24/7 Market News Snapshot 03 March, 2025 – BioXcel Therapeutics, Inc. Common Stock (NASDAQ:BTAI)

March 3, 2025

DENVER, Colo., 03 March, 2025 (247marketnews.com) – (NASDAQ:BTAI) are discussed in this article.
In a notable trading session, BioXcel Therapeutics, Inc. (BTAI) experienced a considerable surge, with its stock price climbing from an opening of $2.40 to a peak of $4.80, representing a more than 122% increase. This surge follows a previous close at $2.16 and reflects strong investor enthusiasm, as evidenced by a trading volume of 13.03 million shares. The significant market movement has sparked interest in BioXcel’s innovative pharmaceutical developments, signaling a transformative period for the company.

Adding to the positive momentum, BioXcel has successfully concluded an FDA inspection of a site involved in its TRANQUILITY II Phase 3 trial, which was assessed under Title 21 C.F.R. 20.64(d)(3). The inspection resulted in a designation of “Voluntary Action Indicated,” further validated by favorable findings from an independent audit conducted in October 2023. This encourages confidence in the integrity of the clinical data collected from this site as BioXcel prepares for a supplemental New Drug Application (sNDA).

Vimal Mehta, Ph.D., CEO of BioXcel Therapeutics, expressed optimism regarding the closure of the investigation. He stated, “We believe this significant report and the closure of the investigation further affirm the reliability of the clinical data from TRANQUILITY II.” With valuable insights from the FDA regarding the protocol for the ongoing TRANQUILITY In-Care Phase 3 trial, BioXcel is poised to make substantial advancements with its lead neuroscience asset, BXCL501.

BXCL501, a novel sublingual film formulation, is currently undergoing evaluations for its efficacy in treating agitation associated with Alzheimer’s dementia and related mood disorders. Approved as IGALMI® (dexmedetomidine), the asset has also received Breakthrough Therapy and Fast Track designations for its investigational applications. The ongoing TRANQUILITY In-Care trial, aimed at assessing BXCL501’s safety and efficacy in care settings for Alzheimer’s patients, is expected to play a critical role in establishing new care standards in the treatment of agitation. BioXcel remains dedicated to utilizing artificial intelligence and innovative methodologies to advance therapeutic approaches in neuroscience and other domains.

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