are approved, are expected to fund its current business plans through profitability - WALTHAM, Mass., November 05, 2025--(BUSINESS WIRE)--Viridian Therapeutics, Inc. (Nasdaq: VRDN), a biotechnology company focused on discovering, developing, and commercializing potentially best-in-class medicines for serious and rare diseases, today reported recent business highlights and financial results for the third quarter ended September 30, 2025. "The Viridian team continues to deliver strong results, highlighted by the successful submission of our BLA for veligrotug, completing enrollment in both pivotal clinical trials for VRDN-003, advancing our FcRn programs, and the completion of royalty financing, equity, and credit transactions resulting in a comprehensive financing package that we believe allows us to reach profitability," said Steve Mahoney, Viridian’s President and CEO. "We are laser-focused on commercial readiness to launch veligrotug by mid-2026, if we receive approval under Priority Review.…Read full documentShow less
- Completed a comprehensive set of financing transactions in October 2025, securing access to up to $889 million of potential capital across equity, royalty, and credit - - Successful October submission of Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for veligrotug in thyroid eye disease (TED) and preparing for an anticipated U.S. commercial launch in mid-2026, if approved, under a Priority Review timeline - - Subcutaneous VRDN-003 topline data readout accelerated to Q1 2026 for REVEAL-1 and narrowed to Q2 2026 for REVEAL-2 for active and chronic TED, respectively; each study exceeded its enrollment target due to strong patient demand - - Neonatal Fc receptor (FcRn) inhibitor, VRDN-006, showed proof-of-concept IgG reduction and was sparing of albumin and LDL in a phase 1 healthy volunteer clinical trial; half-life extended FcRn inhibitor, VRDN-008, on track for 2025 Investigational New Drug (IND) filing with healthy volunteer data anticipated in 2H 2026 - - Cash position of approximately $887.9 million as of October 31, 2025, inclusive of upfront payments received in October from license, royalty, and debt agreements, as well as proceeds from the equity offering - - The company believes its existing cash, potential near-term milestones from the royalty agreement, and anticipated commercial revenues, if both veligrotug and VRDN-003 are approved, are expected to fund its current business plans through profitability - WALTHAM, Mass., November 05, 2025--(BUSINESS WIRE)--Viridian Therapeutics, Inc. (Nasdaq: VRDN), a biotechnology company focused on discovering, developing, and commercializing potentially best-in-class medicines for serious and rare diseases, today reported recent business highlights and financial results for the third quarter ended September 30, 2025. "The Viridian team continues to deliver strong results, highlighted by the successful submission of our BLA for veligrotug, completing enrollment in both pivotal clinical trials for VRDN-003, advancing our FcRn programs, and the completion of royalty financing, equity, and credit transactions resulting in a comprehensive financing package that we believe allows us to reach profitability," said Steve Mahoney, Viridian’s President and CEO. "We are laser-focused on commercial readiness to launch veligrotug by mid-2026, if we receive approval under Priority Review. The recent financings, in particular our equity raise and royalty financing, significantly strengthen our balance sheet, putting us in an even stronger financial position to execute on our vision of building a leading commercial company starting with treatments for TED." Recent Business Highlights Company Financed to Anticipated Profitability $289 Million Public Equity Offering in October 2025. On October 21, 2025, the company announced a public offering of common stock with gross proceeds of approximately $251.4 million, consisting of 11,425,000 shares sold at a public offering price of $22.00 per share. Following the announcement, the underwriters exercised their over-allotment option to purchase an additional 1,713,750 shares of common stock at a public offering price of $22.00 per share for an additional $37.7 million of gross proceeds. Total gross proceeds from the equity offering consisting of 13,138,750 shares sold were $289.1 million. $170 Million in Upfront and Potential Near-Term Milestones from DRI Royalty Financing. Viridian closed a royalty financing with DRI Healthcare Acquisitions LP (DRI) in October 2025 for up to $300 million total capital, including $55 million upfront and $115 million in near-term milestones tied to positive VRDN-003 topline data and U.S. veligrotug marketing approval. Viridian will pay DRI tiered royalties on annual U.S. net sales of veligrotug and VRDN-003. Amended Hercules Capital Credit Facility. The company signed an amended agreement with Hercules Capital, Inc. (Hercules) in October 2025, which