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NEW HAVEN, Conn. - BioXcel Therapeutics, Inc. (NASDAQ:BTAI), announced Monday that it has fortified its financial position following a successful equity financing round, closing with $14 million in gross proceeds on March 4, 2025. This capital increase brings the company’s cash reserves to approximately $35 million, a crucial boost given that InvestingPro data shows the company has been quickly burning through cash with a significant debt burden of $105 million. The funds are earmarked for the ongoing Phase 3 SERENITY At-Home trial, which is evaluating the safety of their investigational drug, BXCL501, for at-home use in treating agitation related to bipolar disorders or schizophrenia.
The SERENITY At-Home trial is a double-blind, placebo-controlled study that involves 200 patients who will self-administer either BXCL501 or a placebo when experiencing agitation episodes. The trial’s safety data will be collected over a 12-week period, with topline results expected in the second half of 2025. These results are intended to support a potential supplemental New Drug Application (sNDA) submission to expand the label for IGALMI® (dexmedetomidine sublingual film), currently approved for use under medical supervision, to include at-home treatment settings. According to InvestingPro analysis, the company’s revenue growth reached 83% in the last twelve months, though profitability remains a challenge with negative EBITDA of $74 million.
Vimal Mehta, Ph.D., CEO of BioXcel Therapeutics, expressed optimism about the trial’s progress and the potential to offer an acute treatment option for agitation to patients in their home environment. The company’s investigational drug, BXCL501, is an orally dissolving film formulation of dexmedetomidine, which is being studied for its safety and efficacy in the home setting.
IGALMI® is already approved for the acute treatment of agitation associated with schizophrenia and bipolar I or II disorders in adults. However, its safety and effectiveness have not been evaluated beyond 24 hours from the first dose, and it is not known if it is safe and effective in children. The drug comes with important safety information, including potential side effects such as decreased blood pressure, heart rhythm changes, sleepiness, and withdrawal reactions.
BioXcel Therapeutics is leveraging artificial intelligence in the development of transformative medicines in neuroscience. The company’s approach involves using big data and proprietary machine learning algorithms to identify new therapeutic indications for existing drugs or clinically validated product candidates. For investors interested in deep-dive analysis of AI-driven healthcare companies, InvestingPro offers comprehensive research reports covering over 1,400 US stocks, including detailed financial health scores and expert insights on companies like BioXcel Therapeutics.
This news article is based on a press release statement from BioXcel Therapeutics.
In other recent news, BioXcel Therapeutics has made significant strides in its clinical trials and regulatory compliance. The company announced that it has achieved 33% enrollment in its SERENITY At-Home Phase 3 trial, which is focused on evaluating the safety of BXCL501 for at-home treatment of agitation in patients with bipolar disorders or schizophrenia. This trial involves 23 clinical sites and aims to enroll 200 patients, with topline data expected in the second half of 2025.
Additionally, the FDA has concluded its inspection of a site involved in BioXcel’s TRANQUILITY II Phase 3 trial, issuing a "Voluntary Action Indicated" status, which suggests no immediate regulatory actions are necessary. This development is supported by favorable findings from an independent audit conducted in October 2023. The TRANQUILITY II trial is part of the company’s efforts to explore new uses for BXCL501, an investigational treatment for agitation associated with Alzheimer’s dementia and psychiatric disorders.
BioXcel Therapeutics has also regained compliance with Nasdaq’s minimum bid price requirement, ensuring its continued listing on the Nasdaq Capital Market. Despite these advancements, BofA Securities has maintained its Underperform rating on the company’s stock, citing concerns about BioXcel’s ability to expand its pipeline amid financial constraints. The firm has kept its price target at $4.00, underscoring the challenges the company faces in maximizing the value of its offerings.
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