BioXcel Therapeutics is anticipating to release topline data from the SERENITY At-Home Phase 3 trial in August, focusing on treating agitation in bipolar disorders or schizophrenia patients. An FDA meeting in August aims to support a potential label expansion for IGALMI®. Non-clinical data published suggests BXCL501’s potential for chronic conditions. The company’s financial results for the second quarter of 2025 have been reported, highlighting the completion of the SERENITY At-Home pivotal Phase 3 safety trial. Topline results are expected soon, with positive market research indicating a larger target addressable market than previously estimated. The trial enrolled over 200 patients across 22 sites, with favorable recommendations from the Data Safety Monitoring Board. The Company’s cash position has been strengthened.
BXCL501 is being explored in late-stage clinical programs, including the SERENITY and TRANQUILITY programs. The SERENITY At-Home Phase 3 trial is assessing the safety of a 120 mcg dose of BXCL501 for treating agitation in bipolar disorders or schizophrenia at home. Meanwhile, the TRANQUILITY In-Care Phase 3 Trial is evaluating a 60 mcg dose of BXCL501 for agitation associated with Alzheimer’s dementia in a care setting.
Published research in Frontiers in Pharmacology shows that BXCL501 can reduce stress-induced behaviors related to psychiatric disorders. The company continues to supply IGALMI® to patients in the institutional setting. In the second quarter of 2025, net revenue from IGALMI® was $120 thousand, with increased costs of goods sold and higher research and development expenses compared to the same period in 2024. The Company reported an operating loss of $15.9 million and a net loss of $19.2 million for the second quarter of 2025.
IGALMI® (dexmedetomidine) sublingual film is prescribed for treating agitation in schizophrenia and bipolar disorder I or II in adults. Safety information includes potential side effects like decreased blood pressure and heart rate, heart rhythm changes, and drowsiness. Patients are advised to report any side effects to their healthcare provider. Full prescribing information can be found at Igalmi.com. BioXcel Therapeutics is working on developing transformative medicines in neuroscience and immuno-oncology, utilizing artificial intelligence in drug re-innovation.
Financial statements for the second quarter of 2025 show a decrease in net revenue from IGALMI® compared to the same period in 2024. Operating expenses include cost of goods sold, research and development, and selling, general, and administrative expenses. The Company reported a net loss per share of $2.45 for the second quarter of 2025. As of June 30, 2025, cash and cash equivalents and restricted cash totaled $18.6 million, with additional proceeds from a sales program and warrants exercise received after the quarter ended.
Read more at GlobeNewswire: BioXcel Therapeutics Reports Second Quarter 2025 Financial