provides for up to $300 million in available capital and extends Viridian’s interest-only payment period. The agreement required a $50 million draw at closing, resulting in $30 million of immediate proceeds after repayment of the company’s prior Hercules facility. The new facility provides additional non-dilutive capital at the company’s discretion upon achievement of specified milestones. The company believes that its current cash, potential near-term milestones from the royalty agreement, and anticipated revenues, if both veligrotug and VRDN-003 are approved, will fund Viridian’s current business plans through profitability. Preparing for Veligrotug Commercial Launch Biologics License Application Submitted. In October, Viridian successfully submitted the veligrotug BLA to the U.S. FDA, including a request for Priority Review. Veligrotug was granted Breakthrough Therapy Designation in May 2025, which supports eligibility for Priority Review. If approved and Priority Review is granted, Viridian expects a U.S. commercial launch in mid-2026. Marketing Authorization Application (MAA). Viridian is on track to submit a Marketing Authorization Application to the European Medicines Agency in Q1 2026. Strong Commercial and Medical Preparation for Launch: Experienced field leadership teams in place, including sales, market access, patient services and medical affairs with full commercial build out on track for a potential mid-2026 launch; Focused effort on the ~2,000 core prescribers driving patient prescriptions in the currently annualizing $2 billion new-start TED market; Comprehensive market research confirms strong enthusiasm for the veligrotug investigational product profile among high-prescribing key opinion leaders (KOLs) and healthcare professionals (HCPs); payer and infusion center research indicates high receptivity to the veligrotug value proposition; and Medical Affairs continues extensive outreach with KOLs and HCPs; Viridian participated in two major medical conferences in October, engaging in medical and scientific education with more than 500 KOLs and HCPs at these conferences. The company led and supported multiple scientific and educational activities, reinforcing Viridian’s scientific leadership and commitment to advancing care in TED. Subcutaneous VRDN-003 Topline Readout Timing Accelerated and Narrowed REVEAL-1 and REVEAL-2 Enrollment Complete. In September, the Company announced completion of enrollment in REVEAL-1 and REVEAL-2, the pivotal phase 3 clinical trials for VRDN-003 in patients with active and chronic TED, respectively. REVEAL-1 and REVEAL-2 enrolled 132 and 204 patients, respectively, exceeding their target enrollments of 117 and 195 patients, driven by strong patient demand. The REVEAL studies are assessing every-4-week and every-8-week subcutaneous dosing regimens for VRDN-003. Topline Data Readout Accelerated. Anticipate topline data from REVEAL-1 in Q1 2026 and REVEAL-2 in Q2 2026; VRDN-003 BLA submission planned for year-end 2026. Potential Best-in-Class Profile Anticipated at Launch. VRDN-003 is designed to be administered via a commercially validated, low-volume autoinjector that patients can self-administer at home. FcRn Inhibitor Portfolio Continues to Advance VRDN-006 Showed IgG Reduction Proof-of-Concept in Healthy Volunteers. In September, the company announced that VRDN-006 showed IgG reductions in its ongoing phase 1 clinical trial consistent with the FcRn inhibitor class. VRDN-006 was sparing of albumin and LDL and was generally well-tolerated, with no dose-limiting toxicities or serious adverse events. VRDN-008 IND on Track for Year-End 2025. VRDN-008 is a bi-specific half-life extended FcRn inhibitor. As previously disclosed, after a single, high dose head-to-head study in non-human primates, VRDN-008 showed a longer half-life and more sustained IgG reduction versus efgartigimod. Healthy volunteer data are expected for VRDN-008 in 2H 2026. Upcoming Investor Conferences Viridian will participate in the following upcoming investor conferences. Live webcasts of the presentation can be accessed under "Events and Presentations" on the Investors section of the Viridian website at viridiantherapeutics.com. Replays of the webcasts will be available following the conclusion of each event. Stifel 2025 Healthcare Conference: Fireside chat on Wednesday, November 12, 2025, at 9:20 a.m. ET in New York, NY Jefferies Global Healthcare Conference in London: Fireside chat on Wednesday, November 19, 2025, at 8:00 a.m. GMT (3:00 a.m. ET) in London, UK 8th Annual Evercore Healthcare Conference: Fireside chat on Thursday, December 4, 2025, at 9:35 a.m. ET in Coral Gables, FL Financial Results Cash Position: Cash, cash equivalents, and short-term investments were $490.9 million as of September 30, 2025. Preliminary cash, cash equivalents, and short-term investments were approximately $887.9 million, as of October 31, 2025. R&D Expenses: Research and