Shares of BioXcel Therapeutics (NASDAQ:BTAI) jumped 10% after the company announced that its SERENITY At-Home pivotal Phase 3 safety study successfully achieved its primary endpoint. The results support a planned supplemental New Drug Application (sNDA) to expand the labeling of its IGALMI treatment.
The trial tested BXCL501, BioXcel’s proprietary sublingual film of dexmedetomidine, for at-home management of agitation episodes in patients with bipolar disorder or schizophrenia. BioXcel intends to submit the sNDA in the first quarter of 2026, aiming to allow use of IGALMI in outpatient settings without direct supervision by healthcare professionals.
The 120 mcg dose of BXCL501 was well tolerated with repeated dosing over the 12-week trial. Importantly, no patients discontinued treatment due to tolerability issues, and the adverse event profile matched both the current IGALMI label and prior institutional clinical trials.
“The SERENITY At-Home results are transformative in our journey toward outpatient use of BXCL501 for the acute treatment of agitation associated with bipolar disorders or schizophrenia,” said Vimal Mehta, CEO of BioXcel Therapeutics. “The unmet medical need in the at-home setting is significant with no FDA approved treatments.”
The study included 246 patients, who collectively experienced 2,628 agitation episodes, of which 2,437 episodes were treated across 208 patients. Preliminary exploratory data indicated that BXCL501 consistently alleviated agitation symptoms, with a higher proportion of patients achieving complete symptom resolution compared to placebo.
BioXcel now believes the potential market is much larger than previously estimated. The company suggests that patients in the U.S. experience approximately 57–77 million at-home agitation episodes annually, versus earlier estimates of 23 million.
Currently, IGALMI is FDA-approved for acute agitation linked to bipolar I or II disorder or schizophrenia, but only in medically supervised environments.
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