Bioxcel Therapeutics: HC Wainwright Raises PT to $10, Reiterates Buy

Bioxcel Therapeutics: HC Wainwright Raises PT to $10, Reiterates Buy

BioXcel Therapeutics, Inc. (Nasdaq: BTAI) has received a significant boost from HC Wainwright & Co., which recently raised its price target for the company's stock to $10, reiterating a "Buy" rating. The move comes amidst positive clinical trial results for the company's BXCL501, which is being developed as an at-home treatment for agitation associated with bipolar disorders or schizophrenia.

The SERENITY At-Home Pivotal Phase 3 trial, conducted by BioXcel, met its primary endpoint of demonstrating the safety and tolerability of BXCL501 in an at-home setting. The trial, which involved over 2,600 episodes of agitation, showed no discontinuations due to tolerability in the BXCL501 group, indicating a favorable safety profile. Preliminary results also suggest that repeated dosing continues to provide symptomatic relief. Following positive feedback from the FDA, BioXcel plans to submit a supplemental New Drug Application (sNDA) in Q1 2026 to expand BXCL501's use to outpatient settings [1].

The trial's success underscores the potential to address a significant unmet medical need, as there are currently no FDA-approved therapies for at-home agitation treatment. The company's plans to submit the sNDA in Q1 2026 indicate a delay in securing approval for at-home usage, which may hinder potential market entry and profitability in the interim [1].

The positive clinical trial results and the analyst's upgrade have sparked interest among investors. However, the reliance on preliminary results and ongoing analyses may suggest that the final data may not confirm these positive outcomes, raising uncertainty about the robustness of the findings. The company’s plan to submit a supplemental New Drug Application (sNDA) in Q1 2026 indicates a delay in securing approval for at-home usage, which may hinder potential market entry and profitability in the interim [1].

References:
[1] https://www.quiverquant.com/news/BioXcel+Therapeutics+Reports+Successful+Results+from+SERENITY+At-Home+Trial+for+BXCL501+as+At-Home+Treatment+for+Agitation+in+Bipolar+Disorders+and+Schizophrenia