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Home › PDUFA Calendar › BTAI

BTAI PDUFA Date: IGALMI® (dexmedetomidine)

Updated ·next FDA decision on the calendar
FDA decision (PDUFA) target 2026-11-14 · BioXcel Therapeutics Inc. · Agitation associated with bipolar I or II disorder or schizophrenia
More CNS & Neurology FDA decisions →All November 2026 PDUFA dates →

The story

IGALMI® (dexmedetomidine) is under FDA review to treat acute agitation in bipolar I/II disorder (a dissolvable film of dexmedetomidine). Balance sheet: about 4 months of cash, runway ~4 mo (estimated). HIGH: runway ends before this catalyst
Full PDUFA calendar ->Every upcoming FDA decision date, by monthNRXP . 2026-07-29Same area: Neurology . KETAFREELNTH-florquinitau . 2026-08-13Same area: Neurology . Florquinitau (MK-6240)SMMT . 2026-11-14Same month decision . Ivonescimab plus platinum-doublet chem
Plain-English summary compiled by pdufa.bio from public FDA, SEC and company sources. Informational only - not investment advice.

BTAI run-up into the PDUFA (last ~120 days)

$1.76$1.02
Price path to 2026-06-19. Green = local high, red = low/sell-off. Historical price action, not a forecast.

Key facts

FDA PDUFA target date2026-11-14
Drug / candidateIGALMI® (dexmedetomidine)
IndicationAgitation associated with bipolar I or II disorder or schizophrenia
CompanyBioXcel Therapeutics Inc.
Market-cap tierNano
Cohort decision-day move (history)±?% median
ClinicalTrials.govNCT05658510

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FAQ

When is the BTAI PDUFA date?
The FDA PDUFA target date for BTAI (BioXcel Therapeutics Inc.) is 2026-11-14 for IGALMI® (dexmedetomidine). Dates are company/FDA-sourced and can slip. Verify against primary filings.
What is BTAI's drug IGALMI® (dexmedetomidine)?
IGALMI® (dexmedetomidine) is BioXcel Therapeutics Inc.'s candidate under FDA review for Agitation associated with bipolar I or II disorder or schizophrenia.
What typically happens to a nano-cap stock into a PDUFA date?
Historically, nano-cap names had a median decision-day move around ±?% (763-PDUFA cohort, 2024-26). This is historical context by market-cap tier, not a prediction for this drug.
Decision-day move · nano-cap cohortn=116 · median -0.1% · 47% up
under -30%: 8 of 116 (7%)<-30-30 to -15%: 10 of 116 (9%)-15 to -7%: 14 of 116 (12%)-7 to -3%: 7 of 116 (6%)-3 to +3%: 33 of 116 (28%)±3+3 to +7%: 13 of 116 (11%)+7 to +15%: 12 of 116 (10%)+15 to +30%: 14 of 116 (12%)over +30%: 3 of 116 (3%)>+30
Distribution of next-day % moves after the FDA decision for nano-cap PDUFAs (2020–26). Red = down, green = up, blue = flat (±3%). Historical dispersion, not a forecast.