Kyverna Therapeutics, Inc.
miv-cel
stiff person syndrome
Resolved
7days ago
FDA decision · Jun 30, 2026
What's at stake
The FDA's approval decision on miv-cel for stiff person syndrome is due Jun 30, 2026. A green light opens the market; a complete response letter (CRL) usually sinks the stock.
Primary source
· SEC 8-K
verified 14h ago
“File BLA for miv-cel in SPS in 1H 2026: Following positive topline data from the KYSA-8 registrational trial in SPS, Kyverna intends to submit its first BLA to the FDA in the first half of 2026.”