pdufa.bio
HomePDUFA Calendar › PRAX

PRAX PDUFA Date: Relutrigine

Updated ยทnext FDA decision on the calendar
FDA decision (PDUFA) target Dec 27, 2026 · Praxis Precision Medicines Inc. · Developmental epileptic encephalopathies (DEEs)

Key facts

FDA PDUFA target date2026-12-27
Drug / candidateRelutrigine (PRAX-562)
IndicationDevelopmental epileptic encephalopathies (DEEs)
CompanyPraxis Precision Medicines Inc.
Market-cap tierLarge

New to FDA decisions? Read what a PDUFA date is and how often the FDA approves drugs.

See the full 2026 PDUFA calendar →All December 2026 PDUFA dates →

FAQ

When is the PRAX PDUFA date?
The FDA PDUFA target date for PRAX (Praxis Precision Medicines Inc.) is 2026-12-27 for Relutrigine (PRAX-562). Dates are company/FDA-sourced and can slip. Verify against primary filings.
What is PRAX's drug Relutrigine?
Relutrigine (PRAX-562) is Praxis Precision Medicines Inc.'s candidate under FDA review for Developmental epileptic encephalopathies (DEEs).