BioXcel Therapeutics, Inc. - BTAI STOCK NEWS

BioXcel Therapeutics, Inc. (Nasdaq: BTAI) announced that CEO Vimal Mehta will participate in a fireside chat at the H.C. Wainwright Global Investment Conference on May 24 at 9:00 a.m. ET. The discussion will focus on the company's neuroscience and immuno-oncology programs, along with its AI platform for drug discovery and development. Dr. Mehta will also address the launch plans for IGALMI™ (dexmedetomidine) sublingual film, approved for treating agitation in patients with schizophrenia and bipolar disorders. A live webcast will be available for attendees.

BioXcel Therapeutics has received FDA approval for IGALMI™, a sublingual film for treating agitation in adults with schizophrenia or bipolar disorder. The expected cash runway extends to 2025, supported by a $260 million strategic financing. The company is optimizing its commercial launch efforts with a national salesforce beginning deployment on May 23, 2022. Clinical trials for BXCL501 are ongoing, with top-line results anticipated in Q4 2022.

BioXcel Therapeutics (Nasdaq: BTAI) announced that its CEO, Vimal Mehta, will speak at three investor conferences to showcase the company's neuroscience and immuno-oncology programs. The discussions will also highlight their artificial intelligence platform aimed at enhancing drug discovery. Key events include the BofA Securities 2022 Healthcare Conference on May 12, UBS Global Healthcare Conference on May 23, and H.C. Wainwright Global Investment Conference on May 25. The company’s product, IGALMI™, is FDA-approved for treating agitation in adults with schizophrenia or bipolar disorder.

BioXcel Therapeutics (BTAI) has dosed the first patient in the Phase 3 TRANQUILITY II trial of BXCL501 for treating agitation associated with Alzheimer’s disease. This pivotal study is part of a broader program that includes TRANQUILITY III, aiming to evaluate BXCL501’s safety and efficacy in patients aged 65 and older. The company plans to expand clinical sites and assesses both 40 and 60 mcg dosing regimens. BXCL501, recently FDA-approved for schizophrenia-related agitation, has shown promising results in reducing agitation in preliminary studies.

BioXcel Therapeutics (BTAI) will announce its first quarter 2022 financial results on May 9, 2022, before U.S. market opening. The management team will host a conference call at 8:30 AM ET to discuss the results and provide a business update. The call details, including domestic and international dial-in numbers, are provided. BioXcel leverages AI to develop medicines, with its product IGALMI™ approved for treating agitation in certain psychiatric disorders. For further information, the webcast and related materials will be available on their website.

On April 19, 2022, BioXcel Therapeutics (Nasdaq: BTAI) announced the formation of its subsidiary, OnkosXcel Therapeutics, to advance therapies targeting challenging cancers with high unmet needs. The lead asset, BXCL701, is currently in Phase 2 trials for aggressive prostate cancer and has shown promising data. OnkosXcel aims to optimize the oncology franchise and leverage AI for drug development. BXCL701, designed to activate innate immunity, has received Orphan Drug Designation in four indications, suggesting significant potential in treating both 'cold' and 'hot' tumors.

BioXcel Therapeutics (BTAI) announced strategic financing agreements with Oaktree Capital Management and Qatar Investment Authority, providing up to $260 million to support the U.S. commercial launch of IGALMI™ and clinical development of BXCL501. This financing includes a credit agreement of up to $135 million, revenue interest financing of up to $120 million, and a potential equity investment of up to $5 million. The arrangements are expected to extend the company’s cash runway into 2025 and support a pivotal Phase 3 program for treating agitation in Alzheimer’s patients.

BioXcel Therapeutics has announced the FDA approval of IGALMI (dexmedetomidine), the first orally dissolving sublingual film for treating agitation in adults with schizophrenia or bipolar I/II disorder. The approval is significant as it provides a self-administered option with a rapid onset of action, showing effects as early as 20 minutes. The company aims for a Q2 2022 launch, targeting up to 25 million agitation episodes annually in the U.S. This milestone positions IGALMI as an innovative solution in a field long challenged by conventional treatments.

BioXcel Therapeutics (Nasdaq: BTAI) announced significant progress in its clinical initiatives, nearing FDA approval for BXCL501 by the April 5, 2022 PDUFA date. The company launched pivotal Phase 3 trials for BXCL501 in treating agitation in Alzheimer’s patients and submitted an IND for its use in major depressive disorder. Encouraging Phase 2 data for BXCL701 in prostate cancer patients was presented, enhancing its immuno-oncology portfolio. Despite increased R&D and administrative expenses, cash reserves stand at $233 million. A conference call will discuss Q4 and full year 2021 financial results.