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SpringWorks Therapeutics (NASDAQ:SWTX) said the US Food and Drug Administration has extended the action date on its new drug application for its therapy nirogacestat for the treatment of desmoid tumors in adults by three months.
The biotech company said the FDA’s original action date was Aug. 27. The agency informed SpringWorks that it was extending the action date because it needed more time review additional analyses submitted to support the application’s approval. The company added that no additional data or studies have been requested by the FDA at this time.
Nirogacestat received priority review status from the FDA in February. It’s also received FDA designations as an orphan drug and breakthrough therapy along with fast track status.
SpringWorks said it plans to submit an application for approval with the European Medicines Agency for the drug in 2024.
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