Viridian Therapeutics, Inc. (NASDAQ: VRDN), a biopharmaceutical company focused on discovering and developing potential best-in-class medicines for se

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Viridian Therapeutics (Nasdaq: VRDN) announced a successful late‑October 2025 submission of a Biologics License Application (BLA) to the U.S. FDA for veligrotug, an IV anti‑IGF‑1R monoclonal antibody for thyroid eye disease (TED).The BLA is supported by two pivotal phase 3 trials, THRIVE and THRIVE‑2, which met all primary and secondary endpoints and showed rapid clinical benefit, including statistically significant diplopia response and resolution. Veligrotug has Breakthrough Therapy designation and Viridian requested Priority Review; FDA will decide on BLA acceptance within 60 days.

What's changed? 🚨 Breaking changes Default HiddenAct::Gelu to GeLU + tanh in favour of GeLU erf by @vrdn-23 in #753 Default GeLU implementation is now GeLU + tanh approximation instead of exact...

Lumvoa is approved and first doses began in July. The next confirmed presentation is September 8. A payer policy revision is scheduled for October 1, but is not blanket coverage. The financial picture includes preferred dilution, royalty obligations and a revenue-dependent funding outlook.