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Investing.com -- BioXcel Therapeutics, Inc. (NASDAQ:BTAI) stock surged 32% following positive pre-sNDA meeting responses from the U.S. Food and Drug Administration regarding the potential expansion of BXCL501 for at-home use in treating agitation associated with bipolar disorders or schizophrenia.
The biopharmaceutical company announced that based on the FDA’s feedback received on August 14, 2025, it believes its planned supplemental New Drug Application (sNDA) regulatory package will be sufficient to support submission, which remains on track for the first quarter of 2026. The company determined that the meeting originally scheduled for August 20, 2025, is no longer required as the objectives were accomplished through the FDA’s written responses.
"We are pleased with the pre-sNDA meeting feedback we received from the FDA, which confirmed agreement on the content and format for our planned sNDA submission, and reflects a shared commitment to addressing the urgent needs of patients living with bipolar disorder or schizophrenia," said Vimal Mehta, Ph.D., CEO of BioXcel Therapeutics.
IGALMI, the brand name for BXCL501, is currently FDA-approved for acute treatment of agitation associated with bipolar I or II disorder or schizophrenia, but only in medically supervised settings. The company is seeking to expand the label to include at-home use, which would potentially transform the treatment paradigm for these conditions.
The sNDA submission will include data from the pivotal Phase 3 SERENITY At-Home trial, a double-blind, placebo-controlled 12-week study evaluating the safety of a 120 mcg dose of BXCL501 in the at-home setting. BioXcel recently completed the last patient last visit for this trial, with topline data expected this month.
BXCL501 has been granted Fast Track Designation by the FDA, highlighting the unmet need as there are currently no FDA-approved therapies for acute treatment of agitation in the at-home setting.
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