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Bioxcel Therapeutics (BTAI) surged 58.42% on August 11, 2025, with a trading volume of $230 million, ranking 452nd in market activity. The company filed an 8-K report disclosing a corporate presentation outlining BXCL501’s commercial potential ahead of pivotal Phase 3 trial results. The SERENITY At-Home study, evaluating BXCL501 for at-home treatment of bipolar and schizophrenia-related agitation, remains a key focus, with topline data expected in Q3 2025.
Recent updates include a second positive recommendation from the Data Safety Monitoring Board (DSMB) to continue the Phase 3 trial without modifications, following safety data reviews from 178 patients. The trial, now fully enrolled with 200 participants, aims to support a supplemental New Drug Application (sNDA) to expand IGALMI’s label for outpatient use.
also announced participation in the Canaccord Genuity Growth Conference, where CEO Vimal Mehta will discuss strategic progress.Financially, the company secured $14 million in equity financing, boosting cash reserves to $35 million as of March 2025. This follows a Q1 2025 net loss of $7.3 million, improved from $26.8 million in Q1 2024. The firm faces Nasdaq compliance requirements to maintain its listing, with a deadline of September 16, 2025. Despite challenges, the SERENITY trial’s progress and BXCL501’s potential market expansion remain critical catalysts for investor sentiment.
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