Bioxcel Therapeutics (BTAI) has received a reiterated Buy rating from H.C. Wainwright analyst Ram Selvaraju, driven by the company's progress in developing treatments for agitation associated with neurological and psychiatric disorders. The analyst's confidence is underpinned by advancements in the clinical trials for BXCL501 and positive post-marketing data for IGALMI.
SERENITY At-Home Phase 3 Trial
A key factor in the Buy rating is the ongoing SERENITY At-Home pivotal Phase 3 trial. This trial is evaluating the safety of BXCL501, an orally dissolving film, for the acute treatment of agitation in patients with bipolar disorders or schizophrenia. Patient enrollment has commenced, marking a significant step toward potentially providing an at-home treatment option for these conditions. Top-line results are anticipated in the second half of 2025, which could serve as a value inflection point for Bioxcel Therapeutics.
IGALMI Post-Marketing Study
Further bolstering the positive outlook is the recent successful outcome of a post-marketing requirement study of IGALMI. The study demonstrated no signs of tachyphylaxis, tolerance, or withdrawal, reinforcing the treatment's reliability and safety profile. This is particularly important as it addresses concerns about the long-term effectiveness and potential adverse effects associated with the medication.
Regulatory Progress
The FDA's positive review of the SERENITY trial protocol and the anticipated submission of the TRANQUILITY in-care pivotal Phase 3 trial protocol for Alzheimer's agitation are viewed as positive steps forward. These regulatory milestones indicate the agency's support for Bioxcel's clinical development programs and increase the likelihood of eventual approval.
Analyst Confidence
Selvaraju's analysis also highlights the absence of serious adverse events reported in the clinical trials, contributing to the overall positive assessment of Bioxcel Therapeutics' potential. The analyst has maintained a 12-month price target of $7 per share, reflecting confidence in the company's future performance. Canaccord Genuity also reiterated a Buy rating on the stock with a $7.00 price target in a report released on August 30.
