WALTHAM, Mass. — 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 announced that the U.S. Food and Drug Administration (FDA) has accepted the Biologics License Application (BLA) for veligrotug for the treatment of thyroid eye disease (TED). The application has been granted Priority Review, with a Prescription Drug User Fee Act (PDUFA) target action date of June 30, 2026.
Priority Review shortens the BLA target review timeline to six months from ten 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. Priority Review is the second FDA designation granted for veligrotug in 2025. In May 2025, the agency granted veligrotug Breakthrough Therapy Designation. Each of these requests included phase 3 clinical trial data on veligrotug’s (i) consistent and robust improvement and resolution of diplopia in chronic TED, and (ii) rapid onset of proptosis response.
“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. “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 veligrotug BLA is supported by positive data from two of the largest phase 3 clinical trials conducted in TED to date. In THRIVE and THRIVE‑2, conducted in active and chronic TED patients, respectively, veligrotug met the primary and all secondary endpoints of each study as well as demonstrated a rapid onset of clinical benefit. For the first time in a phase 3 clinical trial in chronic TED, veligrotug demonstrated statistically significant diplopia response and diplopia resolution. Veligrotug, if approved, would provide patients with an attractive treatment option with a five-infusion treatment course enabling patients to complete treatment in 12 weeks. Veligrotug was generally well-tolerated in its phase 3 clinical trials.
Preparations are well 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.
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 the primary and all secondary endpoints of each study. In these studies, veligrotug demonstrated a rapid onset of clinical benefit and statistically significant, clinically meaningful effects on multiple diplopia endpoints in both clinical trials, including the first demonstration of diplopia response and resolution in a global chronic TED phase 3 study. Following these results, veligrotug was granted Breakthrough Therapy Designation in May 2025. The FDA also granted the veligrotug BLA a Priority Review with a PDUFA target action date of June 30, 2026. Both Breakthrough Therapy and Priority Review Designations were supported by phase 3 clinical trial data on veligrotug’s consistent and robust improvement and resolution of diplopia in chronic TED, and rapid onset of proptosis response.
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). The company conducted a pivotal program for veligrotug (VRDN-001), 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 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 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.
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