Why BioXcel Therapeutics Stock Is Slumping Today

Shares of BioXcel Therapeutics (NASDAQ: BTAI) were down by 11.6% as of 3:08 p.m. ET Wednesday. The biotech's shares are retreating today in response to the Food and Drug Administration's decision to extend the review date under the Prescription Drug User Fee Act (PDUFA) for the New Drug Application of BXCL501 for the acute treatment of agitation associated with schizophrenia and bipolar disorders I and II.

Previously, the agency was slated to make a final decision on BXCL501's New Drug Application (NDA) by Jan. 5, 2022. Following this extension, the agency's new target date is April 5, 2022. The good news is that BioXcel reportedly met with the FDA on Tuesday to discuss the NDA, and the company said that the agency isn't requesting any additional clinical data.  

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