BioXcel Therapeutics Seeks FDA Approval for At-Home Treatment Expansion

BioXcel Therapeutics has taken a pivotal step toward broadening the use of its key therapeutic product. The company recently submitted a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration. This filing aims to secure approval for the at-home administration of IGALMI® for acute agitation associated with bipolar disorder or schizophrenia. This strategic move could position the company to address a significant unmet need within a multi-billion dollar market segment.

The management team is actively preparing for a potential commercial launch, reflecting confidence in the application's prospects. In a move underscoring this preparation, BioXcel expanded its executive leadership in mid-January to bolster its commercial strategy. The company identifies a substantial market opportunity, estimating the addressable annual episode volume in the United States to be between 57 million and 77 million. Currently, no FDA-approved acute treatment options exist specifically for at-home use in this clinical setting. If the regulatory review is successful, IGALMI® could become available as the first at-home treatment option during 2026.

Investors are awaiting further financial details, which will be disclosed on March 5th when BioXcel reports its fourth-quarter and full-year 2025 results. This update is expected to provide crucial insights into the company's liquidity and its financing strategy for the planned product launch.

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Phase 3 Trial Data Underpins Regulatory Submission

The decision to file the sNDA is supported by safety and tolerability data from the Phase 3 "SERENITY At-Home" clinical study. This trial involved 246 patients and demonstrated that a 120 microgram dose was consistently well-tolerated over a 12-week treatment period.

A critical finding for the proposed at-home use was that no patients discontinued treatment due to tolerability issues. The side effects observed were consistent with the known safety profile of IGALMI® established in earlier inpatient clinical studies. Throughout the course of the investigation, researchers documented and treated more than 2,400 agitation episodes.

Key Recent Developments:
* January 20: Submission of the sNDA for at-home use to the FDA.
* January 12: Expansion of the management team in preparation for commercialization.
* March 5: Scheduled announcement of fourth-quarter and full-year 2025 financial results.