Veligrotug (formerly VRDN-001)
Viridian TherapeuticsVRDN
- Indication
- Thyroid Eye Disease
- Stage
- PDUFA
- Event
- PDUFA Approval decision
- Details
May 5, 2026 — Viridian Therapeutics, Inc. (Nasdaq: VRDN) reported first-quarter 2026 financial results and provided program updates focused on thyroid eye disease (TED) and FcRn inhibitors.
Key clinical/regulatory updates: Veligrotug (IGF‑1R antibody) is under FDA Priority Review with a PDUFA target action date of June 30, 2026; Viridian states it is “launch-ready” with commercial field teams and supply chain in place. A European Marketing Authorization Application for veligrotug was submitted in January 2026 and accepted by the EMA in February 2026. For subcutaneous elegrobart (VRDN‑003), Viridian announced positive topline Phase 3 results: REVEAL‑1 (active TED) and REVEAL‑2 (chronic TED) met primary endpoints, with proptosis responder rates at week 24 of 54%/63% (Q4W/Q8W) vs 18% placebo in active TED, and 50%/54% vs 15% placebo in chronic TED; both trials were generally well tolerated with low rates of hearing impairment. A BLA submission for elegrobart is anticipated in Q1 2027.
Financial highlights (Q1 2026): cash/cash equivalents/marketable securities $762.2M (vs $874.7M at 12/31/2025); R&D expense $77.6M; SG&A $38.7M; net loss $104.9M.
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Financial Snapshot
Market Cap
$1.7B
Price
$16.31