BioXcel Therapeutics
🇺🇸United States
- Country
- 🇺🇸United States
- Ownership
- Public
- Established
- 2017-01-01
- Employees
- 74
- Market Cap
- $26.8M
- Introduction
BioXcel Therapeutics, Inc. is a biopharmaceutical company, which engages in the development of artificial intelligence solutions in neuroscience and immuno-oncology. It also focuses on utilizing technology and research to develop therapeutics solutions. The company was founded by Vimal D. Mehta on March 29, 2017 and is headquartered in New Haven, CT.
MindMed Appoints Matt Wiley as Chief Commercial Officer to Lead MM120 Launch Strategy
• MindMed has appointed Matt Wiley as Chief Commercial Officer to oversee the commercial strategy for MM120 ODT, a potential treatment for generalized anxiety disorder and major depressive disorder.
• Wiley brings over 25 years of experience in specialty product launches, including successful commercialization of neuroscience therapeutics like XYREM®, which achieved blockbuster status under his leadership.
• The appointment comes as MindMed prepares for multiple Phase 3 clinical readouts in 2026, positioning the company to potentially address the needs of over 50 million people suffering from anxiety and depression.
BioXcel Therapeutics Secures $14M Through Direct Stock Offering to Institutional Investors
• BioXcel Therapeutics has entered into a securities purchase agreement with institutional investors, raising $14M through a registered direct offering of common stock and warrants.
• The offering includes 4 million shares of common stock and accompanying warrants at a combined price of $3.50 per share and warrant package.
• The transaction, expected to close on March 4, will provide essential working capital for BioXcel's general corporate operations.
FDA Approves Genentech's TNKase for Acute Ischemic Stroke with Simplified Administration
• The FDA has approved Genentech's TNKase, a clot-dissolving agent, for treating acute ischemic stroke in adults, marking the company's second stroke treatment approval.
• TNKase offers a streamlined five-second intravenous bolus administration, presenting a significant advantage over the current standard treatment Activase's 60-minute infusion protocol.
• The approval is supported by a multi-center non-inferiority study across 22 Canadian stroke centers, demonstrating comparable safety and efficacy to Activase in patients with disabling neurological deficits.
FDA Concludes Inspection of BioXcel's TRANQUILITY II Phase 3 Trial Site with VAI Status
• The FDA has completed its inspection of BioXcel Therapeutics' TRANQUILITY II Phase 3 trial site, designating it as "Voluntary Action Indicated" and releasing the Establishment Inspection Report.
• Independent audit findings from October 2023 combined with the FDA's inspection closure support the data integrity of the trial site, strengthening potential sNDA submission plans.
• BioXcel Therapeutics is proceeding with the TRANQUILITY In-Care Phase 3 trial for BXCL501 following FDA protocol feedback.
BioXcel Therapeutics Advances Phase 3 Trials for BXCL501 in Agitation Treatment
• BioXcel Therapeutics has initiated the SERENITY At-Home Phase 3 trial evaluating BXCL501 for acute agitation in patients with bipolar disorders or schizophrenia, addressing an estimated 23 million annual episodes.
• The company has submitted protocols to FDA for the TRANQUILITY In-Care Phase 3 trial investigating BXCL501 for agitation associated with Alzheimer's dementia, targeting a significant unmet medical need.
• A new Department of Defense grant to UNC will fund a Phase 2a study of BXCL501 for acute stress disorder treatment, expanding the drug's potential applications.
FDA Approves Rexulti as Breakthrough Treatment for Alzheimer's-Related Agitation
• Lundbeck and Otsuka's Rexulti (brexpiprazole) becomes the first FDA-approved medication specifically for treating agitation in Alzheimer's disease patients, affecting approximately 50% of cases.
• Phase 3 clinical trials demonstrated Rexulti's efficacy with a 31% reduction in agitation symptoms compared to placebo, leading to FDA priority review approval.
• The approval could potentially increase Rexulti's annual sales by $500 million to $1 billion, adding to its current $1.4 billion revenue from existing indications in schizophrenia and major depressive disorder.
Axsome's AXS-05 Shows Promise in Alzheimer's Agitation Trials, NDA Submission Planned for 2025
• Axsome Therapeutics' AXS-05 demonstrated a statistically significant delay in agitation relapse in Alzheimer's patients in the ACCORD-2 Phase 3 trial.
• The ADVANCE-2 trial did not meet its primary endpoint, but results numerically favored AXS-05, with a good safety profile across trials.
• Axsome plans to submit an NDA to the FDA in the second half of 2025, supported by data from four Phase 3 trials.
• AXS-05 has Breakthrough Therapy designation, potentially expediting its review for Alzheimer's disease agitation, a condition with limited options.
BioXcel Therapeutics Advances Phase 3 Trials of BXCL501 for Agitation
• BioXcel Therapeutics has randomized the first patient in the SERENITY At-Home trial, evaluating BXCL501 for acute agitation associated with bipolar disorders or schizophrenia.
• The company received FDA feedback on the protocol for the TRANQUILITY In-Care trial, which studies BXCL501 for agitation related to Alzheimer’s dementia.
• These Phase 3 trials address a significant unmet need, with an estimated 140 million annual acute agitation episodes associated with these conditions.
• BXCL501, already approved as IGALMI™ for agitation under supervision, seeks expanded use for at-home treatment and a new indication for Alzheimer's-related agitation.
Three Major Trends Reshaping Precision Medicine: AI, CRISPR, and mRNA Technologies Lead Innovation
• Precision medicine deals reached $97.39 million in 2023, with cell therapies projected to generate over $52 billion by 2029, marking significant growth in personalized treatment approaches.
• AI is revolutionizing precision medicine by accelerating genomic data analysis, drug discovery, and enabling personalized treatment predictions through platforms like Tempus and Foundation Medicine.
• CRISPR gene editing achieved a milestone with FDA approval of Casgevy for sickle cell disease, while mRNA technology expands beyond COVID-19 with Moderna's mRESVIA approval for RSV.
Bioxcel Therapeutics Gains Analyst Confidence with Agitation Treatment Advancements
• H.C. Wainwright reiterated a Buy rating for Bioxcel Therapeutics (BTAI), citing the Phase 3 trial of BXCL501 for agitation in bipolar disorder and schizophrenia.
• The SERENITY At-Home trial's progress and potential for top-line results in H2 2025 could significantly increase the company's value.
• Positive outcomes from the IGALMI post-marketing study, showing no tachyphylaxis, tolerance, or withdrawal, further support the Buy rating.
• FDA's positive review of the SERENITY trial and planned submission of the TRANQUILITY trial for Alzheimer's agitation are viewed as positive steps.
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