Biogen Inc.
SPINRAZA
Resolved
95days ago
FDA decision Β· Apr 3, 2026
What's at stake
The FDA's approval decision on SPINRAZA for its lead indication is due Apr 3, 2026. A green light opens the market; a complete response letter (CRL) usually sinks the stock.
Primary source
Β· SEC 8-K
verified 14h ago
βHigh dose regimen of SPINRAZA approved in Japan and E.U.; U.S. FDA PDUFA of April 3, 2026β