BioXcel Therapeutics, Inc.

0 products tracked · names used in filings: BioXcel Therapeutics, Inc.

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Sat 14 Nov 2026🇺🇸 PDUFA datecompany-announcedtoday

IGALMI: PDUFA target action date (acute treatment of agitation associated with bipolar disorders or schizophrenia in the at-home (outpatient) setting)

BioXcel Therapeutics, Inc. (BTAI); dexmedetomidine; sNDA; status: set; "In the quarter ended on March 31, the FDA accepted the Company’s supplemental New Drug Application (sNDA) for IGALMI® for at-home use in the acute treatment of agitation associated with bipolar disorders or schizophrenia and assigned a PDUFA target action date of November 14, 2026."; filed 2026-05-15 · source

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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.