Praxis Precision Medicines Announces Positive Pre-NDA Meeting with FDA for Ulixacaltamide in Essential Tremor

BOSTON, Dec. 04, 2025 (GLOBE NEWSWIRE) — Praxis Precision Medicines, Inc. (NASDAQ: PRAX), a clinical-stage biopharmaceutical company translating genetic insights into the development of therapies for central nervous system (CNS) disorders characterized by neuronal excitation-inhibition imbalance, today announced the successful completion of its pre-NDA (New Drug Application) meeting with the FDA, including receipt of written feedback and an in-person meeting. Praxis has gained alignment from the agency on the content of the NDA and expects to complete its NDA submission in early 2026.