SpringWorks: FDA Extends PDUFA Date For Nirogacestat NDA

(RTTNews) - SpringWorks Therapeutics, Inc. (SWTX) announced the FDA has updated the PDUFA action date for the NDA for nirogacestat for the treatment of adults with desmoid tumors. The prior August 27, 2023 PDUFA date has been extended by three months. The FDA notified the company that it required more time to review additional analyses of previously submitted data that had been provided by SpringWorks in response to the FDA's information requests. The NDA was granted Priority Review upon its acceptance by the FDA in February 2023.

"We are confident that the comprehensive data from our Phase 3 DeFi trial demonstrate the transformative benefits that nirogacestat can bring to people with desmoid tumors, who currently do not have an approved therapy," said Saqib Islam, CEO of SpringWorks.

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