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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) 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.
BioXcel Therapeutics (Nasdaq: BTAI) completed an updated market opportunity assessment for IGALMI in the at-home treatment of acute agitation related to bipolar disorder or schizophrenia.
The study estimated ~2.3 million treated patients with up to 1.8 million eligible and as many as 86 million annual addressable episodes; an sNDA for at-home use was submitted in January 2026.