BioXcel Therapeutics (BTAI) Misses Q3 EPS by 27c
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BioXcel Therapeutics (BTAI) Announces Completion of Pre-NDA Meeting with FDA for BXCL501 for Acute Treatment of Agitation in Patients with Schizophrenia and Bipolar Disorders
November 11, 2020 7:07 AM ESTBioXcel 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 that it has completed its pre-NDA meeting with the FDA for BXCL501 for the acute treatment of agitation in patients with schizophrenia and bipolar disorders. BXCL501, which received Fast Track designation from the FDA, is the Companys novel, proprietary, orally dissolving, sublingual thin film formulation of dexmedetomidine (Dex). The purpose of the meeting was to discuss the FDAs expectations regarding the content and formatting of the NDA submission... More
