BioXcel reports positive Phase 3 SERENITY At-Home data for BXCL501; agitation resolution significantly higher vs placebo

BioXcel Therapeutics, Inc.

SERENITY At-Home trial: 246 patients randomized; BXCL501 showed significant mean reduction in mCGI-S score vs placebo at 2 hours (p<.05).
Complete resolution of agitation in 50% of BXCL501 arm vs 33% placebo overall (p<.0001); severe episodes resolved 61% vs 18% (p<.0001).
Efficacy maintained across repeated dosing and over 12-week duration; mean reduction of 1.2-1.4 in mCGI-S score.
Company revises addressable market estimate to 57-77M agitation episodes annually (from prior 23M) based on trial and survey data.
BXCL501 (IGALMI) is already FDA-approved for medically supervised settings; data supports potential label expansion for at-home use.

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