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

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Go back to 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

BioXcel Therapeutics Announces Completion of Pre-NDA Meeting with FDA for BXCL501 for the Acute Treatment of Agitation in Patients with Schizophrenia and Bipolar Disorders

November 11, 2020 7:00 AM EST

Initiated rolling submission of New Drug Application (NDA) with U.S. Food and Drug Administration (FDA)

On track to submit complete NDA in Q1 2021

NEW HAVEN, Conn., Nov. 11, 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 that it has completed its pre-NDA meeting with the FDA for BXCL501 for the acute treatment of agitation in patients with schizophrenia and... More