Bitcoin price today: gains to $120k, near record high on U.S. regulatory cheer
BioXcel Therapeutics, Inc., a clinical-stage biopharmaceutical company currently trading at $2.16, has announced several updates including regulatory developments, trial progress, and corporate changes, based on its latest SEC filing. According to InvestingPro analysis, the company faces significant financial challenges with a weak overall health score, though it has shown a notable 9.64% return over the past week.
The U.S. Food and Drug Administration (FDA) has concluded its inspection of one site involved in BioXcel’s TRANQUILITY II Phase 3 trial, which is now closed under specific regulatory provisions. The FDA has issued a "Voluntary Action (WA:ACT) Indicated" status, acknowledging the presence of objectionable conditions or practices without recommending any administrative or regulatory actions at this stage.
In other news, the company’s ongoing SERENITY At-Home pivotal Phase 3 trial, which began patient enrollment in September 2024, is assessing the safety of BXCL501, an investigational, orally dissolving film formulation of dexmedetomidine for the acute treatment of agitation in patients with bipolar disorders or schizophrenia. As of February 28, 2025, 23 clinical trial sites are actively enrolling patients, with topline data expected in the second half of 2025. This data aims to support a supplemental new drug application (sNDA) for IGALMI® (dexmedetomidine) sublingual film.
Furthermore, on February 28, 2025, BioXcel received a notice from The Nasdaq Stock Market LLC indicating that the company has regained compliance with the minimum closing bid price requirement, ensuring its continued listing on the Nasdaq Capital Market.
Lastly, the company disclosed the resignation of Vincent J. O’Neill, M.D., who served as Executive Vice President, Chief of Product Development and Medical (TASE:BLWV) Officer, effective the same day.
The information presented here is based on a press release statement from BioXcel Therapeutics and reflects the company’s current status as reported to the SEC.
In other recent news, BioXcel Therapeutics has made significant strides in its clinical trials and regulatory compliance. The company announced the completion of an FDA site inspection for its TRANQUILITY II Phase 3 trial, receiving a Voluntary Action Indicated notice, which supports the integrity of the trial data for a potential supplemental New Drug Application. Additionally, BioXcel Therapeutics has regained compliance with Nasdaq’s minimum bid price rule, following a period of non-compliance. To further ensure compliance, the company enacted a 1-for-16 reverse stock split, affecting all shareholders uniformly and adjusting the number of shares and stock options accordingly. The reverse stock split was approved by the company’s Board of Directors and shareholders to help maintain its Nasdaq listing. BioXcel is also advancing its SERENITY At-Home Phase 3 trial for BXCL501, targeting agitation in bipolar disorders and schizophrenia. Furthermore, the company has amended its credit agreement and raised $7 million in equity funding to enhance its operational flexibility. New appointments to the Board of Directors bring additional clinical and financial expertise to the company.
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