Welcome to our dedicated page for Bioxcel Therapeutics news (Ticker: BTAI), a resource for investors and traders seeking the latest updates and insights on Bioxcel Therapeutics stock.
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) 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.
BioXcel Therapeutics (Nasdaq: BTAI) submitted a supplemental New Drug Application (sNDA) to the U.S. FDA on January 14, 2026 seeking label expansion of IGALMI® to allow at-home (outpatient) treatment of acute agitation associated with bipolar disorders or schizophrenia without healthcare provider supervision. The sNDA is supported by the Phase 3 SERENITY At-Home safety trial, which met its primary endpoint of being well-tolerated with a safety profile consistent with the approved IGALMI label, and by positive FDA pre-sNDA feedback. The company cited a potential approval timeline as early as year-end 2026 and noted estimated U.S. patient and episode burdens.
BioXcel Therapeutics (Nasdaq: BTAI) named Mark Pavao Acting Chief Commercial Officer and plans to submit a supplemental NDA in January 2026 seeking FDA approval to expand IGALMI for at-home treatment of acute agitation in bipolar disorders and schizophrenia. The company said Mr. Pavao brings more than 30 years of CNS commercial experience to lead launch planning. BioXcel indicated a potential at-home launch as early as year-end 2026 if approved and emphasized the lack of FDA-approved at-home medicines for this indication as a market opportunity.
BioXcel Therapeutics (Nasdaq: BTAI) plans to submit a supplemental New Drug Application (sNDA) in January 2026 seeking FDA approval of IGALMI for at-home use to treat acute agitation associated with bipolar disorders or schizophrenia.
The company says it is focused on submission and launch planning and believes IGALMI could be approved as early as 2026. BioXcel positions the program as an at-home treatment option where the company states there are currently no FDA-approved options.
BioXcel Therapeutics (BTAI) is sponsoring a virtual roundtable on Dec. 8, 2025 at 10:00 a.m. EST focused on treating acute agitation linked to bipolar disorder and schizophrenia.
Hosted by journalist Anjalee Khemlani, the one-hour event features Drs. Leslie Citrome, Marc Milano, and Leon Ravin discussing the potential for safe, self‑administered at‑home treatments and shifting care outside emergency and inpatient settings. The release cites an estimated 57–77 million annual at‑home agitation episodes in the U.S. Pre-registration is available and a recording will be posted to the BioXcel Therapeutics website.
BioXcel Therapeutics (Nasdaq: BTAI) reported Q3 2025 results and late-stage program updates for BXCL501/IGALMI. The company plans an sNDA submission in early Q1 2026 seeking FDA approval for at-home use based on positive SERENITY At-Home Phase 3 safety data.
SERENITY enrolled 246 patients (2,628 episodes); no drug-related SAEs, syncopes, or falls; tolerability consistent with approved IGALMI label. TRANQUILITY In-Care Phase 3 for Alzheimer’s agitation is being prepared after FDA protocol feedback. Company cites a revised U.S. TAM of 57–77M agitation episodes annually.
Q3 financials: IGALMI revenue $98k; R&D $8.7M; operating loss $14.2M; net loss $30.9M; cash $37.3M as of Sept 30, 2025.
BioXcel Therapeutics (Nasdaq: BTAI) reported positive correlation results supporting exploratory efficacy outcomes from the SERENITY At-Home program and plans to include the data in a supplemental New Drug Application (sNDA) targeted for Q1 2026.
In a prospective, open‑label in‑clinic study of 33 patients, the modified CGI‑S (mCGI‑S) scored by patients and caregivers strongly correlated with clinician PEC scores: ρ=0.89, p<0.0001 for patients and ρ=0.88, p<0.0001 for informants. No serious adverse events were reported and safety remained consistent with the IGALMI label. Company plans to include these findings in the sNDA and present additional data at upcoming medical meetings.
BioXcel Therapeutics (Nasdaq: BTAI) will ring the Nasdaq Closing Bell on October 14, 2025 to commemorate a milestone in its neuroscience program.
CEO Vimal Mehta and company representatives will mark the event following the successful completion of the SERENITY At-Home pivotal trial for IGALMI®, highlighting the company’s focus on treating agitation associated with bipolar disorder and schizophrenia. The ceremony begins at 3:45 PM ET at Nasdaq MarketSite and will be streamed live.
BioXcel Therapeutics (Nasdaq: BTAI), an AI-focused biopharmaceutical company, has successfully regained compliance with Nasdaq's market value of listed securities (MVLS) requirements. The company had previously received a non-compliance notice on March 20, 2025, for failing to maintain an MVLS above $35.0 million for 30 consecutive business days.
Following a hearing before the Nasdaq Hearing Panel on May 1, 2025, BioXcel was granted an exception period to regain compliance. On September 17, 2025, Nasdaq confirmed the company's return to compliance with all Capital Market listing requirements, officially closing the matter.
BioXcel Therapeutics (NASDAQ: BTAI) announced positive topline exploratory efficacy data from its SERENITY At-Home Pivotal Phase 3 safety trial for BXCL501 (IGALMI®), evaluating the treatment of agitation in bipolar disorders or schizophrenia patients. The trial demonstrated significant efficacy across 2,433 treated episodes, with BXCL501 showing higher complete resolution rates compared to placebo (50% vs 33%, p.0001).Key findings include consistent benefits with repeat dosing and maintained efficacy throughout the 12-week trial period. For severe agitation episodes, 61% fully resolved with BXCL501 versus 18% with placebo. The company plans to submit a sNDA in Q1 2026 for expanded usage in outpatient settings, targeting a substantial market of 57-77M annual agitation episodes.