Catalyst overview
Research summary
This catalyst tracks a Approved update for VYVGART (IV: Efgartigimod alfa-fcab) in AChR-Ab seronegative Myasthenia gravis. The expected timing is based on the latest available company guidance and may change.
ADAPT SERON Ph3 Study. 8/25/25- Announces positive topline results. sBLA submission by YE 2025. Presentation at AANEM'25 on October 29th. 01/12/26:- sBLA submitted for seronegative gMG; if approved, launch expected by end of 2026. 01/13/26:- FDA accepted sBLA with Priority Review for seronegative gMG; PDUFA decision due May 10, 2026. 03/06/26:- ADAPT SERON initial results to be presented at AAN on Apr 20, 2026. 04/18/26:- ADAPT SERON OLE showed improving MG-ADL and QMG with cycles. PDUFA May 10, 2026. 05/08/26:- FDA approved expanded gMG label to include all adult serotypes.
Verification
Confirm timing and program details against the company announcement or filing.