Praxis shares surge 36.86% after hours on FDA pre-NDA alignment and EMBOLD trial efficacy halt.

Praxis Precision Medicines (NASDAQ: PRAX) surged 36.86% in after-hours trading following multiple positive developments. The company announced successful completion of a pre-NDA meeting with the FDA for ulixacaltamide, aligning on NDA submission plans for its essential tremor treatment, with submission expected in early 2026. Additionally, Praxis reported that its EMBOLD study of relutrigine for SCN2A/SCN8A developmental and epileptic encephalopathies was stopped early due to positive efficacy results, with interim data triggering regulatory optimism. The FDA confirmed a meeting to discuss relutrigine’s NDA pathway, while topline results were set for presentation at the American Epilepsy Society Annual Meeting. These milestones highlighted regulatory progress and clinical success in addressing unmet medical needs, driving investor confidence in Praxis’ pipeline and commercial potential.