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BioXcel Therapeutics develops AI-enabled biopharmaceutical programs in neuroscience and, through its wholly owned OnkosXcel Therapeutics subsidiary, immuno-oncology. Its news centers on IGALMI, the FDA-approved sublingual film formulation of dexmedetomidine for acute agitation associated with schizophrenia or bipolar I or II disorder in adults, and on BXCL501 development across additional neuropsychiatric settings.
Recurring updates include FDA interactions and label-expansion activity for IGALMI, commercial planning for broader use settings, financial results, and capital-raising transactions. Company announcements also cover investigator-led and funded studies of BXCL501 in areas such as acute agitation in Alzheimer’s dementia, opioid withdrawal, and acute stress reactions, alongside disclosures tied to its drug re-innovation approach using big data and machine learning.
BioXcel Therapeutics (Nasdaq:BTAI) presented new Phase 3 SERENITY At-Home data on BXCL501 (sublingual dexmedetomidine) for acute agitation in bipolar disorders or schizophrenia at the 2026 ASCP meeting.
Exploratory analyses showed BXCL501 reduced agitation vs placebo across mild, moderate, and severe baseline symptoms, with the largest effect in severe episodes and benefit maintained with repeated dosing over 12 weeks. The FDA has set a PDUFA target action date of November 14, 2026 for the sNDA for IGALMI for at-home use.
BioXcel Therapeutics (Nasdaq:BTAI) reported Q1 2026 results and a business update. The FDA accepted its sNDA for IGALMI at-home use in acute agitation in bipolar disorder and schizophrenia, with a PDUFA date of November 14, 2026.
The company is evaluating strategic options for the IGALMI franchise, advancing late-stage BXCL501 programs in Alzheimer’s dementia, and reported Q1 IGALMI net revenue of $206,000, operating loss of $10.2 million, net loss of $12.7 million, and cash of $17.2 million.
BioXcel Therapeutics (Nasdaq: BTAI) will host a virtual event on April 23, 2026 at 2:00 p.m. ET to discuss its commercial launch plan for IGALMI in the at-home setting.
The presentation will outline launch strategy ahead of the November 14, 2026 PDUFA target action date and follows a market opportunity assessment that identified up to 86 million annual addressable episodes of at-home acute agitation in the U.S.
BioXcel Therapeutics (Nasdaq: BTAI) announced enrollment of first patients in a DoW-funded Phase 2a trial of BXCL501 (sublingual dexmedetomidine) for acute stress reactions (ASR) on April 8, 2026.
The double-blind, placebo-controlled UNC-led study (NCT06943404) will enroll 100 motor-vehicle-collision patients to assess symptom reduction, neurocognitive effects, and prevention of chronic posttraumatic neuropsychiatric symptoms; BioXcel is supplying study drug.
BioXcel Therapeutics (Nasdaq: BTAI) announced FDA acceptance of a supplemental New Drug Application for IGALMI for at-home treatment of agitation associated with bipolar disorders or schizophrenia. The FDA set a PDUFA target action date of November 14, 2026.
According to the company, this filing targets a potential first FDA-approved at-home option and addresses up to 86 million annual episodes while the company advances commercial and launch planning.
BioXcel Therapeutics (Nasdaq: BTAI) reported Q4 and full‑year 2025 results and progress toward potential IGALMI at‑home approval. The company submitted an sNDA in January 2026 supported by the SERENITY At‑Home Phase 3 trial and targets potential approval as early as year‑end 2026.
Full‑year 2025 net revenue from IGALMI was $642,000; cash and restricted cash totaled $28.8M at year‑end. R&D, SG&A, operating loss and net loss figures were disclosed, and commercial launch preparations continue.
BioXcel Therapeutics (Nasdaq: BTAI) closed a registered direct offering on March 11, 2026, selling 4,500,785 shares and accompanying warrants at a combined price of $1.739 per share and warrant, generating approximately $8.0 million in gross proceeds.
The Accompanying Warrants carry a $1.614 exercise price, five‑year term, and certain ownership limits; the company also reduced and extended exercise terms on previously issued warrants for which the investor paid ≈$173,000.
BioXcel Therapeutics (Nasdaq: BTAI) announced a registered direct offering to an institutional investor of 4,500,785 shares of common stock and accompanying warrants at a combined price of $1.739 per share with warrant, generating approximately $8.0 million in gross proceeds before fees.
The accompanying warrants have a $1.614 exercise price, five-year term, and the company agreed to reduce and extend exercise terms on previously issued warrants for 1,385,083 shares in exchange for approximately $173,000. Closing expected on or about March 11, 2026, with Rodman & Renshaw as placement agent.
BioXcel Therapeutics (Nasdaq: BTAI) announced positive Phase 2 topline results (Mar 5, 2026) from a NIDA-funded Columbia University-led IST of BXCL501 for opioid withdrawal during a seven-day methadone taper. The 80-patient trial reported a >30% reduction in SOWS-Gossop scores with BXCL501 240 µg BID and lower rates of orthostatic hypotension versus lofexidine (18% vs 50%, p<0.05).
BXCL501 showed no sedation in treatment arms, a favorable tolerability profile, and may offer a twice-daily orally dissolving thin-film alternative for managing withdrawal, including fentanyl/xylazine-exposed patients.
BioXcel Therapeutics (Nasdaq: BTAI) will host a virtual KOL roundtable on February 27, 2026 at 2:00 p.m. EST to discuss acute agitation in Alzheimer’s dementia and the unmet need for FDA-approved treatments.
The panel will review the potential role of BXCL501 and the company’s preparations to initiate the TRANQUILITY In-Care Phase 3 trial; a replay will be available on the company website.