# Relutrigine PDUFA Event: SCN2A and SCN8A developmental and epileptic encephalopathies Canonical URL: https://biopharmsignal.com/pdufa-calendar/PRAX/relutrigine-scn2a-scn8a-developmental-epileptic-encephalopathies Ticker: PRAX Company: Praxis Precision Medicines Event date: 2026-12-27 Event type: FDA Decision Stage: PDUFA Result: Pending Application type: NDA FDA decision expected after review extension. FDA extended the PDUFA target action date by three months from September 27 to December 27, 2026. ## Event Timeline ### December 27, 2026 — FDA decision expected after review extension FDA extended the PDUFA target action date by three months from September 27 to December 27, 2026. [Praxis — PDUFA review extension](https://investors.praxismedicines.com/news-releases/news-release-details/praxis-precision-medicines-announces-extension-period/) ### June 29, 2026 — FDA extended the review after a major amendment FDA classified additional sensitivity analyses of existing clinical data as a major amendment. No new clinical studies were requested, and no safety or manufacturing concerns were cited. [Praxis — PDUFA review extension](https://investors.praxismedicines.com/news-releases/news-release-details/praxis-precision-medicines-announces-extension-period/) ### March 30, 2026 — FDA accepted the NDA with Priority Review FDA accepted the application based on positive results from the EMBOLD study and initially assigned a September 27, 2026 target action date. [Praxis — NDA acceptance and initial PDUFA date](https://investors.praxismedicines.com/news-releases/news-release-details/praxis-precision-medicines-announces-fda-acceptance-and-priority) ### February 19, 2026 — Praxis reported submitting the NDA Praxis submitted the application based on the efficacy and safety results from the EMBOLD registrational cohort. [Praxis — Relutrigine NDA submission](https://investors.praxismedicines.com/news-releases/news-release-details/praxis-precision-medicines-provides-corporate-update-and-18/) ### December 8, 2025 — Detailed EMBOLD registrational results were reported At the American Epilepsy Society meeting, Praxis reported a 53% placebo-adjusted reduction in seizures, increased motor-seizure-free days and broad functional improvements. [Praxis — Detailed EMBOLD results at AES 2025](https://investors.praxismedicines.com/news-releases/news-release-details/praxis-aes-wrap-best-class-potential-across-rare-pediatric-and/) ### December 4, 2025 — EMBOLD stopped early for efficacy The Data Monitoring Committee recommended stopping the registrational cohort after a successful interim analysis. [Praxis — Positive EMBOLD registrational results](https://investors.praxismedicines.com/news-releases/news-release-details/praxis-precision-medicines-announces-positive-results-embold/) ### July 17, 2025 — FDA granted Breakthrough Therapy designation FDA granted the designation based on Phase 2 EMBOLD and open-label-extension results in SCN2A and SCN8A developmental and epileptic encephalopathies. [Praxis — Breakthrough Therapy designation](https://investors.praxismedicines.com/news-releases/news-release-details/praxis-precision-medicines-receives-fda-breakthrough-therapy/) ### September 3, 2024 — Initial Phase 2 EMBOLD results were reported Relutrigine produced a 46% placebo-adjusted reduction in monthly motor seizures, while more than 30% of treated patients achieved seizure-free periods. [Praxis — Initial EMBOLD topline results](https://investors.praxismedicines.com/news-releases/news-release-details/praxis-precision-medicines-announces-positive-topline-results-0/) ## Regulatory Designations - Priority Review FDA: [Praxis — NDA acceptance and Priority Review](https://investors.praxismedicines.com/news-releases/news-release-details/praxis-precision-medicines-announces-fda-acceptance-and-priority) - Breakthrough Therapy FDA: [Praxis — Relutrigine regulatory designations](https://investors.praxismedicines.com/news-releases/news-release-details/praxis-precision-medicines-announces-fda-acceptance-and-priority) - Orphan Drug FDA: [Praxis — Relutrigine regulatory designations](https://investors.praxismedicines.com/news-releases/news-release-details/praxis-precision-medicines-announces-fda-acceptance-and-priority) - Orphan Drug EMA: [Praxis — Relutrigine regulatory designations](https://investors.praxismedicines.com/news-releases/news-release-details/praxis-precision-medicines-announces-fda-acceptance-and-priority) - Rare Pediatric Disease FDA: [Praxis — Relutrigine regulatory designations](https://investors.praxismedicines.com/news-releases/news-release-details/praxis-precision-medicines-announces-fda-acceptance-and-priority) ## Related Pages - PRAX PDUFA calendar: https://biopharmsignal.com/pdufa-calendar/PRAX.md - PRAX company profile: https://biopharmsignal.com/company/PRAX.md - PDUFA calendar: https://biopharmsignal.com/pdufa-calendar.md ## Related News - 2026-09-03 — Praxis Precision Medicines, Inc. Announces Inducement Grants Under Nasdaq Listing Rule 5635(c)(4): https://biopharmsignal.com/news/PRAX/praxis-precision-medicines-inc-announces-inducement-grants-under-nasdaq-listing--df4d1f8b.md - 2026-08-06 — Praxis Precision Medicines Provides Corporate Update and Reports Second Quarter 2026 Financial Results: https://biopharmsignal.com/news/PRAX/praxis-precision-medicines-provides-corporate-update-and-reports-second-quarter--02c621cf.md - 2026-08-04 — Praxis Precision Medicines, Inc. Announces Inducement Grants Under Nasdaq Listing Rule 5635(c)(4): https://biopharmsignal.com/news/PRAX/praxis-precision-medicines-inc-announces-inducement-grants-under-nasdaq-listing--e04d211e.md - 2026-07-30 — Praxis Precision Medicines to Report Second Quarter 2026 Financial Results on Thursday, August 6, 2026: https://biopharmsignal.com/news/PRAX/praxis-precision-medicines-to-report-second-quarter-2026-financial-results-on-th-16ae1983.md - 2026-07-07 — Praxis Precision Medicines and Remagine Labs Announce Strategic Collaboration to Develop Transdermal Ulixacaltamide for Essential Tremor: https://biopharmsignal.com/news/PRAX/praxis-precision-medicines-and-remagine-labs-announce-strategic-collaboration-to-0ffd9b54.md