Street Calls of the Week
Investing.com - H.C. Wainwright raised its price target on BioXcel Therapeutics (NASDAQ:BTAI) to $8.00 from $3.00 on Monday, while maintaining a Buy rating on the stock. The new target represents significant upside from the current price of $1.60, with analyst targets ranging from $1.00 to $48.00. According to InvestingPro data, the stock has shown strong returns over the last month despite falling 91% over the past year.
The firm cited positive developments for BXCL501, a treatment for acute agitation in patients with neuropsychiatric and neurodegenerative conditions. In late May 2025, an independent Data Safety Monitoring Board recommended that the SERENITY At-Home pivotal Phase 3 safety trial continue without modification after reviewing unblinded safety data from the first 115 patients.
The SERENITY At-Home trial is fully enrolled and designed as a double-blind, placebo-controlled study evaluating the safety of a 120µg dose of BXCL501 in 200 patients with bipolar disorders or schizophrenia in the at-home setting. More than 205 patients have been dosed, with over 150 receiving multiple doses during the 12-week trial period.
H.C. Wainwright views the upcoming SERENITY readout as "low-risk" since the primary outcome is safety-based and IGALMI (the commercial name for BXCL501) has already received approval in the institutional setting. The firm believes BioXcel could file for the expanded label by the end of 2025 with potential label extension in the second half of 2026.
The price target adjustment accounts for dilution from BioXcel’s March 2025 equity financing, future cash requirements, and the impact of the February 2025 reverse stock split. With a market capitalization of just $9.69 million and an overall Financial Health Score rated as WEAK by InvestingPro, investors should note that analysts anticipate sales decline in the current year. For deeper insights into BTAI’s valuation and growth prospects, including 10+ additional ProTips and comprehensive financial analysis, check out the full Pro Research Report available on InvestingPro.
In other recent news, BioXcel Therapeutics announced that the independent Data Safety Monitoring Board (DSMB) has recommended the continuation of its Phase 3 trial for BXCL501 without modifications. This trial is investigating the use of BXCL501 for treating agitation in bipolar disorder and schizophrenia patients at home. The company expects to release topline data in the third quarter of 2025, which could support a supplemental New Drug Application for expanding the use of its approved medication, IGALMI®. Additionally, BioXcel Therapeutics has been granted an extension by Nasdaq to comply with the Minimum Value of Listed Securities Rule, with a new deadline set for September 16, 2025. This extension is crucial for maintaining its listing status on the Nasdaq Capital Market. Furthermore, BioXcel has initiated an at-the-market equity program, allowing it to sell up to $8,135,000 of its common stock through Canaccord Genuity LLC. This program offers a flexible financing option to support the company’s operations and growth initiatives. These developments highlight BioXcel’s ongoing efforts to advance its pharmaceutical offerings and maintain its market presence.
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