Business
BioXcel Therapeutics Reports First Quarter 2022 Financial Results and Recent Operational Highlights
Received FDA approval of IGALMI™ (dexmedetomidine) sublingual film for acute treatment of agitation associated with schizophrenia or bipolar I or II disorder
About this update from Bioxcel Therapeutics, Inc.
[{"type":"text","content":"Received FDA approval of IGALMI™ (dexmedetomidine) sublingual film for acute treatment of agitation associated with schizophrenia or bipolar I or II disorder in adults Top-line data readout in Q4 2022/early Q1 2023 for TRANQUILITY II Phase 3 trial evaluating BXCL501 in acute treatment of agitation associated with Alzheimer’s disease Extended cash runway into 2025 with $260 million strategic financing for IGALMI commercial launch and clinical and regulatory milestones U.S. national salesforce deployment to commence on May 23, 2022 To host conference call today, May 9, 2022, at 8:30 a.m. ET NEW HAVEN, Conn., May 09, 2022 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (Nasdaq: BTAI), a commercial-stage biopharmaceutical company utilizing artificial intelligence approaches to develop transformative medicines in neuroscience and immuno-oncology, today announced its financial results for the first quarter ended March 31, 2022 and provided an update on key strategic initiatives. “2022 has already been a transformative year during which we have made monumental progress on our journey to become the leading AI-enabled neuroscience company. Our recent achievements across our clinical, business, and commercial priorities, highlighted by our first FDA approval of IGALMI, have positioned us to realize our 2022 goals and beyond,” said Vimal Mehta, Ph.D., CEO of BioXcel Therapeutics. “Building on this momentum, we are excited to launch IGALMI, advance our proven technology, and continue delivering innovative medicines to patients and caregivers.” Company Highlights Neuroscience Franchise IGALMI™ Approval and Commercial Launch IGALMI was approved by the FDA on April 5, 2022 for the acute treatment of agitation associated with schizophrenia or bipolar I or II disorder in adults.1 Within these two patient populations in the U.S., up to 25 million agitation episodes occur each year.2-4 The Company is focused on the following key commercial launch activities to provide access to patients and caregivers: Institutional Sales Force: Seasoned sales specialists were onboarded, undergoing training, and will be deployed for launch. The team has an average of over 21 years of industry experience, 14 years in hospital settings, and 8 product launches. Launch meeting to be held in mid-May in preparation for national salesforce deployment on May 23rd across pr...