News Related to SCN2A- and SCN8A-Related Developmental and Epileptic Encephalopathies

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FDA accepts Praxis NDA for ulixacaltamide in essential tremor, sets Jan. 29, 2027 action date

Apr 14, 2026

The FDA accepted Praxis Precision Medicines' NDA for ulixacaltamide in essential tremor and set a Jan. 29, 2027 PDUFA date. The filing is backed by positive Phase 3 Essential3 data.

Praxis Precision Medicines Submits Two NDAs, Reports $926M Cash Position

Dec 30, 2025

Praxis Precision Medicines has submitted new drug applications for ulixacaltamide in essential tremor and relutrigine in rare epilepsies, both granted Breakthrough Therapy Designation. The company reported $926 million in cash as of December 31, 2025.