SpringWorks Therapeutics Has Initiated A Rolling Submission Of A New Drug Application To FDA For Mirdametinib In Pediatric And Adult Patients With Neurofibromatosis Type 1-associated Plexiform Neurofibromas; Expected To Complete By Q2 Of 2024
Portfolio Pulse from Benzinga Newsdesk
SpringWorks Therapeutics has begun a rolling submission of a New Drug Application to the FDA for Mirdametinib, aimed at treating Neurofibromatosis Type 1-associated Plexiform Neurofibromas in both pediatric and adult patients. The submission process is expected to be completed by the second quarter of 2024.
March 04, 2024 | 11:37 am
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SpringWorks Therapeutics' initiation of a rolling submission for Mirdametinib to the FDA could significantly impact its stock. This step towards potential approval marks a critical development in the company's pipeline.
The initiation of a rolling submission for a new drug application to the FDA is a positive development for SpringWorks Therapeutics, indicating progress in its drug pipeline. This news is likely to be viewed positively by investors, as it represents a step forward towards potential market approval and commercialization of Mirdametinib. Given the specific target of the drug and the completion timeline, this development could lead to increased investor confidence and potentially a rise in stock price in the short term.
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