PDUFA extended for Praxis relutrigine in SCN2A / SCN8A developmental and epileptic encephalopathies
- Sponsor
- Praxis Precision Medicines $PRAX
- Drug
- relutrigine
- Indication
- SCN2A and SCN8A developmental and epileptic encephalopathies (DEEs)
FDA extended by three months the review period for Praxis Precision Medicines's relutrigine NDA, updating the PDUFA target action date from September 27, 2026 to December 27, 2026. Praxis submitted additional sensitivity analyses of existing clinical data, which FDA classified as a 'major amendment'. FDA raised no new safety or manufacturing concerns and requested no additional clinical studies.
What this means
Relutrigine is an experimental drug developed by Praxis Precision Medicines to treat rare, severe childhood epilepsies caused by mutations in the SCN2A and SCN8A genes. On June 29, 2026, the FDA extended its review of Praxis's application by three months, moving the decision deadline from September 27, 2026 to December 27, 2026. The extension was granted because Praxis submitted extra analyses of its existing clinical data — no new studies were requested, and the FDA did not raise safety or manufacturing concerns. Patients and families waiting for this potential first targeted treatment will need to wait a few months longer for the decision.