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NEW HAVEN, Conn. - BioXcel Therapeutics, Inc. (NASDAQ:BTAI), a biopharmaceutical company with a market capitalization of $8.5 million, announced today that it has achieved 33% enrollment for its SERENITY At-Home trial, a pivotal Phase 3 study evaluating the safety of BXCL501. InvestingPro analysis reveals the company is operating with significant debt burden and rapidly burning through cash, highlighting the importance of successful trial outcomes for its financial future. This investigational drug, in the form of an orally dissolving film, is being tested for the at-home treatment of agitation in patients with bipolar disorders or schizophrenia.
The trial aims to enroll 200 patients and has successfully opened 23 clinical trial sites. The Data Safety Monitoring Board (DSMB) is set to assess safety during the study. BioXcel Therapeutics expects to release topline data in the second half of 2025, which may support a supplemental new drug application (sNDA) for label expansion of the FDA-approved IGALMI® (dexmedetomidine) sublingual film. Despite recent challenges reflected in a -94.37% one-year return, the stock has shown signs of recovery with a notable 26.85% gain over the past week. For deeper insights into BTAI’s financial health and growth prospects, investors can access comprehensive analysis through InvestingPro’s detailed research reports.
IGALMI® is currently approved for use under medical supervision for the acute treatment of agitation associated with schizophrenia and bipolar I or II disorders in adults. The SERENITY At-Home trial is significant as there are no FDA-approved therapies for the acute treatment of agitation in the home setting, despite an estimated 23 million annual episodes occurring in the U.S.
The SERENITY At-Home Phase 3 trial is a double-blind, placebo-controlled study. Participants will self-administer 120 mcg of BXCL501 or a placebo when experiencing agitation over a 12-week period. Safety data and adverse events will be collected, and patients or caregivers will complete a modified global impression of severity (mCGI-S) and a clinical global impression of change (mCGI-C) two hours after dosing as exploratory endpoints.
BioXcel Therapeutics is leveraging its expertise in artificial intelligence to develop transformative medicines in neuroscience. BXCL501 has received Breakthrough Therapy designation from the FDA for the acute treatment of agitation associated with dementia and Fast Track designation for agitation related to schizophrenia, bipolar disorders, and dementia. However, the safety and efficacy of BXCL501 for these investigational uses have not been established.
This press release statement serves as the source of the information reported. With revenue of $2.28 million in the last twelve months and a gross profit margin of 11.03%, BTAI’s financial metrics reflect its development-stage status. InvestingPro subscribers can access 12 additional key insights and detailed financial analysis to make more informed investment decisions about this volatile biotech stock.
In other recent news, BioXcel Therapeutics has made several notable announcements. The company has regained compliance with Nasdaq’s minimum bid price requirement, ensuring its continued listing on the Nasdaq Capital Market. Additionally, the U.S. Food and Drug Administration (FDA) has completed an inspection of a site involved in BioXcel’s TRANQUILITY II Phase 3 trial, issuing a "Voluntary Action Indicated" status. This development, along with favorable findings from an independent audit, supports the potential for a supplemental New Drug Application for BXCL501, an investigational treatment for agitation associated with Alzheimer’s dementia and certain psychiatric disorders. Despite these advancements, BofA Securities has maintained its Underperform rating on BioXcel Therapeutics, citing concerns about the company’s financial constraints and the need for further pipeline expansion. Furthermore, BioXcel Therapeutics has enacted a 1-for-16 reverse stock split, aiming to increase the per-share trading price and improve marketability. The company is actively progressing with its SERENITY At-Home pivotal Phase 3 trial, with topline data expected in the second half of 2025. Lastly, the resignation of Vincent J. O’Neill, M.D., Executive Vice President, Chief of Product Development and Medical Officer, has been announced.
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