PRAX
Relutrigine
FDA PDUFA Target Action Date · Praxis Precision Medicines, Inc.
Sunday, December 27, 2026
172 days away
PDUFA date extended 3 months from Sept 27, 2026 to Dec 27, 2026 (announced June 29, 2026). FDA deemed Praxis's submission of additional sensitivity analyses of existing clinical data a 'major amendment,' extending the review clock. No new clinical studies requested; FDA cited no safety or manufacturing concerns; review remains active. Drug Information
- Drug Name
- Relutrigine (CT.gov)
- Application Type
- NDA
- FDA Designations
- BreakthroughOrphan DrugPriority Review
- Indication
- SCN2A/SCN8A developmental & epileptic encephalopathies
Filing Details
- Company
- Praxis Precision Medicines, Inc.
- Stock Ticker
- PRAX
- SEC CIK
- 0001689548
- Source
- SEC 8-K →
What is a PDUFA Date?
A PDUFA (Prescription Drug User Fee Act) date is the FDA's target deadline to complete review of a drug application. The FDA aims to make an approval decision by this date.
- Standard Review: 10 months from filing acceptance
- Priority Review: 6 months from filing acceptance
- Possible Outcomes: Approval, Complete Response Letter (CRL), or extension
Track All FDA Decisions
View all upcoming PDUFA dates and AdCom meetings on our FDA Calendar.
View FDA Calendar →Data sourced from SEC EDGAR filings. Last updated: 2026-06-29. Report an issue