This section highlights FDA-related milestones and regulatory updates for drugs developed by Viridian Therapeutics (VRDN).
Over the past two years, Viridian Therapeutics has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
Veligrotug, VRDN-001, VRDN-003, and VRDN-006. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
Veligrotug - FDA Regulatory Timeline and Events
Veligrotug is a drug developed by Viridian Therapeutics for the following indication: For Chronic Thyroid Eye Disease.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- Veligrotug
- Announced Date:
- May 20, 2025
- Indication:
- For Chronic Thyroid Eye Disease
Announcement
Viridian Therapeutics, Inc announced positive long-term durability data from the THRIVE phase 3 clinical trial of veligrotug ("veli"), an intravenously delivered anti-insulin-like growth factor-1 receptor (IGF-1R) antibody, in patients with active thyroid eye disease (TED).
AI Summary
Viridian Therapeutics announced promising long-term results from its THRIVE Phase 3 trial of veligrotug, an intravenously delivered anti-IGF-1R antibody for active thyroid eye disease (TED). In the study, 70% of patients who responded to treatment with a reduction in eye bulging at week 15 maintained that improvement through week 52. This durability data highlights the lasting effect of veligrotug, with most side effects observed earlier having resolved by the end of the study. The consistent safety profile and robust clinical performance support its potential as a leading treatment option for TED. Based on these encouraging results, the company is advancing towards a Biologics License Application, scheduled for the second half of 2025, and is preparing for a potential U.S. commercial launch in 2026.
Read Announcement- Drug:
- Veligrotug
- Announced Date:
- February 27, 2025
- Indication:
- For Chronic Thyroid Eye Disease
Announcement
Viridian Therapeutics, Inc reported recent business highlights
AI Summary
Viridian Therapeutics, Inc. announced several business highlights, particularly regarding its thyroid eye disease (TED) programs. The company reported positive phase 3 topline data for its lead TED treatment, veligrotug, from the THRIVE and THRIVE-2 trials. Veligrotug met all required endpoints in both active and chronic TED patients, showing rapid treatment effects with fewer infusions, and it has the potential to become a new standard of care. The Biologics License Application (BLA) for veligrotug is on track for submission in the second half of 2025. Additionally, Viridian’s REVEAL-1 and REVEAL-2 phase 3 trials are progressing as planned, with topline data expected in the first half of 2026 for the subcutaneous therapy VRDN-003. The company also shared updates on its FcRn inhibitor programs and strengthened its financial position with $717.6 million in cash, ensuring funds into mid-2027.
Read Announcement- Drug:
- Veligrotug
- Announced Date:
- December 16, 2024
- Indication:
- For Chronic Thyroid Eye Disease
Announcement
Viridian Therapeutics, Inc announced positive topline data from the THRIVE-2 phase 3 clinical trial of veligrotug (veli), an intravenously (IV) delivered anti-insulin-like growth factor-1 receptor (IGF-1R) antibody, in patients with chronic thyroid eye disease (TED).
AI Summary
Viridian Therapeutics, Inc. announced positive topline results from its global phase 3 THRIVE-2 clinical trial evaluating veligrotug, an intravenously delivered anti-IGF-1R antibody for chronic thyroid eye disease (TED). The study met all primary and secondary endpoints, showing statistically significant improvements in key disease symptoms. At week 15, 56% of patients achieved a proptosis response with rapid onset observed after just one infusion. Additionally, 56% of study participants experienced a reduction in diplopia, with 32% achieving complete resolution, demonstrating veligrotug’s effective impact on double vision in chronic TED patients.
The treatment was generally well-tolerated, with 94% of patients completing the regimen and a low incidence of adverse events. These promising results support veligrotug’s potential as a transformative therapy for TED and pave the way for its upcoming Biologics License Application submission in the second half of 2025.
Read Announcement
VRDN-001 - FDA Regulatory Timeline and Events
VRDN-001 is a drug developed by Viridian Therapeutics for the following indication: Thyroid Eye Disease (TED).
