VRDN-001 - (THRIVE)

December 22, 2025: Viridian Therapeutics, Inc. (NASDAQ: VRDN) said the FDA accepted its Biologics License Application (BLA) for veligrotug (VRDN-001) to treat thyroid eye disease (TED) and granted Priority Review, setting a PDUFA target action date of June 30, 2026. The company noted Priority Review shortens the review timeline to six months from 10 months post-acceptance. Veligrotug previously received Breakthrough Therapy Designation in May 2025; both requests included Phase 3 data citing consistent improvement/resolution of diplopia in chronic TED and rapid proptosis response.

The BLA is supported by two Phase 3 trials: THRIVE (active TED) and THRIVE‑2 (chronic TED), where veligrotug met the primary and all secondary endpoints and showed rapid onset of clinical benefit. The release highlights statistically significant diplopia response and diplopia resolution in chronic TED (stated as a first in a Phase 3 chronic TED trial). Veligrotug was generally well tolerated; the proposed regimen is five infusions over 12 weeks.

Viridian plans to submit an EMA Marketing Authorization Application in Q1 2026. The company also noted ongoing Phase 3 trials of VRDN-003 (REVEAL-1 and REVEAL-2) in active and chronic TED.