BTAI PDUFA Date: IGALMI Updated August 19, 2026 ยท next FDA decision on the calendar FDA decision (PDUFA) target Nov 14, 2026 · BioXcel Therapeutics · At-home agitation in bipolar disorder or schizophrenia (sNDA)
Key facts FDA PDUFA target date 2026-11-14
Drug / candidate IGALMI (dexmedetomidine sublingual film)
Indication At-home agitation in bipolar disorder or schizophrenia (sNDA)
Company BioXcel Therapeutics
Market-cap tier Nano
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See the full 2026 PDUFA calendar → All November 2026 PDUFA dates → FAQ When is the BTAI PDUFA date? The FDA PDUFA target date for BTAI (BioXcel Therapeutics) is 2026-11-14 for IGALMI (dexmedetomidine sublingual film). Dates are company/FDA-sourced and can slip. Verify against primary filings.
What is BTAI's drug IGALMI? IGALMI (dexmedetomidine sublingual film) is BioXcel Therapeutics's candidate under FDA review for At-home agitation in bipolar disorder or schizophrenia (sNDA).
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