On Friday, H.C. Wainwright reaffirmed its Buy rating on shares of BioXcel Therapeutics (NASDAQ: BTAI) with a consistent price target of $7.00. This confirmation follows the company's recent announcement regarding the start of a pivotal Phase 3 trial named SERENITY At-Home, which is focused on evaluating the safety of BXCL501 for patients in a home setting.
BXCL501 is an investigational film formulation of dexmedetomidine, intended for the acute treatment of agitation in individuals with bipolar disorders or schizophrenia.
The trial's initiation, announced on Thursday, marks a significant step for BioXcel Therapeutics, as it moves forward with its clinical development program. The study is designed to assess the safety of administering BXCL501 at home, which could offer a new method for managing acute agitation outside of a clinical environment. The trial is expected to last between nine to twelve months, indicating that top-line results could be available in the second half of 2025.
The continuity of the $7.00 price target by H.C. Wainwright signals confidence in the potential of BXCL501 and its commercial prospects. This optimism is underpinned by the progress of the SERENITY At-Home trial and its relevance to the treatment of bipolar disorders and schizophrenia, which affect a significant patient population.
BioXcel Therapeutics' commitment to advancing BXCL501 through the clinical trial process demonstrates the company's dedication to addressing the needs of patients with psychiatric disorders. The ongoing development of this treatment option could potentially introduce a new approach to managing acute agitation linked to these conditions.
The reiteration of the Buy rating and price target by H.C. Wainwright provides a positive outlook for BioXcel Therapeutics as it continues to explore the therapeutic benefits and safety of BXCL501 in the at-home setting. With the trial results anticipated in the latter half of 2025, stakeholders and investors will be watching closely for the outcomes that may shape the future of acute agitation treatment.
In other recent news, BioXcel Therapeutics has embarked on a Phase 3 trial for its agitation treatment, BXCL501, marking a significant milestone in the company's journey. The pharmaceutical company has also reported a Q2 revenue of $1.1 million, primarily from sales of IGALMI, surpassing the projected $0.8 million.
On the analyst front, Canaccord Genuity maintained a Buy rating for BioXcel, while Mizuho Securities revised its 12-month price target from $4.00 to $1.00, maintaining a neutral rating. H.C. Wainwright also adjusted its BioXcel outlook, reducing the price target to $7.00 but sustaining a buy rating.
BioXcel Therapeutics has made several strategic moves recently, including revising its commercial supply agreement with ARx, potentially easing its financial commitments. The company also reported positive IGALMI study results involving patients with bipolar disorder or schizophrenia, with the drug showing good tolerance. Furthermore, the company has doubled the number of authorized shares from 100 million to 200 million.
These recent developments underscore BioXcel Therapeutics' active governance and strategic direction as it advances its late-stage clinical programs for BXCL501 treatment, plans to file a supplemental New Drug Application in 2025, and explores financing options and potential partnerships for future growth.
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