SpringWorks Therapeutics Announces FDA Approval of GOMEKLI™ (mirdametinib) for the Treatment of Adult and Pediatric Patients with NF1-PN
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SpringWorks Therapeutics has received FDA approval for GOMEKLI (mirdametinib), a treatment for NF1-PN in both adults and children. This approval is based on positive Phase 2b trial results and grants SpringWorks a rare pediatric disease priority review voucher.

February 11, 2025 | 10:45 pm
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SpringWorks Therapeutics received FDA approval for GOMEKLI, a treatment for NF1-PN, marking a significant milestone. The approval is based on successful Phase 2b trial results and includes a rare pediatric disease priority review voucher.
The FDA approval of GOMEKLI is a major achievement for SpringWorks Therapeutics, as it is the first approved treatment for NF1-PN in both adults and children. The positive Phase 2b trial results and the granting of a rare pediatric disease priority review voucher are likely to boost investor confidence and positively impact the stock price in the short term.
CONFIDENCE 100
IMPORTANCE 90
RELEVANCE 100