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NEW HAVEN - BioXcel Therapeutics, Inc. (NASDAQ:BTAI), a small-cap biotech with a market capitalization of $11.57 million, announced Monday it has submitted a pre-supplemental New Drug Application meeting package to the FDA for IGALMI, seeking to expand the drug’s label to include outpatient use for acute agitation associated with bipolar disorders or schizophrenia.
The company has scheduled a meeting with the FDA for August 20, 2025, to discuss the content and format of its planned supplemental New Drug Application. BioXcel aims to reconfirm the understanding reached during a previous Type C meeting with the FDA in March 2024 regarding its development approach.
"We are on track with our clinical development and regulatory submission plan for BXCL501 (IGALMI)," said Vimal Mehta, CEO of BioXcel Therapeutics, according to the press release.
The company is nearing completion of its SERENITY At-Home Phase 3 trial, which evaluates the safety of a 120 mcg dose of BXCL501 for acute treatment of agitation in the at-home setting. BioXcel expects to report top-line results from the study this quarter.
Currently, there are no FDA-approved therapies for the acute treatment of agitation in the at-home setting, despite an estimated 23 million annual episodes of agitation associated with bipolar disorders or schizophrenia occurring at home in the U.S. According to InvestingPro data, while BTAI’s stock has faced significant pressure, down nearly 90% over the past year, the company’s expansion efforts could present opportunities. InvestingPro analysis suggests the stock is currently trading below its Fair Value.
IGALMI is currently approved as a prescription medicine administered under healthcare provider supervision for the acute treatment of agitation associated with schizophrenia and bipolar disorder I or II in adults.
The information in this article is based on a company press release statement. With BTAI’s next earnings report scheduled for August 6, 2025, InvestingPro subscribers can access comprehensive analysis, including 10 additional ProTips and detailed financial metrics, to better evaluate the company’s growth prospects. Get the full picture with InvestingPro’s exclusive Research Report, available for over 1,400 US stocks.
In other recent news, BioXcel Therapeutics announced that the United States Patent and Trademark Office has allowed a new patent application related to its product IGALMI, covering a specific dosing regimen for treating acute agitation associated with schizophrenia or bipolar disorder. The patent, once issued, will be listed in the FDA’s Orange Book and is expected to expire in January 2043. Additionally, the company received a second positive recommendation from an independent Data Safety Monitoring Board (DSMB) to continue its SERENITY At-Home Phase 3 trial without modifications. This trial is focused on the safety of BXCL501, a treatment for acute agitation in bipolar disorders or schizophrenia, and has fully enrolled over 205 patients. H.C. Wainwright has maintained a Buy rating on BioXcel Therapeutics, raising its price target to $8.00 from $3.00, citing positive trial developments. The firm considers the upcoming trial readout low-risk, given the primary focus on safety and IGALMI’s existing approval in institutional settings. BioXcel aims to use the trial results to support a supplemental New Drug Application for label expansion of IGALMI for at-home use by the end of 2025. The company is also leveraging artificial intelligence in its drug development efforts, aiming to transform treatment options in neuroscience and immuno-oncology.
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