Lumvoa (veligrotug-vvze) - (THRIVE)

January 6, 2026: Viridian Therapeutics, Inc. (NASDAQ: VRDN) outlined 2026 catalysts across its thyroid eye disease (TED) and FcRn portfolios. The FDA accepted the BLA for veligrotug (IGF‑1R inhibitor) for TED and granted Priority Review with a PDUFA target action date of June 30, 2026; the BLA was submitted in October 2025 and is supported by Phase 3 THRIVE (active TED) and THRIVE‑2 (chronic TED), which the company says reported positive topline data meeting primary and all secondary endpoints. Viridian is preparing commercially for a potential mid‑2026 U.S. launch if approved and plans to submit an EMA MAA in Q1 2026.

For subcutaneous elegrobart (VRDN‑003), Phase 3 REVEAL‑1 (active TED) topline results are expected in Q1 2026 and REVEAL‑2 (chronic TED) in Q2 2026; enrollment completed in 2025.

Pipeline additions/updates: a new TSHR inhibitor program with an IND expected in Q4 2026; VRDN‑008 (bi‑specific, half‑life extended FcRn inhibitor) IND submitted in December 2025 with Phase 1 healthy volunteer data expected in 2H 2026; VRDN‑006 Phase 1 healthy volunteer data showed IgG reduction proof‑of‑concept, with 2026 development plans to be communicated. Cash and investments were approximately $888 million as of Oct. 31, 2025.