Praxis Precision Medicines Announces FDA Acceptance of New Drug Application for Ulixacaltamide HCl in Patients with Essential Tremor
Praxis Precision Medicines announced that the FDA has accepted for review the New Drug Application for ulixacaltamide HCl to treat essential tremor in adults. The FDA set a PDUFA target action date of January 29, 2027, and no advisory committee meeting is planned. The NDA is supported by positive Phase 3 Essential3 trial results showing efficacy an…