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- VRDN-001
- Announced Date:
- September 10, 2024
- Indication:
- Thyroid Eye Disease (TED)
Announcement
Viridian Therapeutics, Inc nnounced positive topline data from the THRIVE phase 3 clinical trial of VRDN-001, now known as veligrotug, an intravenously delivered anti-insulin-like growth factor-1 receptor (IGF-1R) antibody, in patients with active thyroid eye disease (TED).
AI Summary
Viridian Therapeutics, Inc. announced positive topline results from its THRIVE phase 3 clinical trial for veligrotug (formerly VRDN-001), an intravenously delivered anti-IGF-1R antibody aimed at treating active thyroid eye disease (TED). In the largest phase 3 study to date for an anti-IGF-1R treatment in TED, veligrotug achieved all primary and secondary endpoints at week 15 after a regimen of five infusions. The trial showed a 70% proptosis responder rate (64% placebo-adjusted) and demonstrated clinically significant improvements, including complete resolution of diplopia in 54% of patients and marked reductions in the Clinical Activity Score. Veligrotug also showed a rapid onset of action with more than half of the patients reporting benefits after just one infusion. Additionally, the treatment was well-tolerated, with no treatment-related serious adverse events observed, highlighting its potential as a convenient and effective option for TED patients.
Read Announcement- Drug:
- VRDN-001
- Announced Date:
- September 9, 2024
- Indication:
- Thyroid Eye Disease (TED)
Announcement
Viridian Therapeutics, Inc. to report topline data for the THRIVE phase 3 clinical trial, evaluating VRDN-001 in patients with active TED, on Tuesday, September 10, 2024 at 8:00am ET.
AI Summary
Viridian Therapeutics, Inc. will announce its topline data for the THRIVE Phase 3 clinical trial on Tuesday, September 10, 2024, at 8:00 a.m. ET. This trial is designed to evaluate the efficacy and safety of VRDN-001 in patients with active thyroid eye disease (TED). The company is holding a conference call and webcast on the same day to discuss the results.
Interested parties can access the webcast via the “Events and Presentations” section on Viridian’s website at viridiantherapeutics.com. To join the conference call, participants may dial 800-715-9871 for domestic access or 646-307-1963 for international participation, using the reference code 8636908. A replay of the webcast will also be available after the event.
Read Announcement- Drug:
- VRDN-001
- Announced Date:
- July 25, 2024
- Estimated Event Date Range:
- October 1, 2024 - December 31, 2024
- Target Action Date:
- 2024-LATE
- Indication:
- Thyroid Eye Disease (TED)
Announcement
Viridian Therapeutics, Inc announced that THRIVE-2 topline readout on track for year-end 2024 -
AI Summary
Viridian Therapeutics, Inc. announced that the topline data readout for its THRIVE-2 clinical trial is on track for year-end 2024. The phase 3 trial, which focuses on the safety and efficacy of VRDN-001 for patients with chronic thyroid eye disease (TED), successfully enrolled 188 patients globally, surpassing its target of 159 patients. Significantly, around 40% of the participants were from US sites, reflecting strong patient interest and demand.
The company is encouraged by the robust enrollment numbers, which support the potential of VRDN-001 as a viable treatment option for chronic TED. Viridian's progress in THRIVE-2 reinforces its commitment to developing best-in-class therapies for serious diseases, and the upcoming topline readout at the end of this year is highly anticipated by researchers, clinicians, and investors alike.
Read Announcement- Drug:
- VRDN-001
- Announced Date:
- July 25, 2024
- Estimated Event Date Range:
- September 1, 2024 - September 30, 2024
- Target Action Date:
- September 1, 2024
- Indication:
- Thyroid Eye Disease (TED)
Announcement
Viridian Therapeutics, Inc announced that THRIVE topline readout in patients with active TED on track for September 2024 -
AI Summary
Viridian Therapeutics, Inc. announced that the topline data readout for its THRIVE study in patients with active thyroid eye disease (TED) is on track for September 2024. This trial is part of the company’s Phase 3 program assessing VRDN-001, an intravenously administered monoclonal antibody targeting the IGF-1 receptor, a validated target for TED. The positive outlook comes as the THRIVE-2 study for patients with chronic TED has exceeded its enrollment target, with 188 patients enrolled worldwide, including about 40% from the United States. While the THRIVE-2 topline readout is expected by the end of 2024, the active TED data from the THRIVE trial will be available in September 2024. These milestones underline strong patient interest and suggest promising potential for VRDN-001 in improving treatment options for TED.
