Catalyst overview
Research summary
This catalyst tracks a PDUFA approval decision for Cemdisiran in Myasthenia gravis. The expected timing is based on the latest available company guidance and may change.
NIMBLE Ph3 trial. 8/27/25- Met primary & secondary endpoints. Regulatory submission in Q1 2026. 04/21/26:- NIMBLE Ph3 results published and presented at AAN. U.S. regulatory application submitted in Q1 2026. 06/22/26:- FDA accepted NDA; PDUFA action date November 2026. EU decision expected H2 2027.
Verification
Confirm timing and program details against the company announcement or filing.