development expenses were $86.3 million during the three months ended September 30, 2025, compared to $69.2 million during the three months ended September 30, 2024. The increase in research and development expenses was primarily driven by the progression of Viridian’s portfolio, including multiple ongoing phase 3 clinical trials for veligrotug and VRDN-003 and a phase 1 clinical trial for VRDN-006, as well as increased headcount. G&A Expenses: General and administrative expenses were $24.3 million during the three months ended September 30, 2025, compared to $14.4 million during the three months ended September 30, 2024. The increase was primarily due to preparatory commercial activities for veligrotug and increased headcount. Shares Outstanding: As of September 30, 2025, Viridian had 100,898,358 shares of common stock outstanding on an as-converted basis, which included 82,229,158 shares of common stock and an aggregate 18,669,200 shares of common stock issuable upon the conversion of 134,864 and 145,160 shares of Series A and Series B convertible preferred stock, respectively. About Viridian Therapeutics Viridian is a biopharmaceutical company focused on discovering, developing, and commercializing potential best-in-class medicines for patients with serious and rare diseases. Viridian’s expertise in antibody discovery and protein engineering enables the development of differentiated therapeutic candidates for previously validated drug targets in commercially established disease areas. Viridian is advancing multiple candidates in the clinic for the treatment of patients with thyroid eye disease (TED) and a portfolio of inhibitors to the neonatal Fc receptor (FcRn). In TED, the company is conducting a pivotal program for veligrotug, including two completed global phase 3 clinical trials (THRIVE and THRIVE-2), to evaluate its efficacy and safety in patients with active and chronic TED. Both THRIVE and THRIVE-2 reported positive topline data, meeting all the primary and secondary endpoints of each study. Viridian is also advancing VRDN-003 as a potential best-in-class subcutaneous therapy for the treatment of TED, including two ongoing global phase 3 pivotal clinical trials (REVEAL-1 and REVEAL-2), to evaluate the efficacy and safety of VRDN-003 in patients with active and chronic TED. In addition to its TED portfolio, Viridian is advancing a novel portfolio of FcRn inhibitors, including VRDN-006 and VRDN-008, which has the potential to be developed in multiple autoimmune diseases. Viridian is based in Waltham, Massachusetts. For more information, please visit www.viridiantherapeutics.com. Follow Viridian on LinkedIn and X. About Veligrotug Veligrotug is an intravenously delivered, anti-insulin-like growth factor-1 receptor (IGF-1R) antibody in phase 3 development for thyroid eye disease, with the potential to be the IV treatment-of-choice for active and chronic TED patients. Based on clinical data to date, veligrotug has demonstrated robust clinical activity and was generally well-tolerated. Both pivotal phase 3 clinical trials, THRIVE and THRIVE-2, reported positive topline data, meeting all the primary and secondary endpoints of each study. In these studies, veligrotug demonstrated a rapid onset of clinical benefit and statistically significant and clinically meaningful effect on multiple diplopia endpoints. This is the first data set from a global phase 3 clinical trial in chronic TED patients to demonstrate statistically significant diplopia response and resolution. About VRDN-003 VRDN-003 is a subcutaneously delivered, half-life extended, potential best-in-class anti-IGF-1R antibody. VRDN-003 has the same binding domain as veligrotug and was engineered to have a longer half-life. In a phase 1 healthy volunteer clinical trial, VRDN-003 showed a half-life of 40-50 days, 4-5x that of veligrotug. Pharmacokinetics modeling predicted that VRDN-003 exposure levels after Q4W and Q8W dosing achieve the range of veligrotug exposures that showed robust clinical activity in a two-infusion phase 2 clinical trial in TED. Viridian is conducting a pivotal program for VRDN-003, including two phase 3 clinical trials assessing VRDN-003 dosed Q4W and Q8W in active and chronic TED, REVEAL-1 and REVEAL-2, respectively. About VRDN-006 and VRDN-008 VRDN-006 is a highly selective Fc fragment which inhibits FcRn and is designed to be a convenient subcutaneous and self-administered option for patients. Viridian is studying VRDN-006 in a first-in-human phase 1 clinical trial in healthy volunteers. VRDN-008 is a half-life extended FcRn inhibitor comprising an Fc fragment and an albumin-binding domain designed to prolong IgG suppression and provide a potentially best-in-class subcutaneous option for patients. VRDN-008 showed a longer half-life than efgartigimod and led to a more sustained IgG reduction after a single, high dose head-to-head study in non-human primates. Forward Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of words such as, but not limited to, "anticipate," "believe," "become," "continue," "could," "design," "estimate," "expect," "intend," "may," "might," "on track," "plan," "potential," "predict," "project," "should," "target," "will," or "would" or other similar terms or expressions that concern our expectations, plans and intentions. Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based on our current beliefs, expectations, and assumptions. Forward-looking statements include, without limitation, statements regarding: preclinical development, clinical development, and anticipated commercialization of Viridian’s product candidates veligrotug, VRDN-003, VRDN-006, and VRDN-008; anticipated data results and timing of their disclosure, including VRDN-003 topline data from the REVEAL-1 and REVEAL-2 trials; Viridian’s expectations regarding the anticipated timing or likelihood of regulatory submissions and approvals, including the anticipated approval of the BLA for veligrotug, BLA submission for VRDN-003, MAA submission for veligrotug, and IND submission for VRDN-008; the impact of Breakthrough Therapy Designation, including eligibility for Priority Review, and the impact of Priority Review, including the potential commercial launch of veligrotug in mid-2026, if approved; the potential utility, efficacy, potency, safety, clinical benefits, clinical response, convenience, and number of indications of veligrotug, VRDN-003, VRDN-006, and VRDN-008; veligrotug’s potential to be the IV treatment-of-choice for active and chronic TED; potential market sizes and market opportunities, including for veligrotug; Viridian’s product candidates potentially being best-in-class; Viridian’s expectations regarding the potential commercialization of veligrotug and VRDN-003, if approved; Viridian’s ability to receive milestone payments pursuant to its agreement with DRI Healthcare; and that Viridian’s cash, potential near-term milestones from the royalty agreement and anticipated commercial revenues, if veligrotug and VRDN-003 are approved, will be sufficient to fund its business plans through profitability. New risks and uncertainties may emerge from time to time, and it is not possible to predict all risks and uncertainties. No representations or warranties (expressed or implied) are made about the accuracy of any such forward-looking statements. Such forward-looking statements are subject to a number of material risks and uncertainties including but not limited to: potential utility, efficacy, potency, safety, clinical benefits, clinical response, and convenience of Viridian’s product candidates; that results or data from completed or ongoing clinical trials may not be representative of the results of ongoing or future clinical trials; that preliminary data may not be representative of final data; the timing, progress and plans for our ongoing or future research, preclinical, and clinical development programs; changes to trial protocols for ongoing or new clinical trials; expectations and changes regarding the timing for regulatory filings; regulatory interactions; expectations and changes regarding the timing for enrollment and data; uncertainty and potential delays related to clinical drug development; the duration and impact of regulatory delays in our clinical programs, including as a result of a prolonged government shutdown; the timing of and our ability to obtain and maintain regulatory approvals for our therapeutic candidates, including as a result of a prolonged government shutdown; manufacturing risks; competition from other therapies or products; estimates of market size; other matters that could affect the sufficiency of existing cash, cash equivalents, and short-term investments to fund operations; our financial position; our future operating results and financial performance; Viridian’s intellectual property position; the timing of preclinical and clinical trial activities and reporting results from same; that our product candidates may not be commercially successful, if approved; and other risks described from time to time in the "Risk Factors" section of our filings with the Securities and Exchange Commission (SEC), including those described in our most recent Annual Report on Form 10-K or Quarterly Report on Form 10-Q, as applicable, and supplemented from time to time by our Current Reports on Form 8-K. Any forward-looking statement speaks only as of the date on which it was made. Neither the company, nor its affiliates, advisors, or representatives, undertake any obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise, except as required by law. These forward-looking statements should not be relied upon as representing the company’s views as of any date subsequent to the date hereof. View source version on businesswire.com: https://www.businesswire.com/news/home/20251105575655/en/ Contacts Investor & Media: Greg Rossino [email protected]

