May 14, 2026
The FDA cleared neuromodulation devices from Epineuron, Aneuvo and Encora Therapeutics. The products address peripheral nerve surgery, spinal cord injury neurorehabilitation and essential tremor.
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.
Feb 24, 2026
Multiple analysts have raised price targets on Praxis Precision Medicines, with Wolfe Research initiating coverage at $500 and Guggenheim increasing its target to $800, citing strong market potential for ulixacaltamide in essential tremor.
Feb 19, 2026
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.
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.
Feb 13, 2026
Praxis Precision Medicines is preparing to submit two New Drug Applications by mid-February 2026 for ulixacaltamide and relutrigine, both holding FDA Breakthrough Therapy Designation, targeting essential tremor and epilepsy markets.