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Investing.com - BioXcel Therapeutics (NASDAQ:BTAI) maintained its Buy rating from H.C. Wainwright, which reiterated its $8.00 price target on the stock. According to InvestingPro data, analyst targets range from $1 to $66, reflecting significant uncertainty around the company’s outlook. The stock has fallen over 90% in the past year, with a current market capitalization of just $11.45 million.
The company announced Monday that it submitted a pre-supplemental New Drug Application (pre-sNDA) meeting package to the FDA for IGALMI, seeking potential label expansion for outpatient use in treating acute agitation associated with bipolar disorders or schizophrenia.
The pre-sNDA meeting is scheduled for August 20, 2025, with the primary goal of aligning with the FDA on the content and format of the planned sNDA submission that BioXcel is currently preparing.
BioXcel also plans to reconfirm the understanding reached during its March 6, 2024 Type C meeting with the FDA, where the agency indicated it views the company’s development plans as reasonable for expanding IGALMI’s label to include at-home use.
The company specifically seeks approval for the 120µg BXCL501 dose for acute treatment of agitation associated with schizophrenia or bipolar disorders in the outpatient setting.
In other recent news, BioXcel Therapeutics has submitted a pre-supplemental New Drug Application meeting package to the FDA, aiming to expand the label for IGALMI to include outpatient use for acute agitation related to bipolar disorders or schizophrenia. The company is set to meet with the FDA in August 2025 to discuss this potential expansion. Additionally, BioXcel announced that the United States Patent and Trademark Office has allowed a new patent application for a specific dosing regimen of IGALMI, which will be eligible for listing in the FDA’s Orange Book once issued. In another development, H.C. Wainwright has maintained a Buy rating for BioXcel, raising its price target to $8.00 following positive trial data for the BXCL501 treatment. The SERENITY At-Home Phase 3 trial for BXCL501 has received a recommendation from an independent Data Safety Monitoring Board to continue without modifications after a safety review. These developments reflect BioXcel’s ongoing efforts to advance its treatments for neuropsychiatric conditions.
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