BioXcel Therapeutics' BXCL501 meets primary endpoint in SERENITY At-Home Phase 3 trial for agitation

BioXcel Therapeutics, Inc.

Phase 3 SERENITY At-Home trial met primary safety endpoint; no drug-related SAEs, syncope, or falls in 2,437 episodes treated with 120 mcg BXCL501.
No discontinuations due to tolerability in BXCL501 arm; adverse event profile consistent with approved IGALMI label.
Company plans sNDA submission for label expansion to at-home setting in Q1 2026; market opportunity estimated at 57–77 million annual episodes in US.
Exploratory efficacy data show greater percentage of patients achieved full agitation resolution with BXCL501 vs placebo, with consistent benefit across repeat dosing.

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