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NEW HAVEN, Conn. - BioXcel Therapeutics, Inc. (NASDAQ:BTAI), a biopharmaceutical company leveraging artificial intelligence in drug development, announced that the U.S. Food and Drug Administration (FDA) has closed an inspection of one site involved in its TRANQUILITY II Phase 3 trial under 21 C.F.R.20.64(d)(3). The FDA has issued a Voluntary Action (WA:ACT) Indicated notice for the site, as per the company’s recent statement. According to InvestingPro data, the company has shown strong revenue growth of 83% over the last twelve months, though it operates with significant debt of approximately $105 million.
This development follows the independent audit results released in October 2023, which the company believes further supports the integrity of the data from the TRANQUILITY II trial. The findings are expected to bolster the clinical evidence for a potential supplemental New Drug Application (sNDA) submission. InvestingPro analysis indicates the company’s stock has recently shown positive momentum with a 9.6% return over the past week, despite facing significant challenges in maintaining profitability. InvestingPro subscribers have access to 13 additional key insights about BTAI’s financial health and market position.
The TRANQUILITY II trial is part of BioXcel Therapeutics’ research into BXCL501 (dexmedetomidine), an investigational treatment for agitation associated with Alzheimer’s dementia and certain psychiatric disorders. While BXCL501 is already FDA-approved as IGALMI® for a different indication, its efficacy and safety for these new uses remain under investigation.
The next phase of the research, the TRANQUILITY In-Care Phase 3 trial, has already received FDA protocol feedback. This double-blind, placebo-controlled study will evaluate BXCL501’s efficacy and safety in treating Alzheimer’s dementia-related agitation over a 12-week period in a care setting.
BioXcel Therapeutics’ CEO, Vimal Mehta, Ph.D., expressed confidence in advancing the TRANQUILITY program and the company’s lead neuroscience asset, BXCL501, following the FDA’s recent inspection closure.
The company’s approach to drug development combines existing approved drugs and clinically validated candidates with big data analytics and proprietary machine learning algorithms. BioXcel Therapeutics also has a subsidiary, OnkosXcel Therapeutics, focused on immuno-oncology medicine development.
The information in this article is based on a press release statement from BioXcel Therapeutics.
In other recent news, BioXcel Therapeutics has announced the implementation of a 1-for-16 reverse stock split, which will take effect soon, aiming to regain compliance with Nasdaq’s minimum bid price requirement. The company’s common stock will begin trading on a split-adjusted basis under the same ticker symbol. This move comes after BioXcel Therapeutics regained compliance with Nasdaq’s minimum bid price rule, having sustained the necessary minimum closing bid price over a specified period. Additionally, BioXcel Therapeutics is advancing key clinical trials for its drug BXCL501, with patient enrollment progressing in the SERENITY At-Home Phase 3 trial for treating agitation in bipolar disorder and schizophrenia patients. The company has also outlined plans for the TRANQUILITY In-Care Phase 3 trial for agitation associated with Alzheimer’s dementia.
In financial developments, BioXcel Therapeutics reported third-quarter sales of approximately $214,000, falling short of the $1.2 million forecast by H.C. Wainwright. The firm has faced financial challenges and a slowdown in commercial activities for its product IGALMI. Despite these challenges, H.C. Wainwright maintains a Buy rating on the stock but has lowered the price target to $3 from $5, citing the company’s financial hurdles. BioXcel has also strengthened its leadership team with new Board of Directors appointments and has raised $7 million in equity funding to enhance its operational and financial flexibility.
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