BioXcel stock climbs after positive Phase 3 safety trial results

Investing.com -- BioXcel Therapeutics (NASDAQ:BTAI) stock rose 10% after the company announced its SERENITY At-Home pivotal Phase 3 safety trial met its primary endpoint, supporting a planned supplemental New Drug Application (sNDA) for label expansion of its IGALMI treatment.

The trial evaluated BXCL501, BioXcel’s proprietary sublingual film formulation of dexmedetomidine, for at-home treatment of agitation episodes in patients with bipolar disorders or schizophrenia. The company plans to submit an sNDA in the first quarter of 2026 to expand IGALMI’s usage to outpatient settings without healthcare provider supervision.

The 120 mcg dose of BXCL501 demonstrated consistent tolerability across repeat dosing throughout the 12-week trial. Notably, there were no discontinuations due to tolerability in the BXCL501 arm, and the adverse event profile aligned with the approved IGALMI label and previous clinical trials in institutional settings.

"The SERENITY At-Home results are transformative in our journey toward outpatient use of BXCL501 for the acute treatment of agitation associated with bipolar disorders or schizophrenia," said Vimal Mehta, CEO of BioXcel Therapeutics. "The unmet medical need in the at-home setting is significant with no FDA approved treatments."

The trial involved 246 patients who recorded 2,628 agitation episodes, with 2,437 episodes treated across 208 patients. Preliminary exploratory data showed BXCL501 regularly reduced agitation symptoms throughout the trial, with a greater percentage of patients experiencing full symptom resolution compared to placebo.

BioXcel believes the potential market opportunity is significantly larger than previously reported, suggesting patients experience an estimated 57-77 million agitation episodes in the at-home setting annually in the United States, compared to previous estimates of 23 million episodes.

IGALMI is currently FDA-approved for acute treatment of agitation associated with bipolar I or II disorder or schizophrenia, but only in medically supervised settings.

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