PRAX PDUFA Date: Relutrigine Updated August 19, 2026 ยท next 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 date 2026-12-27
Drug / candidate Relutrigine (PRAX-562)
Indication Developmental epileptic encephalopathies (DEEs)
Company Praxis Precision Medicines Inc.
Market-cap tier Large
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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).
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