- Veligrotug BLA accepted for thyroid eye disease (TED) with PDUFA target action date of June 30, 2026 under Priority Review; commercial preparations on track -
- Topline phase 3 results for subcutaneous elegrobart (VRDN-003) on track for Q1 2026 for REVEAL-1 and Q2 2026 for REVEAL-2 for active and chronic TED, respectively -
- IND submitted for half-life extended FcRn-inhibitor, VRDN-008; healthy volunteer (HV) data expected in 2H 2026 -
- Unveiling new program targeting thyroid-stimulating hormone receptor (TSHR); IND expected Q4 2026 -
- Cash position of approximately $888 million as of October 31, 2025 -
- Company expects its current business plans to be funded through profitability -
Viridian Therapeutics, Inc. (NASDAQ:VRDN), a biotechnology company focused on discovering, developing and commercializing potential best-in-class medicines for serious and rare diseases, today announces the company's key priorities and anticipated catalysts for 2026.
"Following another year of strong execution across our portfolio, we enter 2026 positioned for meaningful value-creation and progress," said Steve Mahoney, President and Chief Executive Officer of Viridian. "The FDA's acceptance of the veligrotug BLA under Priority Review underscores the need for additional treatment options in TED and reinforces our conviction in veligrotug's strong clinical profile. Our priorities this year are clear: deliver pivotal topline data for elegrobart in Q1 and Q2, prepare for a potential mid‑year approval and launch of veligrotug, and advance our broader pipeline throughout with disciplined execution to create long-term value for patients and shareholders."
IGF‑1R Inhibitor Portfolio for TED Positioned for Transformational Impact in 2026
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Veligrotug BLA granted Priority Review; Prescription Drug User Fee Act (PDUFA) target date June 30, 2026
- The veligrotug BLA, submitted in October 2025, is supported by positive data from two of the largest phase 3 clinical trials conducted in TED to date, THRIVE and THRIVE‑2 in active and chronic TED, respectively.
- 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.
- Priority Review designation is granted to applications for drugs that, if approved, would be a significant improvement in the safety or effectiveness of treating a serious condition.
- Commercial and field medical affairs preparation continues in anticipation of a potential mid‑2026 U.S. launch. Sales, market access, patient services, and medical affairs leadership teams have been in place, and engagement is ongoing with a target core prescriber base of ~2,000 physicians in the annualizing $2 billion U.S. TED market.
- Viridian is on track to submit a Marketing Authorization Application (MAA) to the European Medicines Agency in Q1 2026.
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Subcutaneous elegrobart (VRDN‑003) topline data on track for Q1 and Q2 2026
- Topline data are expected in Q1 2026 for REVEAL‑1 (active TED) and Q2 2026 for REVEAL‑2 (chronic TED).
- Enrollment in REVEAL‑1 and REVEAL‑2 completed in 2025, with each study exceeding target enrollment due to strong patient demand; the majority of patients in both studies were enrolled in the U.S.
- Elegrobart is being developed as a potential best-in-class subcutaneous anti-IGF-1R therapy for self-administration at home in a low‑volume autoinjector, with every-4-week or every-8-week dosing.
- Elegrobart is expected to be the only autoinjector for TED available at the time of anticipated launch.
- Commercial infrastructure for veligrotug launch is expected to lay the groundwork for and to accelerate launch planning for elegrobart.
Expanding Viridian's TED Pipeline with Potential Best-in-Class TSHR Program
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Announcing new TSHR inhibitor program with IND expected in Q4 2026
- Viridian is advancing a potential best-in-class, half-life extended, monoclonal antibody that inhibits TSHR, designed for subcutaneous delivery in an autoinjector with the potential to support extended dosing intervals designed for patient convenience.
- Viridian expects to submit an IND for this program in Q4 2026.
FcRn Portfolio Continues to Advance
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VRDN-006 achieved IgG reduction proof-of-concept in healthy volunteers
- As previously disclosed, phase 1 healthy volunteer data demonstrated proof‑of‑concept IgG reduction in line with the FcRn inhibitor class and spared albumin and LDL. VRDN-006 was generally well-tolerated.
- Viridian expects to communicate development plans for VRDN-006 in 2026.
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VRDN-008 IND submitted in December 2025; phase 1 HV data expected in 2H 2026
- IND was submitted in December 2025; healthy volunteer data are expected in 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.
Well-Capitalized to Deliver on Priorities Through Profitability
- Viridian ended October 2025 with approximately $888 million in cash and investments.
- 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.
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 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 or 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: Viridian's expectation that 2026 will be transformational; Viridian's expectation for its current business plans to be funded through profitability; preclinical development, clinical development, and anticipated commercialization of Viridian's product candidates veligrotug, elegrobart (formerly VRDN-003), VRDN-006, VRDN-008, and the TSHR inhibitor; anticipated data results and timing of their disclosure, including VRDN-003 topline data from the REVEAL-1 and REVEAL-2 trials in the first half of 2026 and VRDN-008 phase 1 healthy volunteer data in the second half of 2026; regulatory interactions and anticipated timing of regulatory submissions, including the anticipated MAA submission to the European Medicines Agency in the first quarter of 2026, and IND submission for the TSHR product candidate by year-end 2026, the PDUFA target action date based on Priority Review, and any other FDA designations; the potential utility, efficacy, potency, safety, clinical benefits, clinical response, convenience, and number of indications of veligrotug, elegrobart, VRDN-006, VRDN-008, and a TSHR product candidate; veligrotug's potential to be the IV treatment-of-choice for active and chronic TED; the potential of veligrotug and VRDN-003 to establish a standard of care for patients; potential market sizes and market opportunities for Viridian's product candidates, including Viridian's beliefs regarding the strength of patient demand for VRDN-003 and its ability to expand the TED commercial market; Viridian's product candidates potentially being best-in-class, including Viridian's view of VRDN-003 as a potential best-in-class subcutaneous therapy for the treatment of TED; Viridian's expectations regarding the potential commercialization of veligrotug and VRDN-003, if approved, including the potential U.S. launch of veligrotug in mid-2026 if approved under Priority Review and plans to launch VRDN-003 with a low-volume autoinjector; the potential for elegrobart to be the only available autoinjector for TED available at the time of its potential launch; and the potential for the commercial infrastructure for veligrotug launch to lay the groundwork for and to accelerate launch planning for elegrobart.
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; 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 and projected cash runway; 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.
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