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mirdametinib

SpringWorks Therapeutics · $SWTX
Priority Review Orphan Drug Rare Pediatric Disease NDA
PDUFA Date
July 10, 2026
Date Status
30d ago (past)
Review Type
Priority (6 mo)
93%
Baseline PoA
Orphan/rare disease designation approval rate
Based on FDA historical approval rates by submission type (2015–2025)
Dynamic PoA
Coming soon
xAI Sentiment

FDA Decision

✅
✓ FDA Approved
Decision issued: July 17, 2026
FDA Approved on 2026-07-17 (NDA217677). Source: FDA Drugs@FDA database.
Source: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=217677

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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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