SpringWorks Therapeutics Says FDA Accepted New Drug Application And Granted Priority Review For Mirdametinib To Treat Neurofibromatosis Type 1-Associated Plexiform Neurofibromas
Portfolio Pulse from Benzinga Newsdesk
SpringWorks Therapeutics announced that the FDA has accepted its New Drug Application for Mirdametinib, a treatment for Neurofibromatosis Type 1-Associated Plexiform Neurofibromas, and granted it Priority Review with a PDUFA date set for February 28, 2025.
August 28, 2024 | 10:33 am
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SpringWorks Therapeutics' NDA for Mirdametinib has been accepted by the FDA and granted Priority Review, indicating a potentially faster approval process. The PDUFA date is set for February 28, 2025.
The acceptance of the NDA and the granting of Priority Review by the FDA is a significant milestone for SpringWorks Therapeutics. It suggests a faster review process, which could lead to earlier market entry and potential revenue generation. This is likely to positively impact the stock price in the short term.
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