BioXcel Therapeutics stock price target raised to $10 from $8 at H.C. Wainwright

Investing.com - H.C. Wainwright raised its price target on BioXcel Therapeutics (NASDAQ:BTAI) to $10.00 from $8.00 on Monday, while maintaining a Buy rating ahead of upcoming clinical trial data. According to InvestingPro data, the stock has shown strong momentum with a 141% return over the past six months, despite currently trading above its Fair Value.

The firm noted that BioXcel previously announced completion of the last patient last visit in its pivotal Phase 3 SERENITY At-Home clinical trial, with top-line data expected to be released this month, potentially by the end of next week.

The SERENITY At-Home study is a double-blind, placebo-controlled trial evaluating the safety of a 120µg dose of BXCL501 for acute treatment of agitation associated with bipolar disorders or schizophrenia in the at-home setting, enrolling more than 200 patients across 22 sites nationwide.

BioXcel has already submitted a pre-supplemental New Drug Application meeting package to the FDA for IGALMI and is scheduled to meet with the FDA on August 20, 2025, in support of a potential label expansion for outpatient use.

H.C. Wainwright views the upcoming SERENITY readout as "low-risk" since the primary outcome is safety-based, and believes BioXcel could file for the expanded label by the end of this year with potential approval in the second half of 2026.

In other recent news, BioXcel Therapeutics, Inc. has received positive feedback from the U.S. Food and Drug Administration (FDA) regarding its planned supplemental New Drug Application (sNDA) for the at-home use of IGALMI. The company announced that the FDA’s responses, which were received in mid-August, suggest that their regulatory package will be sufficient for submission in the first quarter of 2026, eliminating the need for a previously scheduled meeting. In addition, BioXcel has published a study in Frontiers in Pharmacology highlighting that dexmedetomidine, the active ingredient in IGALMI, reduces stress-induced behaviors in preclinical models, indicating potential applications beyond its current uses.

Furthermore, H.C. Wainwright has reiterated its Buy rating on BioXcel Therapeutics, maintaining a price target of $8.00 following the completion of a pivotal Phase 3 clinical trial milestone. This trial, known as SERENITY At-Home, marks the last patient visit, according to the firm. These developments reflect BioXcel’s ongoing efforts to expand the use of its products and strengthen its pipeline.

This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.