24/7 Market News Snapshot 18 August, 2025 – BioXcel Therapeutics, Inc. Common Stock (NASDAQ:BTAI)

August 18, 2025

DENVER, Colo., 18 August, 2025 (www.247marketnews.com) – (NASDAQ:BTAI) are discussed in this article.
BioXcel Therapeutics, Inc. (BTAI) is experiencing a notable surge in its stock price, currently valued at $7.309, which marks an impressive increase of approximately 33.38% from its previous close of $5.480. This uptick in pre-market trading comes alongside an active volume of 8.89 million shares, reflecting heightened investor enthusiasm and positive market sentiment regarding the company’s prospects.

This excitement is largely driven by BioXcel’s recent developments in the treatment of agitation related to bipolar disorder and schizophrenia. The company has received favorable feedback from the U.S. Food and Drug Administration (FDA) after a pre-submission meeting regarding its intent to submit a supplemental New Drug Application (sNDA) for its product, IGALMI. The forthcoming submission aims to expand IGALMI’s indications to include at-home use, enhancing options for patients in need of effective treatment.

Dr. Vimal Mehta, CEO of BioXcel Therapeutics, emphasized the significance of this FDA interaction, describing it as a pivotal advancement in the company’s dedication to addressing the urgent needs of those suffering from these mental health conditions. The sNDA is expected to be submitted in the first quarter of 2026, incorporating data from the SERENITY At-Home Phase 3 clinical trial, which assesses the safety of BXCL501—a proprietary dexmedetomidine formulation administered by patients themselves during episodes of agitation in their home environments.

Currently approved for use in medically supervised settings, IGALMI is poised to fill a critical gap in at-home treatment options for acute agitation, setting the stage for a potential transformation in mental health care delivery. As BioXcel continues to gather data and prepare for pivotal trials, it remains committed to leveraging innovative strategies to redefine therapeutic approaches in psychiatry.

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