SpringWorks Therapeutics: FDA Extends Review of Nirogacestat
05 June 2023 - 9:48PM
Dow Jones News
By Colin Kellaher
SpringWorks Therapeutics on Monday said the U.S. Food and Drug
Administration has extended its review of the company's application
seeking approval of nirogacestat for adults with desmoid tumors by
three months.
SpringWorks said the FDA needs more time to review additional
analyses of previously submitted data that the Stamford, Conn.,
clinical-stage biopharmaceutical company provided at the agency's
request.
SpringWorks said the FDA has extended its target action date on
the application to Nov. 27 from Aug. 27, adding that the agency
hasn't requested any additional data or studies.
Write to Colin Kellaher at colin.kellaher@wsj.com
(END) Dow Jones Newswires
June 05, 2023 07:33 ET (11:33 GMT)
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