Bioxcel Therapeutics: Mizuho maintains Neutral, PT raised to $4 from $2

Bioxcel Therapeutics: Mizuho maintains Neutral, PT raised to $4 from $2

Mizuho Financial Group has upgraded its price target for BioXcel Therapeutics (BTAI) to $4 from $2, while maintaining a neutral rating on the biopharmaceutical company. The upgrade comes amid positive topline exploratory efficacy data from BioXcel's SERENITY At-Home Pivotal Phase 3 safety trial for the treatment of agitation associated with bipolar disorders or schizophrenia.

The trial, which evaluated the safety and efficacy of BioXcel's proprietary sublingual film formulation of dexmedetomidine, IGALMI®, demonstrated significant reductions in agitation symptoms compared to placebo. The drug showed consistent benefits with repeat dosing, with complete resolution of agitation symptoms significantly higher with BXCL501 across all severity levels. The trial results further support the potential of BXCL501 for use in the outpatient setting, where there is a substantial unmet need with no FDA-approved options currently available.

BioXcel plans to submit a sNDA in Q1 2026 for expanded usage of IGALMI® in the outpatient setting. The company believes the total addressable market for agitation episodes is significantly higher than previously estimated, with market research indicating that episodes may occur 3-4 times a month on average, with the majority being moderate or severe.

The positive trial results and the upgrade in price target by Mizuho reflect the growing optimism among investors about BioXcel's potential to redefine the treatment paradigm for patients with agitation in the outpatient setting.