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SpringWorks Therapeutics Submits New-Drug Application to FDA for Mirdametinib
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SpringWorks Therapeutics Submits New-Drug Application to FDA for Mirdametinib
Jul 1, 2024 5:01 AM

07:44 AM EDT, 07/01/2024 (MT Newswires) -- SpringWorks Therapeutics ( SWTX ) said Monday that it has submitted a new-drug application to the US Food and Drug Administration for mirdametinib to treat patients with neurofibromatosis type 1- associated plexiform neurofibromas, a rare genetic disorder.

The submission includes data from a phase 2b trial that evaluated mirdametinib in patients two years of age and older with type 1- associated plexiform neurofibromas causing significant morbidity.

Shares of SpringWorks Therapeutics ( SWTX ) were up more than 5% in recent premarket activity.

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