BioXcel Therapeutics, Inc., a biopharmaceutical company, has announced the submission of its phase 3 trial protocol for BXCL501 to the U.S. Food and Drug Administration (FDA) on Thursday. The study, named TRANQUILITY In-Care, is pivotal in evaluating the efficacy and safety of a 60 mcg dose of BXCL501, specifically for agitation associated with Alzheimer’s dementia.
The Connecticut-based company, which specializes in pharmaceutical preparations, has designed the trial to provide critical data on the potential of BXCL501 to address a significant need within the Alzheimer's patient community.
Agitation is a common and distressing symptom of Alzheimer's dementia that can significantly affect the quality of life for patients and their caregivers.
The submission of the protocol to the FDA is a key step towards initiating the trial and advancing the development of BXCL501. BioXcel Therapeutics' commitment to addressing complex neurological disorders is reflected in its ongoing research and development efforts.
BXCL501 is a proprietary, non-invasive, orally dissolving thin film formulation of the adrenergic receptor agonist dexmedetomidine. The medication aims to provide a treatment option that is both effective and safe for one of the most challenging aspects of Alzheimer's care.
The announcement comes as the company continues to make strides in the biopharmaceutical industry, with BXCL501 also being evaluated for other neuropsychiatric disorders. As the company awaits the FDA's response to the submitted protocol, the Alzheimer's community watches with anticipation for a potential new treatment option.
In other recent news, BioXcel Therapeutics has made noteworthy strides in its operations and clinical trials. The company reported Q2 revenue of $1.1 million, primarily from sales of IGALMI, surpassing the projected $0.8 million.
BioXcel Therapeutics has also initiated a pivotal Phase 3 trial named SERENITY At-Home, aimed at evaluating the safety of BXCL501 for patients with bipolar disorders or schizophrenia in a home setting.
In the realm of analyst notes, H.C. Wainwright reaffirmed its Buy rating on BioXcel Therapeutics with a consistent price target of $7.00. Canaccord Genuity also maintained a Buy rating and a $7.00 price target for the company.
However, Mizuho Securities revised its 12-month price target from $4.00 to $1.00, maintaining a neutral rating due to concerns about the company's financial health.
BioXcel Therapeutics has also revised its commercial supply agreement with ARx, potentially easing its financial commitments. The company reported positive IGALMI study results involving patients with bipolar disorder or schizophrenia, with the drug showing good tolerance.
Furthermore, the company has increased the number of authorized shares from 100 million to 200 million, marking a significant step in its corporate strategy.
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