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 submitted NDAs for ulixacaltamide and relutrigine to the FDA, reported cash and investments of $926 million as of December 31, 2025, and disclosed a net loss of $303.3 million for full-year 2025.
Praxis Precision Medicine reported Q4 losses of $3.50 per share, missing analyst estimates of $3.08 per share. Following the earnings announcement, analysts maintained their ratings while raising price targets across the board.
Drug Hunter's monthly molecule selections from July through December 2025 feature innovative small molecule candidates targeting pain, epilepsy, cancer, infectious diseases, and metabolic disorders, including non-opioid pain agents and precision therapies for rare conditions.