SpringWorks Therapeutics Initiates Rolling Submission of New Drug Application to the FDA for Mirdametinib for the Treatment of Children and Adults with NF1-PN [Yahoo! Finance]
SpringWorks Therapeutics, Inc. - common stock (SWTX)
Last springworks therapeutics, inc. - common stock earnings: 3/12 04:30 pm
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Source: Yahoo! Finance
focused on severe rare diseases and cancer, announced today that the Company has initiated a rolling submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for mirdametinib, an investigational MEK inhibitor, in pediatric and adult patients with neurofibromatosis type 1-associated plexiform neurofibromas (NF1-PN). “There is tremendous potential for mirdametinib to address the substantial needs that exist for children and adults with NF1-PN, and the initiation of our rolling NDA submission brings us one step closer toward our goal of providing these patients with a best-in-class therapy that could make a significant impact on their lives,” said Saqib Islam, Chief Executive Officer of SpringWorks. “We are excited to advance the regulatory filing for our second product and look forward to working closely with the FDA on their review of our application.” The NDA submission includes data from the Phase 2b ReNeu trial, a multi-center, open-label study t
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- 11/2/23 - Beat
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Sec Filings
- 4/5/24 - Form ARS
- 4/5/24 - Form DEFA14A
- 4/5/24 - Form DEF
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