ODINSIGNAL JOURNAL · NEWS & EVENTS
FDA sets Dec 27 2026 target for Praxis Precision’s relutrigine
Praxis Precision Medicines’ relutrigine for developmental epileptic encephalopathies has a revised FDA PDUFA target date of Dec 27 2026.
Praxis Precision Medicines’ investigational drug relutrigine is under FDA review for developmental epileptic encephalopathies linked to SCN2A and SCN8A mutations. In June 2026 the agency extended the review period by three months, setting a new PDUFA target action date of December 27 2026 Biopharma Transcript PDUFA calendar. The decision deadline now marks the latest point at which the FDA will announce approval, request additional data, or deny the application.
Stakeholders will monitor the December deadline for the outcome of this priority‑review NDA.
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