BioXcel Completes Key Trial For At-Home Agitation Drug; Stock Up In Pre-market

(RTTNews) - BioXcel Therapeutics Inc. (BTAI) announced the completion of the final patient visit in its pivotal Phase 3 SERENITY At-Home clinical trial, marking a significant milestone in the development of IGALMI (dexmedetomidine) for outpatient use.

In Friday pre-market trading, BTAI was up $0.47, or 35.88%, at $1.78.

The study, which enrolled over 200 patients across 22 U.S. sites, was designed to evaluate the safety of a 120 mcg dose of BXCL501 for the acute treatment of agitation linked to bipolar disorders or schizophrenia in a home setting. Patient distribution was balanced between the two conditions, and no single site contributed more than 11% of the total enrollment.

The vast majority of participants completed the full 12-week study, during which data from more than 2,200 agitation episodes were collected. The trial's double-blind, placebo-controlled design supports the robustness of the findings, and topline results are expected later this month.

The results will inform a planned supplemental New Drug Application (sNDA) aimed at expanding IGALMI's label to include at-home treatment, potentially offering a much-needed therapeutic option for millions of individuals experiencing agitation outside clinical settings

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