Catalyst overview
Research summary
This catalyst tracks a Approved update for Veligrotug (formerly VRDN-001) in Thyroid Eye Disease . The expected timing is based on the latest available company guidance and may change.
Suspected mover: Ph1-2/THRIVE-2 Ph3 studies in Chronic TED. 12/16/24- Met all primary & secondary endpoints. 11/3/25- BLA submitted to FDA in late October. 12/22/25:- FDA accepted BLA, granted Priority Review; PDUFA target June 30, 2026; EMA MAA planned Q1 2026. 02/26/26:- EMA MAA submitted Jan 2026; BLA Priority Review ongoing; US launch prep on track mid-2026. 05/05/26:- PDUFA June 30, 2026 reiterated; launch infrastructure ready; EMA MAA accepted for review February 2026. 06/29/26:- FDA approved Lumvoa for active and chronic thyroid eye disease; launch begins immediately. 08/06/26:- Lumvoa launch began; first doses given in July with broad demand.
Verification
Confirm timing and program details against the company announcement or filing.