Viridian Therapeutics Receives FDA Priority Review for Veligrotug with Target Date of June 30, 2026
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Dec 22 2025
0mins
Viridian Therapeutics announced that the FDA has accepted the biologics license application for veligrotug for the treatment of thyroid eye disease. The application has been granted priority review, with a Prescription Drug User Fee Act target action date of June 30, 2026. Preparations are underway for veligrotug's anticipated commercial launch. The company also plans to submit a marketing authorization application to the European Medicines Agency in the first quarter of 2026.
Trade with 70% Backtested Accuracy
Stop guessing "Should I Buy VRDN?" and start using high-conviction signals backed by rigorous historical data.
Sign up today to access powerful investing tools and make smarter, data-driven decisions.
Analyst Views on VRDN
Wall Street analysts forecast VRDN stock price to rise over the next 12 months. According to Wall Street analysts, the average 1-year price target for VRDN is 41.71 USD with a low forecast of 14.20 USD and a high forecast of 61.00 USD. However, analyst price targets are subjective and often lag stock prices, so investors should focus on the objective reasons behind analyst rating changes, which better reflect the company's fundamentals.
17 Analyst Rating
17 Buy
0 Hold
0 Sell
Strong Buy
Current: 33.570
Low
14.20
Averages
41.71
High
61.00
Current: 33.570
Low
14.20
Averages
41.71
High
61.00
About VRDN
Viridian Therapeutics, Inc. is a biopharmaceutical company focused on engineering and developing potential medicines for patients with serious and rare diseases. The Company is advancing multiple candidates in the clinic for the treatment of patients with thyroid eye disease (TED). The Company is conducting two global Phase 3 clinical trials (THRIVE and THRIVE-2) to evaluate the safety and efficacy of veligrotug in patients with active and chronic TED. It is also conducting two global Phase 3 clinical trials, REVEAL-1 and REVEAL-2, to evaluate the efficacy and safety of VRDN-003 in patients. Its advanced program, veligrotug, is a differentiated humanized monoclonal antibody targeting IGF-1R intravenously administered for the treatment of TED. In addition to its TED portfolio, the Company is advancing a novel portfolio of neonatal Fc receptor (FcRn) inhibitors, including VRDN-006 and VRDN-008, which has the potential to be developed in multiple autoimmune diseases.
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
Biotech Stocks Surge in 2025 with $30.9 Billion M&A Wave
- M&A Surge: In 2025, small and mid-cap biopharma companies accounted for 57% of acquisitions by deal count, with 33 deals totaling $30.9 billion, indicating a significant recovery in market confidence despite a drop in median deal value from $516 million to $303 million.
- Shift in Investor Focus: Investor attention has shifted from GLP-1 obesity drugs to cancer and autoimmune disease treatments in 2025, particularly next-generation cell therapies, reflecting strong demand for innovative treatment options and potential growth opportunities in the biotech sector.
- Strong Clinical Data: Approximately $6 billion in acquisitions related to next-generation cell therapies occurred over the past six months, highlighting significant interest from big pharma in this niche, which could drive stock price increases for involved companies.
- Optimistic Outlook: Analysts expect increased M&A and strategic partnerships in 2026, particularly in immunology and rare diseases, with a lower interest rate environment improving funding conditions and further supporting the growth of biotech companies.
Continue Reading
Viridian Therapeutics (VRDN) Secures FDA Priority Review for Veligrotug in Thyroid Eye Disease
- FDA Priority Review: Viridian Therapeutics' Biologics License Application for Veligrotug has been accepted for priority review by the FDA, with a decision expected by June 30, 2026, which will expedite its entry into the thyroid eye disease treatment market to meet growing patient needs.
- Clinical Trial Success: Veligrotug met all primary and secondary endpoints in the THRIVE and THRIVE 2 phase 3 clinical trials, demonstrating significant improvement in chronic thyroid eye disease patients' diplopia symptoms, with rapid clinical benefits enhancing its market competitiveness.
- Breakthrough Therapy Designation: In May 2025, the FDA granted Veligrotug breakthrough therapy designation, indicating its potential in treating thyroid eye disease, which further elevates investor and market interest in the drug.
- European Market Plans: Viridian plans to submit a Marketing Authorisation Application to the European Medicines Agency in the first quarter of 2026, reflecting its strategic intent for global expansion and aiming to capture growth opportunities in international markets.
Continue Reading