Read Announcement- Drug:
- VRDN-001
- Announced Date:
- July 25, 2024
- Indication:
- Thyroid Eye Disease (TED)
Announcement
Viridian Therapeutics, Inc announced that enrollment is complete in THRIVE-2, its phase 3 clinical trial for VRDN-001 in patients with chronic TED.
AI Summary
Viridian Therapeutics, Inc. announced that enrollment is complete for THRIVE-2, its phase 3 clinical trial evaluating VRDN-001 in patients with chronic thyroid eye disease (TED). The trial exceeded its enrollment target by enrolling 188 patients, well above the planned 159, with approximately 40% of participants coming from U.S. sites. This strong patient demand highlights significant interest in the treatment.
Topline data from the THRIVE-2 trial is expected to be available by the end of 2024. The company’s focus on VRDN-001 aims to provide a more convenient intravenous treatment option with a shorter infusion time and fewer infusions compared to existing therapies. The successful enrollment in THRIVE-2 marks an important milestone as Viridian moves forward with its clinical development plans for treating chronic TED.
Read Announcement
VRDN-003 - FDA Regulatory Timeline and Events
VRDN-003 is a drug developed by Viridian Therapeutics for the following indication: for patients with moderate-to-severe TED.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- VRDN-003
- Announced Date:
- June 11, 2024
- Indication:
- for patients with moderate-to-severe TED.
Announcement
Viridian Therapeutics, Inc today reported details of its plans to initiate a phase 3 clinical trial program for its SC VRDN-003 product candidate for patients with moderate-to-severe TED.
AI Summary
Viridian Therapeutics, Inc. announced plans to launch a phase 3 clinical trial program for its subcutaneously administered VRDN-003, aimed at treating patients with moderate-to-severe thyroid eye disease (TED). The company will start two randomized, double-masked, placebo-controlled trials, REVEAL-1 and REVEAL-2, in August 2024. These trials will compare two active dosing regimens, one with injections every 4 weeks and another every 8 weeks, with an initial 600mg loading dose followed by regular doses. The main goal is to improve proptosis by at least 2mm after 24 weeks, and topline data from both studies is expected in the first half of 2026. Additionally, Viridian plans to file a Biologics License Application for VRDN-003 by the end of 2026. This product candidate is unique due to its longer half-life, potentially allowing for fewer injections and a more convenient treatment option for patients with TED.
Read Announcement
VRDN-006 - FDA Regulatory Timeline and Events
VRDN-006 is a drug developed by Viridian Therapeutics for the following indication: a neonatal Fc receptor.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- VRDN-006
- Announced Date:
- January 8, 2025
- Indication:
- a neonatal Fc receptor
Announcement
Viridian Therapeutics, Inc announces the company's key priorities and catalysts for 2025.
AI Summary
Viridian Therapeutics has set out its key priorities and catalysts for 2025. The company aims to submit a Biologics License Application (BLA) for its lead candidate, veligrotug, in the second half of 2025 after demonstrating positive phase 3 topline data in treatment of both active and chronic thyroid eye disease (TED). Simultaneously, Viridian is advancing its subcutaneous product, VRDN-003, with two phase 3 trials (REVEAL-1 and REVEAL-2) currently enrolling, and anticipates topline data in the first half of 2026 followed by a BLA submission later that year.
Additionally, the firm is progressing its FcRn inhibitor portfolio. It expects proof-of-concept clinical data for VRDN-006 by Q3 2025 and further preclinical data for VRDN-008, with a planned Investigational New Drug (IND) submission by the end of 2025. These efforts are supported by a strong cash position to fuel development into 2027.
Read Announcement
