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NEW HAVEN - BioXcel Therapeutics, Inc. (NASDAQ:BTAI), whose stock has surged over 107% in the past week according to InvestingPro data, announced Wednesday the publication of a study in Frontiers in Pharmacology demonstrating that dexmedetomidine, the active ingredient in its FDA-approved drug IGALMI, significantly reduces stress-induced behaviors in preclinical models.
The research suggests potential applications for BXCL501 beyond its current approved use for acute agitation in bipolar disorder and schizophrenia. According to the study, dexmedetomidine exhibited higher potency than other alpha2-adrenergic receptor agonists and mitigated responses to both acute and repeated stress. While the company’s gross profit margins remain negative, InvestingPro analysis reveals 11 additional key insights about BTAI’s financial health and market position.
Key findings showed the compound maintained effectiveness with repeated dosing, produced no withdrawal effects after discontinuation, and did not impair motor function or cognition at effective doses. The research also noted favorable effects on sleep patterns.
"Dexmedetomidine reduces agitation through potent, selective agonist action at central alpha-2 adrenergic receptors," said Frank Yocca, Chief Scientific Officer at BioXcel Therapeutics, in the press release.
Several academic institutions are currently investigating daily dosing of BXCL501 for stress-related conditions including opioid withdrawal, acute stress disorder, and alcohol use disorder in patients with PTSD.
BXCL501 has previously received Breakthrough Therapy designation from the FDA for acute treatment of agitation associated with dementia and Fast Track designation for acute treatment of agitation associated with schizophrenia, bipolar disorders, and dementia.
The company is currently conducting the SERENITY At-Home Phase 3 trial evaluating the safety of BXCL501 for at-home treatment of agitation in patients with bipolar disorders or schizophrenia.
This article is based on a press release statement from BioXcel Therapeutics. With the company’s next earnings report expected on August 6, 2025, and analysts setting price targets ranging from $1 to $66, investors can access comprehensive analysis and Fair Value estimates through InvestingPro’s detailed research reports, available for over 1,400 US stocks.
In other recent news, BioXcel Therapeutics announced the completion of the last patient visit in its pivotal Phase 3 SERENITY At-Home clinical trial for IGALMI (dexmedetomidine). The trial evaluates the treatment of agitation associated with bipolar disorders or schizophrenia in at-home settings. Topline data from this trial is anticipated to be released this month. H.C. Wainwright has reiterated its Buy rating on BioXcel Therapeutics stock, maintaining an $8.00 price target, following the company’s announcement of this clinical milestone. In contrast, Mizuho has significantly reduced its price target for BioXcel Therapeutics to $2.00 from $16.00, while maintaining a Neutral rating. This adjustment reflects Mizuho’s updated financial model, incorporating recent financings and forecasts for the company’s IGALMI product. Additionally, BioXcel Therapeutics submitted a pre-supplemental New Drug Application meeting package to the FDA, seeking potential label expansion for IGALMI’s outpatient use. These developments highlight the company’s ongoing efforts to advance its product pipeline and address market challenges.
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