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, Inc. (Nasdaq: BTAI) is a biopharmaceutical company that uses artificial intelligence, big data, and proprietary machine learning algorithms to develop medicines in neuroscience. News about BioXcel Therapeutics often centers on its commercial product IGALMI (dexmedetomidine) sublingual film and its investigational program BXCL501 for the acute treatment of agitation associated with schizophrenia, bipolar disorders, and Alzheimer’s dementia.
Investors and clinicians following BTAI news can expect updates on late‑stage clinical programs such as the SERENITY At‑Home Pivotal Phase 3 trial, which evaluated the safety of a 120 mcg dose of BXCL501 for at‑home treatment of agitation in bipolar disorders or schizophrenia, and the TRANQUILITY In‑Care Phase 3 trial, designed to study agitation associated with Alzheimer’s dementia in care facilities. Company announcements have highlighted that SERENITY At‑Home met its primary safety endpoint and reported exploratory efficacy findings related to repeated dosing and symptom resolution across thousands of agitation episodes.
BioXcel Therapeutics’ news flow also includes regulatory and development milestones, such as plans to submit a supplemental New Drug Application (sNDA) seeking FDA approval for IGALMI use in the at‑home setting, positive correlation study results supporting the use of the modified CGI‑S scale, and presentations of clinical data at medical conferences. Corporate updates, including financing activities under an at‑the‑market equity program, Nasdaq listing compliance notices, and leadership or governance developments, are typically disclosed through SEC filings and press releases.
This news page aggregates these company‑specific developments so readers can review BioXcel Therapeutics’ clinical, regulatory, and corporate announcements over time. For those tracking BTAI, it provides a focused view of how the IGALMI and BXCL501 programs, as well as the broader pipeline through OnkosXcel Therapeutics in immuno‑oncology, progress through research, regulatory review, and commercialization efforts.
BioXcel Therapeutics (NASDAQ: BTAI) has submitted a pre-supplemental New Drug Application (pre-sNDA) meeting package to the FDA for IGALMI®, seeking potential label expansion for outpatient use in treating acute agitation associated with bipolar disorders or schizophrenia.
The company has scheduled a pre-sNDA meeting with the FDA for August 20, 2025, following a previous Type C meeting on March 6, 2024. BioXcel is nearing completion of the SERENITY At-Home Pivotal Phase 3 trial, with top-line results expected this quarter. The development addresses a significant unmet need, as approximately 23 million annual episodes of agitation occur in the at-home setting in the U.S., with no current FDA-approved therapies available.
BioXcel Therapeutics (Nasdaq: BTAI) received a second positive recommendation from the Data Safety Monitoring Board (DSMB) to continue its SERENITY At-Home pivotal Phase 3 safety trial of BXCL501 without modifications. The trial evaluates the treatment of agitation associated with bipolar disorders or schizophrenia in at-home settings.
The DSMB's recommendation followed a review of unblinded safety data from 178 patients as of May 28, 2025. The trial, which is now fully enrolled with 200 patients, is testing a 120 mcg dose of BXCL501 in a double-blind, placebo-controlled study design. The company expects to release topline data in Q3 2025.
This trial aims to support a potential supplemental New Drug Application (sNDA) to expand the IGALMI® label for at-home use, addressing an unmet medical need as there are currently no FDA-approved therapies for bipolar and schizophrenia-related agitation in the at-home setting.
BioXcel Therapeutics (NASDAQ: BTAI) received a positive recommendation from the Data Safety Monitoring Board (DSMB) to continue its SERENITY At-Home pivotal Phase 3 safety trial of BXCL501 without modifications. The trial evaluates the safety of a 120 mcg dose for acute treatment of agitation in bipolar disorders or schizophrenia patients in at-home settings.
The DSMB's recommendation followed a review of unblinded safety data from the first 115 patients. The trial is fully enrolled with over 205 patients dosed, and more than 150 patients have received multiple doses during the 12-week trial period. Topline data is expected in Q3 2025. The results aim to support a potential sNDA submission for IGALMI® label expansion in the at-home setting, addressing an unmet medical need as there are currently no FDA-approved therapies for bipolar or schizophrenia-related agitation in this environment.
BioXcel Therapeutics (BTAI) reported its Q4 and full-year 2024 financial results, highlighting significant progress in its SERENITY At-Home Phase 3 trial, which has reached 63% enrollment with 127 patients. The study evaluates BXCL501 for treating agitation in bipolar disorders or schizophrenia patients at home, with topline data expected in H2 2025.
Financial highlights include:
- Q4 2024 IGALMI® revenue of $366,000 (vs $376,000 in Q4 2023)
- Full-year 2024 revenue of $2.3M (vs $1.4M in 2023)
- Q4 net loss of $10.9M (improved from $22.3M in Q4 2023)
- 2024 full-year net loss of $59.6M (vs $179.1M in 2023)
The company secured $14M in equity financing, strengthening its cash position to approximately $35M as of March 4, 2025. Operating expenses decreased significantly, with R&D expenses at $30.4M for 2024 (vs $84.3M in 2023) and SG&A expenses at $34.5M (vs $83.4M in 2023).
BioXcel Therapeutics (BTAI) has strengthened its financial position with approximately $35 million in cash following a successful $14 million equity financing closed on March 4, 2025. The funds will support the advancement of their pivotal Phase 3 SERENITY At-Home trial, evaluating BXCL501's safety for at-home treatment of agitation in patients with bipolar disorders or schizophrenia.
BXCL501 is the company's investigational orally dissolving film formulation of dexmedetomidine. The trial's topline data, expected in the second half of 2025, aims to support a potential supplemental New Drug Application (sNDA) to expand IGALMI's label for at-home use, potentially providing an acute treatment option for millions of additional patients.
BioXcel Therapeutics (BTAI) has achieved 33% enrollment in its SERENITY At-Home pivotal Phase 3 safety trial, with 67 patients enrolled across 23 clinical sites. The trial evaluates BXCL501, an orally dissolving dexmedetomidine film, for treating acute agitation in bipolar disorders or schizophrenia patients at home.
The study focuses on the lowest approved dose of IGALMI® (120mcg) and aims to support a supplemental new drug application (sNDA) for label expansion in the home setting. Topline data is expected in the second half of 2025. Currently, there are no FDA-approved therapies for acute agitation treatment at home, despite an estimated 23 million annual episodes associated with bipolar disorders or schizophrenia in the U.S.
BioXcel Therapeutics (BTAI) has successfully closed its previously announced registered direct offering, raising $14 million in gross proceeds. The offering included 4,000,000 shares of common stock (or equivalents) and accompanying warrants at a combined price of $3.50 per share.
The accompanying warrants allow purchase of up to 4,000,000 additional shares at an exercise price of $4.20 per share, exercisable immediately and expiring in five years. The purchaser has a two-week option to acquire an additional 4,000,000 shares and warrants at the same terms. Rodman & Renshaw served as the exclusive placement agent for this offering, which closed on March 4, 2025.
BioXcel Therapeutics (BTAI) has announced a $14 million registered direct offering of 4,000,000 shares of common stock at $3.50 per share, along with accompanying warrants to purchase an additional 4,000,000 shares. The warrants have an exercise price of $4.20 per share and a five-year expiration term.
The offering includes an option for purchasers to buy up to an additional 4,000,000 shares and warrants within two weeks after closing. Rodman & Renshaw is serving as the exclusive placement agent, with the offering expected to close on March 4, 2025. The company plans to use the net proceeds for working capital and general corporate purposes.
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