Praxis Precision Medicines Inc. announced plans to file a New Drug Application (NDA) for relutrigine in early 2026, following successful discussions with the FDA. The application will be based on efficacy and safety data from the EMBOLD study, which demonstrated that relutrigine provided statistically significant and clinically meaningful improvements in children with SCN2A and SCN8A developmental and epileptic encephalopathies (DEEs). The company reported that relutrigine showed robust, short- and long-term improvements in motor seizures and maintained seizure freedom in some patients, alongside a favorable safety profile. These results have already been collected and discussed with the FDA.
Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Praxis Precision Medicines Inc. published the original content used to generate this news brief via GlobeNewswire (Ref. ID: GNW9600413-en) on December 11, 2025, and is solely responsible for the information contained therein.