BLA accepted, priority review granted by US FDA for Viridian Viridian Therapeutics’ veligrotug

The US FDA has accepted biotechnology company Viridian Therapeutics’ biologics license application (BLA) for veligrotug for the treatment of thyroid eye disease (TED), as announced by the company.¹ The application has been granted priority review and has a prescription drug user fee act (PDUFA) target action date of June 30, 2026, according to a news release.

“We are thrilled that the FDA granted Priority Review for veligrotug, marking another significant milestone for Viridian and the TED community,” said Steve Mahoney, Viridian’s president and CEO, in the release. “This designation is a recognition that, if approved, veligrotug would be a significant improvement in the safety or effectiveness of treating a serious condition. This achievement also reflects the Viridian team’s excellent execution and dedication. We very much appreciate all of the support we’ve received from patients, investigators, and our clinical partners. We look forward to working closely with the FDA as we advance toward our goal of delivering a potentially transformative therapy to people living with thyroid eye disease and establishing Viridian as a leading commercial company in TED.”

The priority review works by shortening the BLA target review timeline from 10 months to 6 months after the FDA accepts the BLA. “This 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,” the release stated. The more recent priority review is the second FDA designation that has been granted for veligrotug in 2025. The FDA previous granted the drug breakthrough therapy designation in May 2025.¹

Each request included phase 3 clinical trial data on the drug’s “consistent and robust improvement and resolution of diplopia in chronic TED, and rapid onset of proptosis response,” according to the release. The current BLA is supported by positive data from 2 of the largest phase 3 trials conducted in TED to date: the THRIVE and THRIVE-2 trials. In assessing veligrotug’s administration in active and chronic TED patients, the drug met the primary and all secondary end points and “demonstrated a rapid onset of clinical benefit.” Veligrotug was also found to have a statistically significant diplopia response and diplopia resolution for the first time in a phase 3 clinical trial in chronic TED. The drug was well-tolerated in all phase 3 trials.¹

“We are thrilled that the FDA granted priority review for veligrotug, marking another significant milestone for Viridian and the TED community,” said Mahoney in the release. “This designation is a recognition that, if approved, veligrotug would be a significant improvement in the safety or effectiveness of treating a serious condition. This achievement also reflects the Viridian team’s excellent execution and dedication. We very much appreciate all of the support we’ve received from patients, investigators, and our clinical partners. We look forward to working closely with the FDA as we advance toward our goal of delivering a potentially transformative therapy to people living with thyroid eye disease and establishing Viridian as a leading commercial company in TED.”

If approved, veligrotug would be administered with a 5-infusion treatment course and would allow patients to complete their treatment in 12 weeks. Viridian is currently preparing for the drug’s anticipated commercial launch and to submit a marketing authorization application to the European Medicines Agency in Q1 2026.¹ Additionally, Viridian partnered with Kissei Pharmaceutical in August 2025 to advance thyroid eye disease therapies in Japan, which includes veligrotug and VRDN-003.²

References

1. Viridian Therapeutics announces BLA acceptance and priority review of veligrotug for the treatment of thyroid eye disease. News release. Businesswire. December 22, 2025. Accessed Decemeber 22, 2025. https://www.businesswire.com/news/home/20251222159703/en/Viridian-Therapeutics-Announces-BLA-Acceptance-and-Priority-Review-for-Veligrotug-for-the-Treatment-of-Thyroid-Eye-Disease

2. Lewis A. Viridian partners with Kissei Pharmaceutical to advance thyroid eye disease therapies in Japan. Optometry Times. August 4, 2025. Accessed December 22, 2025. https://www.optometrytimes.com/view/viridian-partners-with-kissei-pharmaceutical-advance-thyroid-eye-disease-therapies-japan