BioXcel receives FDA alignment for IGALMI at-home use submission

NEW HAVEN - BioXcel Therapeutics, Inc. (NASDAQ:BTAI), trading at $5.48 and showing strong momentum with a 141% surge over the past six months according to InvestingPro data, announced Monday it has received positive pre-sNDA meeting responses from the U.S. Food and Drug Administration regarding its planned supplemental New Drug Application for IGALMI’s use in at-home settings.

The company reported that based on the FDA’s feedback, it believes its planned regulatory package will be sufficient to support the sNDA submission, which remains on track for the first quarter of 2026. The FDA’s written responses, received on August 14, will serve as the official record for the pre-sNDA meeting.

IGALMI (dexmedetomidine) sublingual film is currently approved for the acute treatment of agitation associated with bipolar I or II disorder or schizophrenia, but only in medically supervised settings. The planned label expansion would allow for at-home use, where no FDA-approved therapies currently exist for acute agitation treatment.

"This marks an important milestone in our mission to bring a safe and effective outpatient treatment to patients suffering from agitation," said Vimal Mehta, CEO of BioXcel Therapeutics, according to the press release.

The regulatory package will include data from the pivotal Phase 3 SERENITY At-Home trial, a double-blind, placebo-controlled 12-week study evaluating the safety of a 120 mcg dose of BXCL501 for at-home use. The company recently completed the last patient visit, with topline data expected this month.

BXCL501 has been granted Fast Track Designation by the FDA for the acute treatment of agitation associated with bipolar disorders or schizophrenia.

The acceptance of the sNDA will be subject to the FDA’s review of the complete filing when submitted. For investors seeking deeper insights, InvestingPro offers comprehensive analysis of BTAI’s financial health, including 12 additional ProTips and detailed valuation metrics. The Pro Research Report provides expert analysis on what really matters for this biotech company’s future prospects.

In other recent news, BioXcel Therapeutics has announced the completion of the last patient visit in its pivotal Phase 3 SERENITY At-Home clinical trial for IGALMI (dexmedetomidine). This milestone is significant as it evaluates the treatment of agitation associated with bipolar disorders or schizophrenia in at-home settings, with topline data expected later this month. Additionally, H.C. Wainwright has reiterated its Buy rating on BioXcel Therapeutics stock, maintaining a price target of $8.00 following this clinical trial achievement.

Furthermore, BioXcel Therapeutics has received preliminary comments from the U.S. Food and Drug Administration (FDA) ahead of a pre-supplemental New Drug Application (pre-sNDA) meeting scheduled for August 2025. The company is reviewing the feedback, which focuses on aligning the format and content required for its planned sNDA submission. In another development, a study published in Frontiers in Pharmacology highlighted that dexmedetomidine, the active ingredient in IGALMI, significantly reduces stress-induced behaviors in preclinical models. This research suggests potential applications beyond its current approved use for acute agitation in bipolar disorder and schizophrenia.

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