BioXcel Therapeutics, Inc. - BTAI STOCK NEWS

BioXcel Therapeutics (Nasdaq: BTAI) announced that the U.S. FDA has granted Breakthrough Therapy designation for its investigational drug BXCL501, aimed at treating agitation related to dementia. This designation accelerates development and regulatory review for serious conditions. CEO Vimal Mehta emphasized the urgent need for effective treatments in this area, highlighting that current options lack FDA approval and have safety warnings. Positive data from the Phase 1b/2 TRANQUILITY trial supports BXCL501's potential effectiveness.

BioXcel Therapeutics (BTAI) submitted an NDA to the FDA for BXCL501, targeting acute treatment of schizophrenia and bipolar disorder-related agitation. The TRANQUILITY trial met both primary and secondary endpoints, showing significant agitation reduction. Topline results from ongoing BXCL701 trials in aggressive prostate cancer are expected in mid-2021. The company reported a net loss of $21.1 million in Q4 2020, up from $8.3 million in Q4 2019, attributed to increased R&D and operational costs. Cash reserves stood at $213.1 million as of December 31, 2020, facilitating continued clinical advancement.

BioXcel Therapeutics has announced the successful completion of the rolling submission of its New Drug Application (NDA) for BXCL501 to the FDA. This investigational drug targets agitation associated with schizophrenia and bipolar disorders. The NDA submission is a significant milestone, having progressed from first-in-human trials to NDA submission in over two years. BXCL501 is an orally dissolving film of dexmedetomidine, showing promising clinical results in Phase 3 trials. If approved, it could provide an essential treatment option for patients facing agitation.

BioXcel Therapeutics, Inc. (Nasdaq: BTAI) announced a conference call and webcast scheduled for March 11, 2021, at 8:30 AM ET to discuss its fourth quarter and full year 2020 operating and financial results. The company is focused on developing innovative medicines in neuroscience and immuno-oncology through AI techniques. Key projects include BXCL501, targeting agitation and opioid withdrawal, and BXCL701 for aggressive prostate cancer treatment. Further details are available on the company’s website.

BioXcel Therapeutics (BTAI) provided updates on its BXCL501 dementia program, reporting that the 30 mcg dose achieved statistical significance in the TRANQUILITY Phase 1b/2 study. A 40 mcg dose cohort study has been initiated to further inform the development strategy. The end of Phase 2 meeting with the FDA is scheduled for Q2 2021, with a pivotal Phase 3 program expected in H2 2021. BXCL501 aims to address dementia-related agitation, a condition lacking FDA-approved treatments.

BioXcel Therapeutics (Nasdaq: BTAI) announced the appointment of June Bray to its Board of Directors, bringing over 40 years of global regulatory experience in the healthcare sector. Previously a Senior VP at Allergan, Bray has overseen the approval of 32 New Drug Applications (NDAs) in the U.S. Her expertise is expected to assist BioXcel as it prepares to submit its first NDA for BXCL501 this month, signaling the company's transition to a commercial neuroscience-focused organization. Bray aims to leverage her knowledge to enhance treatment options for patients experiencing agitation.

BioXcel Therapeutics (Nasdaq: BTAI) has initiated the Phase 2 PLACIDITY trial for BXCL501, an investigational treatment targeting delirium-related agitation, with topline results expected in Q1 2022. This multicenter, randomized, double-blind study aims to evaluate the safety and efficacy of BXCL501 in ICU patients, including those with COVID-19, by testing ascending doses. The primary endpoint is a reduction in agitation as measured by the Richmond Agitation Sedation Scale. BXCL501 addresses a significant unmet medical need, as no FDA-approved therapies exist for this condition.

BioXcel Therapeutics (BTAI) has appointed Javier Rodriguez as Senior Vice President, Chief Legal Officer, and Corporate Secretary. This decision aligns with the company's transition towards commercialization, particularly in neuroscience. Rodriguez brings over 20 years of legal experience from leading firms, including Indivior PLC. His expertise in biopharmaceuticals and knowledge of proprietary technologies are expected to enhance BioXcel’s strategic direction as it progresses towards filing for FDA approval of its first candidate, BXCL501, targeting neuropsychiatric disorders.

BioXcel Therapeutics (BTAI) will host a virtual Key Opinion Leader (KOL) event on February 19, 2021, from 11:00 am ET to 2:00 pm ET, focusing on BXCL501, an investigational treatment for neuropsychiatric conditions. Experts in schizophrenia, dementia, and opioid withdrawal will discuss the unmet medical needs and the potential impact of BXCL501, which has received Fast Track Designation from the FDA. The event will be accessible via the Company's website, with an archive available for 30 days post-event.