Bioxcel Therapeutics Receives Buy Rating from Canaccord Genuity with $18 Price Target

Bioxcel Therapeutics (BTAI) has received a Buy rating from Canaccord Genuity with a price target of $18.00. The company's shares closed last Friday at $5.48. BTAI has an analyst consensus of Strong Buy with a price target consensus of $10.00, an 82.48% upside from current levels. BTAI's market cap is $79.77M and has a P/E ratio of -0.43.

BioXcel Therapeutics Inc. (BTAI) shares surged by 14.59% on Monday, closing at $5.48, after the company announced positive meeting comments from the U.S. Food and Drug Administration (FDA). The feedback received during a pre-supplemental New Drug Application (sNDA) meeting has bolstered BioXcel's confidence in its planned submission for BXCL501, a treatment for agitation associated with bipolar disorders or schizophrenia [3].

The FDA agreed on the content and format of the sNDA submission, which is now on track for submission in the first quarter of 2026. The pre-sNDA meeting, originally scheduled for August 20, 2025, was deemed unnecessary after receiving the preliminary comments from the FDA on August 14, 2025. The feedback will serve as the official record for the meeting [3].

The primary focus of the pre-sNDA meeting was to gain alignment with the FDA regarding the content and format of the sNDA submission for the at-home (outpatient) use of BXCL501. The FDA's approval of the planned submission reflects a shared commitment to addressing the urgent needs of patients suffering from agitation [3].

BXCL501 is an investigational proprietary, orally dissolving film formulation of dexmedetomidine, a selective alpha-2 adrenergic receptor agonist. It is under investigation for the acute treatment of agitation associated with Alzheimer's dementia and bipolar disorders or schizophrenia in the at-home setting. The company recently completed the last patient last visit (LPLV) of its pivotal Phase 3 SERENITY At-Home trial, with topline data expected soon [3].

The positive FDA feedback is a significant milestone for BioXcel Therapeutics, as it brings the company closer to bringing a safe and effective outpatient treatment to patients suffering from agitation. This development has the potential to transform the treatment paradigm for bipolar disorder and schizophrenia [3].

Analysts have also shown optimism for BioXcel. H.C. Wainwright analyst Raghuram Selvaraju raised BioXcel's price target to $10 from $8 and maintained a Buy rating following the company's Q2 2025 financial report. The analyst expressed heightened enthusiasm for BXCL501's prospects and expects BioXcel to file for an expanded label by the end of this year, with potential approval in the second half of 2026 [2].

BioXcel completed its SERENITY At-Home pivotal Phase 3 safety trial for acute treatment of agitation associated with bipolar disorders or schizophrenia. Topline results from the study are expected in August, with the trial enrolling more than 200 patients across 22 sites nationwide [2]. The company is also seeking FDA approval to expand the label for IGALMI to include at-home administration [2].

The company's strong clinical pipeline, patent extensions, and substantial market opportunity have bolstered investor confidence. BioXcel's BXCL501 is targeting the at-home treatment market, which is projected to be three to four times larger than institutional settings. The company has approximately $18.6 million in cash reserves to fund ongoing trials and sNDA preparation [2].

BioXcel Therapeutics, Inc. is a biopharmaceutical company that engages in the development of artificial intelligence solutions in neuroscience and immuno-oncology. It was founded by Vimal D. Mehta on March 29, 2017 and is headquartered in New Haven, CT [1].

References:
[1] https://www.cnn.com/markets/stocks/BTAI
[2] https://www.ainvest.com/news/bioxcel-therapeutics-price-target-raised-10-wainwright-analyst-2508/
[3] https://www.ainvest.com/news/bioxcel-therapeutics-stock-surges-fda-positive-meeting-comments-2508/