SpringWorks Therapeutics Announces Topline Results From The Phase 2b ReNeu Trial Of Mirdametinib In NF1-PN
Portfolio Pulse from Benzinga Newsdesk
SpringWorks Therapeutics announced positive topline results from the Phase 2b ReNeu trial of Mirdametinib for NF1-PN, showing a 52% response rate in pediatric patients and 41% in adults. The treatment led to significant improvements in patient-reported outcomes and was well tolerated with low rates of severe adverse events. Additional data will be presented at a medical conference, and an NDA submission to the U.S. FDA is planned for the first half of 2024. The company will host a conference call to discuss these results.
November 16, 2023 | 11:33 am
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POSITIVE IMPACT
SpringWorks Therapeutics reported strong Phase 2b trial results for Mirdametinib, with high response rates and good tolerance, indicating potential for FDA approval and positive market reception.
The positive trial results are likely to be viewed favorably by investors, as they suggest a strong potential for FDA approval and future revenue growth. The announcement of an upcoming NDA submission adds to the positive outlook, potentially leading to an increase in the stock price in the short term.
CONFIDENCE 85
IMPORTANCE 90
RELEVANCE 100