PRAX PDUFA Date: Relutrigine Page updated September 2, 2026 · next FDA decision on the calendar · Data as of Oct 11, 2026 9:31 PM ET FDA decision (PDUFA) target Dec 27, 2026 · Praxis Precision Medicines Inc. · Developmental epileptic encephalopathies (DEEs)
Key facts FDA PDUFA target date 2026-12-27
Drug / candidate Relutrigine (PRAX-562)
Indication Developmental epileptic encephalopathies (DEEs)
Company Praxis Precision Medicines Inc.
Market-cap tier Large
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).
Not affiliated with or endorsed by the FDA. pdufa.bio is an independent publication with no affiliation with, endorsement by, sponsorship by, or connection to the U.S. Food and Drug Administration or any other government agency. “FDA”, “PDUFA” and all company, drug and ticker names are used descriptively and remain the property of their respective owners.Informational and educational purposes only. Not investment advice. Nothing on this page is investment, legal, tax or medical advice, or an offer or solicitation to buy or sell any security. pdufa.bio is not a registered investment adviser or broker-dealer and does not recommend trades or publish individual-drug approval probabilities. Verify every date and outcome against primary FDA, SEC or company filings. Data is provided as is, without warranty of any kind, and past behaviour does not predict future outcomes.