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relutrigine

Praxis Precision Medicines · $PRAX
Priority Review Breakthrough Therapy Orphan Drug Rare Pediatric Disease NDA
PDUFA Date
September 27, 2026
Time Remaining
180 days
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

Live Company Data NMS

Updated just now · Data: FMP
Current Price
$276.44 +615.05%
+$237.78 today
Day: $271.94 – $296.00
Market Cap
N/A
52-Week Range
$26.70
$356.00
Current price is at 76% of 52-week range
⚠️ Financial data is for informational purposes only. Not investment advice. Prices may be delayed.

Indication

SCN2A- and SCN8A-related developmental and epileptic encephalopathies (DEEs)

Key Notes

NDA accepted with Priority Review. PDUFA September 27, 2026 (confirmed by FDA March 30, 2026). EMBOLD registrational cohort data: relutrigine demonstrated 46–53% placebo-adjusted seizure reductions in SCN2A/SCN8A-DEEs. NaV1.6/NaV1.2 sodium channel inhibitor — precision target for gain-of-function mutations in these rare pediatric epilepsies. Second NDA from Praxis alongside ulixacaltamide (ET). EMERALD Phase 3 in broader DEEs also ongoing. Rare Pediatric Disease designation makes company eligible for PRV.
⚠️ 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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