Praxis Precision Medicines Announces FDA Acceptance and Priority Review of New Drug Application for Relutrigine in Patients with SCN2A and SCN8A DEEs
Praxis Precision Medicines, Inc. (PRAX)
Company Research
Source: GlobeNewswire
FDA assigned PDUFA target action date of September 27, 2026 BOSTON, March 30, 2026 (GLOBE NEWSWIRE) -- Praxis Precision Medicines, Inc. (NASDAQ: PRAX), a fully integrated, leading central nervous system (CNS) precision neuroscience biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has accepted for priority review its New Drug Application (NDA) for relutrigine, for the treatment of SCN2A and SCN8A developmental and epileptic encephalopathies (DEEs). The FDA has set a target action date under the Prescription Drug User Fee Act (PDUFA) of September 27, 2026. “Our first FDA acceptance of an NDA submission marks a significant milestone in our evolution to a commercial-stage company and an important step toward delivering innovative, precision neuroscience therapies to patients in need. SCN2A/8A DEEs have no currently approved targeted therapies and relutrigine, if approved, would be the first disease-modifying therapy for children suffering fro
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News
- Praxis Precision Medicines (PRAX) had its "buy" rating reaffirmed by Deutsche Bank Aktiengesellschaft.MarketBeat
- Praxis Precision Medicines (PRAX) had its "buy" rating reaffirmed by Needham & Company LLC. They now have a $510.00 price target on the stock.MarketBeat
- Praxis Precision Medicines Announces FDA Acceptance of New Drug Application for Ulixacaltamide HCl in Patients with Essential TremorGlobeNewswire
- Praxis to Showcase Essential3, the First Positive Phase 3 Program in Essential Tremor, at AAN 2026GlobeNewswire
- Praxis Precision Medicines (PRAX) was upgraded by Raymond James Financial, Inc. to "strong-buy".MarketBeat
PRAX
Earnings
- 2/19/26 - Miss
PRAX
Sec Filings
- 4/14/26 - Form 8-K
- 4/6/26 - Form 8-K
- 3/27/26 - Form SCHEDULE
- PRAX's page on the SEC website