secwatch.observer — SEC 8-K summary ====================================== Issuer: Viridian Therapeutics, Inc.\DE (VRDN) CIK: 0001590750 Form: 8-K Filed at: 2026-06-26T22:18:31+00:00 Accession: 0001193125-26-286273 Event type: regulatory Sentiment: positive Materiality: 0.95 Item codes: 7.01, 8.01, 9.01 LLM model: deepseek-v4-flash:cloud@v2 Viridian Therapeutics receives FDA approval for Lumvoa (veligrotug-vvze) to treat thyroid eye disease -------------------------------------------------------------------------------- - Lumvoa is the first FDA-approved treatment for TED with labeling covering both active and chronic disease. - Approval supported by positive Phase 3 THRIVE and THRIVE-2 trials meeting primary and all secondary endpoints. - Lumvoa showed statistically significant improvement in diplopia response and complete resolution in active and chronic TED. - Viridian plans to launch Lumvoa immediately with a comprehensive patient support program (ViridianCares). - Company will host a conference call on June 29, 2026, at 8:00 a.m. ET to discuss the approval. Source: EDGAR index: https://www.sec.gov/Archives/edgar/data/1590750/000119312526286273/0001193125-26-286273-index.htm Primary doc: https://www.sec.gov/Archives/edgar/data/1590750/000119312526286273/d164211d8k.htm HTML page: https://secwatch.observer/filing/0001193125-26-286273 License: Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer