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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Business News
June 19, 2026 16:46 ET Major central banks continued to dominate the economic news flow this week too, led by the Federal Reserve, as they announced their latest policy decisions. The Federal Reserve policy session was in focus as it was the first to be led by the new chief Kevin Warsh. In Europe, central banks of the U.K. and Switzerland announced their rate decisions. In Asia, the Bank of Japan drew attention for its policy moves, while data out of China threw some light on the state of the economy.