Business
BioXcel Therapeutics Reports Third Quarter 2020 Financial Results and Provides Business Update
Complete NDA submission for BXCL501 for the acute treatment of agitation in patients with schizophrenia and bipolar disorders on track for Q1 2021 TRANQUILITY
About this update from Bioxcel Therapeutics, Inc.
[{"type":"text","content":"Complete NDA submission for BXCL501 for the acute treatment of agitation in patients with schizophrenia and bipolar disorders on track for Q1 2021\n TRANQUILITY and RELEASE studies are on track; Preparing to initiate a Phase 2 trial with BXCL501 in patients with agitation associated with delirium Encouraging data from the two ongoing combination trials of BXCL701 and KEYTRUDA® was presented at the Society for Immunotherapy of Cancer’s 35th Anniversary Annual Meeting (“SITC”) Strong cash position of $233 million to fund key milestones well into 2022 Company to host conference call today at 8:30 a.m. ET NEW HAVEN, Conn., Nov. 12, 2020 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (“BTI” or the “Company”) (Nasdaq: BTAI), a clinical-stage biopharmaceutical company utilizing artificial intelligence to identify improved therapies in neuroscience and immuno-oncology, today announced its quarterly results for the third quarter ended September 30, 2020 and provided an update on key strategic and operational initiatives. “Building on the successful data readout from the Phase 3 SERENITY trials earlier this year, we have continued to make substantial progress with BXCL501’s development as a treatment for agitation across neuropsychiatric conditions,” stated Vimal Mehta, Chief Executive Officer of BTI. “Recently, we completed our pre-NDA meeting with the FDA and have initiated rolling submission of the NDA. This is a key milestone for our neuroscience franchise, laying a strong foundation for multiple follow-on indications and a catalyst for the ongoing build of our commercial infrastructure. While the TRANQUILITY and RELEASE trials advance, we are preparing to initiate a Phase 2 trial for agitation associated with delirium. Together, we believe that these trials, along with our strong cash position, will help to support our long-term strategy of establishing BXCL501 as an innovative treatment for agitation regardless of the patient’s underlying diagnosis.” Dr. Mehta continued, “We are also making excellent strides advancing our immuno-oncology program, with two combination therapy trials progressing well. Earlier this week, we presented encouraging preliminary efficacy and safety data at SITC from both the Phase 1b/2 trial of BXCL701 and KEYTRUDA® for the treatment of advanced prostate cancer and the MD Anderson-led Phase 2 basket trial i...