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Investing.com - H.C. Wainwright has reiterated its Buy rating and $8.00 price target on BioXcel Therapeutics (NASDAQ:BTAI) stock following the company’s announcement of a clinical trial milestone. The stock, currently trading at $1.78, has seen a significant decline of 19.4% in the past week, with analyst price targets ranging from $1 to $66. According to InvestingPro analysis, the company’s overall financial health score is currently rated as Weak.
BioXcel Therapeutics announced late last week the completion of the last patient last visit in its pivotal Phase 3 SERENITY At-Home clinical trial, according to H.C. Wainwright.
Top-line data from the study is expected to be released this month, likely during the second half of August, and will support a planned supplemental New Drug Application to potentially expand the label of IGALMI (dexmedetomidine).
The potential label expansion would allow IGALMI to be used in at-home (outpatient) settings, beyond its current approved uses.
H.C. Wainwright believes BioXcel could file for the expanded label by the end of this year, with a possible label extension approval in the second half of 2026.
In other recent news, BioXcel Therapeutics has completed its pivotal Phase 3 SERENITY At-Home clinical trial for IGALMI (dexmedetomidine), marking a significant milestone for the company. The trial evaluated the treatment of agitation associated with bipolar disorders or schizophrenia in at-home settings, with topline data expected to be released this month. In parallel, BioXcel has submitted a pre-supplemental New Drug Application (pre-sNDA) to the FDA, seeking to expand IGALMI’s label for outpatient use, with a meeting scheduled for August 2025 to discuss further development plans.
Analyst firms have also weighed in on BioXcel’s recent activities. H.C. Wainwright has reiterated its Buy rating with an $8 price target, reflecting optimism about the company’s clinical advancements. Conversely, Mizuho (NYSE:MFG) has adjusted its outlook, slashing the price target from $16 to $2 while maintaining a Neutral rating, citing revised financial models and recent financings. These developments indicate differing perspectives on BioXcel’s future prospects within the investment community.
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