BioXcel Therapeutics (BTAI) announced the completion of the database lock for its SERENITY At-Home pivotal Phase 3 safety trial for the acute treatment of agitation associated with bipolar disorders or schizophrenia. Topline results from the study are expected in August. “The database lock is a significant step forward, and we are thrilled to have reached this critical milestone in an efficient manner as we look forward to reporting top-line results from the SERENITY At-Home pivotal Phase 3 safety trial soon,” said Vimal Mehta, Ph.D., CEO of BioXcel Therapeutics. “I want to extend our heartfelt gratitude to the clinical team, our patients, principal investigators and their study staff, and all our independent service providers for their dedication and collaborative efforts as we seek to make BXCL501 available to patients, as no FDA-approved therapies are available for the acute treatment of agitation in the at-home setting, which remains a significant need.”
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