Developmental and Epileptic Encephalopathy (DEE)
PRAXPraxis Precision MedicinesCatalyst overview
Research summary
This catalyst tracks a PDUFA approval decision for Relutrigine (PRAX-562) in Developmental and Epileptic Encephalopathy (DEE). The expected timing is based on the latest available company guidance and may change.
EMBOLD, EMERALD trials. 8/4/25- EMERALD study initiated; enrollment completion in 2026. 11/4/25– NDA in early 2026. 12/4/25– Interim analysis met efficacy; stopped early. Topline results at AES’25 on December 6, 2025. 12/11/25:- FDA discussion completed; NDA submission for relutrigine in DEE confirmed for Early 2026. 01/12/26:- NDA filing now expected by mid-February 2026. EMERALD DEE study completes H2 2026; supports sNDA 2027. 02/19/26:- NDA for SCN2A/SCN8A DEEs submitted. EMERALD fully enrolled H2 2026; potential sNDA 2027; launch prep accelerating. 03/30/26:- FDA accepted NDA; PDUFA September 27, 2026. EMERALD trial completion expected End Of 2026. 04/13/26:- EMERALD and EMBOLD Cohort 2 posters scheduled at AAN 2026 on April 22, 2026. 05/07/26:- FDA priority review accepted; PDUFA 27 Sept 2026 reiterated. EMERALD recruitment complete; topline Q4 2026; sNDA planned 2027. 08/06/26:- PDUFA extended to Dec 27, 2026; EMERALD topline expected Q4 2026.
Verification
Confirm timing and program details against the company announcement or filing.