Bioxcel Therapeutics Inc Stock Price, News & Analysis

BioXcel Therapeutics (Nasdaq: BTAI) reported Q2 2025 financial results and provided key updates on its clinical programs. The company completed its SERENITY At-Home Phase 3 trial for treating agitation in bipolar disorders and schizophrenia patients, with topline results expected in August. The trial enrolled over 200 patients across 22 sites, collecting data from more than 2,200 agitation episodes.

Financial results showed IGALMI® revenue of $120,000 in Q2 2025, down from $1.1M in Q2 2024. The company reported an operating loss of $15.9M and a net loss of $19.2M. Cash position stood at $18.6M as of June 30, 2025, with additional post-quarter funding of $15.1M through ATM sales and warrant exercises.

BioXcel Therapeutics (NASDAQ: BTAI), an AI-driven biopharmaceutical company focused on neuroscience, has announced its participation in the Canaccord Genuity 45th Annual Growth Conference. CEO Vimal Mehta will engage in a fireside chat on August 12, 2025, at 12 p.m. ET in Boston.

Investors can access the presentation through a webcast on the company's website under the Events & Presentations page, with the replay available for 90 days.

BioXcel Therapeutics (Nasdaq: BTAI) announced the publication of a study in Frontiers in Pharmacology demonstrating significant effects of dexmedetomidine, the active ingredient in BXCL501, in reducing stress-induced behaviors. The research supports potential applications beyond its current FDA approval as IGALMI™ for acute agitation in bipolar and schizophrenia patients.

The study revealed that dexmedetomidine showed superior potency compared to other alpha2-adrenergic receptor agonists, effectively mitigated both acute and chronic stress responses, and demonstrated favorable attributes for daily administration. Notably, the compound showed no negative impacts on motor function or cognition and positively affected sleep patterns.

BioXcel Therapeutics (Nasdaq: BTAI) has completed the last patient visit in its pivotal Phase 3 SERENITY At-Home clinical trial, evaluating IGALMI® (dexmedetomidine) for treating agitation in bipolar disorders or schizophrenia patients at home. The study collected data from over 2,200 agitation episodes across more than 200 patients at 22 sites nationwide.

The double-blind, placebo-controlled trial tested a 120 mcg dose of BXCL501 and aims to support a supplemental New Drug Application (sNDA) to expand IGALMI's label for outpatient use. Topline data is expected this month. If approved, IGALMI would become the first FDA-approved therapy for the estimated 23 million annual episodes of bipolar or schizophrenia-related agitation occurring at home in the U.S.

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) has received an extension from the Nasdaq Hearings Panel to maintain its listing on The Nasdaq Stock Market until September 16, 2025. The company must regain compliance with Listing Rule 5550(b)(2), known as the Market Value of Listed Securities (MVLS) Rule. Following a Panel hearing on May 1, 2025, BioXcel was granted continued listing subject to meeting certain interim conditions. CEO Vimal Mehta highlighted the company's focus on the SERENITY At-Home pivotal Phase 3 safety trial of BXCL501, which could support a supplemental New Drug Application (sNDA) to expand the IGALMI® label. However, there is no guarantee that the company will meet the imposed deadlines or conditions for continued listing compliance.

BioXcel Therapeutics (NASDAQ: BTAI) has announced the completion of enrollment in its SERENITY At-Home Phase 3 safety trial for BXCL501, testing acute treatment of agitation in bipolar disorders or schizophrenia patients. The trial has enrolled 200 patients, with over 165 patients dosed and 115 receiving multiple doses over 12 weeks. Topline data is expected in H2 2025. For Q1 2025, BTAI reported IGALMI® revenue of $168,000, down from $582,000 in Q1 2024. The company's net loss improved to $7.3 million from $26.8 million year-over-year, with R&D expenses decreasing to $4.6 million from $11.4 million. Cash position stands at $31 million as of March 31, 2025, with $12 million used in Q1 operations.