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mirdametinib

SpringWorks Therapeutics · $SWTX

Priority Review Orphan Drug Rare Pediatric Disease NDA

PDUFA Date

July 10, 2026

Time Remaining

108 days

Review Type

Priority (6 mo)

90%

Baseline PoA

Historical NDA
approval rate

Dynamic PoA

Coming soon
xAI Sentiment

Indication

NF1-associated plexiform neurofibromas (NF1-PN)

Key Notes

MEK inhibitor for NF1-associated tumors. ReNeu trial data in adults and pediatric patients.

⚠️ Not Investment Advice: This information is provided for educational purposes only. PDUFA dates are FDA target action dates, not guaranteed approval dates. The FDA may extend the review period, issue Complete Response Letters, or take unexpected actions. Probability of approval scores are based on historical base rates and do not account for drug-specific factors. Always consult a financial advisor before making investment decisions.

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