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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May 01, 2026 15:54 ET Central banks dominated the economics news flow this week with almost all major ones announcing their latest policy decisions and many boosted expectations for a rate hike in June. In other news, several countries released the preliminary data for first quarter economic growth. In the U.S., comments by Fed Chair Jerome Powell were also in focus as his term ends this month.