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BTAI: PDUFA Date for BXCL501 Extended to April 5, 2022


By David Bautz, PhD



Business Update

FDA Review of BXCL501 Extended to April 5, 2022

On December 1, 2021, BioXcel Therapeutics, Inc. (NASDAQ:BTAI) announced that the FDA has extended the previously announced PDUFA date of January 5, 2022 for its review of the New Drug Application (NDA) for BXCL501 for the treatment of agitation associated with schizophrenia and bipolar disorder to April 5, 2022. The agency had requested information pertaining to analyses of clinical data and recently informed the company that it would require additional time for review. There was no additional data requested by the FDA.

While the PDUFA delay is discouraging, a look back at the last few years shows that a PDUFA delay usually does not lead to a drug being rejected. As the following table shows, of the 18 PDUFA delays identified from 2015-2021, 16 led to eventual approval of the drug (EvaluatePharma; Note: avacopan was approved Oct. 7, 2021).


A PDUFA delay is never welcome, however as the chart above shows it is usually not a reason for investors to panic. We are unsure of the exact nature of the request from the FDA, however it is encouraging that the agency did not ask for additional data. We continue to remain positive on the prospects for BXCL501 in agitation and our current valuation remains at $110.

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