BioXcel Therapeutics, Inc.
IGALMI
agitation associated with bipolar disorders or schizophrenia
Countdown
130days
FDA decision · Nov 14, 2026
What's at stake
The FDA's approval decision on IGALMI for agitation associated with bipolar disorders or schizophrenia is due Nov 14, 2026. A green light opens the market; a complete response letter (CRL) usually sinks the stock.
Primary source
· SEC 8-K
verified 15h ago
“FDA accepted the Company’s sNDA for IGALMI use in at-home (outpatient) setting; set Nov. 14, 2026, as PDUFA date”