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Investing.com - H.C. Wainwright has reiterated a Buy rating and $8.00 price target on BioXcel Therapeutics (NASDAQ:BTAI), currently trading at $1.93, following positive trial developments for its BXCL501 treatment. According to InvestingPro data, analyst targets for the stock range from $1 to $66, reflecting mixed sentiment amid the company’s recent stock performance decline of 89% over the past year.
The company received a second positive recommendation from an independent Data Safety Monitoring Board (DSMB) to continue its SERENITY At-Home pivotal Phase 3 safety trial without modifications. This recommendation came after a review of unblinded safety data from 178 patients dosed as of May 28, 2025. The development comes as BioXcel faces financial challenges, with InvestingPro analysis showing negative EBITDA of $50.43 million and weak gross profit margins.
The SERENITY At-Home trial is evaluating the safety of BXCL501 for acute treatment of agitation associated with bipolar disorders or schizophrenia in at-home settings. The double-blind, placebo-controlled study has fully enrolled with over 205 patients dosed, examining a 120µg dose of the medication.
Trial enrollment was completed in May 2025, with top-line data expected in the third quarter of 2025. Results will support a potential supplemental New Drug Application for label expansion of IGALMI, the commercial name for BXCL501 in the U.S. market, for at-home use.
H.C. Wainwright considers the SERENITY readout low-risk since the primary outcome is safety-based and IGALMI has already received approval in institutional settings. The firm believes BioXcel could file for the expanded label by the end of 2025 and potentially receive label extension in the second half of 2026. With the next earnings report due on August 6, 2025, investors can access comprehensive analysis and 10+ additional key insights through InvestingPro’s detailed research reports, which provide crucial context for evaluating the company’s growth potential.
In other recent news, BioXcel Therapeutics announced that its SERENITY At-Home Phase 3 trial for the investigational treatment BXCL501 will continue without modifications following a positive recommendation from an independent Data Safety Monitoring Board. This trial, which is fully enrolled with 200 patients, evaluates the safety of BXCL501 for acute agitation in bipolar disorders and schizophrenia in a home setting. The company plans to release topline data in the third quarter of 2025, potentially supporting a supplemental New Drug Application to expand the label of its FDA-approved drug IGALMI. In another development, H.C. Wainwright raised its price target for BioXcel Therapeutics from $3 to $8, maintaining a Buy rating, citing the positive progress of the BXCL501 trial. The firm considers the upcoming trial readout as "low-risk" due to the primary outcome being safety-based. BioXcel has also initiated an at-the-market equity offering program, allowing it to sell up to $8,135,000 of its common stock through Canaccord Genuity LLC. Additionally, BioXcel received an extension from Nasdaq to comply with the Minimum Value of Listed Securities Rule by September 16, 2025, to avoid potential delisting.
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