Ram Selvaraju, an analyst from H.C. Wainwright, reiterated the Buy rating on Bioxcel Therapeutics. The associated price target remains the same with $10.00.
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Ram Selvaraju’s rating is based on the promising results from Bioxcel Therapeutics’ SERENITY At-Home pivotal Phase 3 trial, which showed positive exploratory efficacy data for their drug BXCL501. The trial demonstrated that BXCL501, a sublingual film formulation of dexmedetomidine, had continued effects and consistent benefits with repeat dosing, supporting its potential use in outpatient settings. This data will support a supplemental New Drug Application for label expansion, indicating a potential growth opportunity for the company.
Additionally, the trial results showed a significant reduction in agitation symptoms across various severity levels when compared to placebo, with sustained benefits over repeated dosing. The drug’s ability to maintain efficacy over a 12-week period further underscores its potential for longer-term treatment. Given the lack of FDA-approved therapies for acute agitation in at-home settings and the Fast Track Designation previously granted to BXCL501, Selvaraju believes that regulatory approval for label extension could be achieved by the end of 2026, reinforcing the Buy rating.
In another report released on September 5, Canaccord Genuity also reiterated a Buy rating on the stock with a $18.00 price target.