Essential tremor is a common movement disorder characterized mainly by bilateral action or postural tremor, most often involving the hands and forearms. Symptoms are usually progressive and can cause functional impairment and social disability despite generally preserved life expectancy. Both sporadic and familial forms occur.
The FDA cleared neuromodulation devices from Epineuron, Aneuvo and Encora Therapeutics. The products address peripheral nerve surgery, spinal cord injury neurorehabilitation and essential tremor.
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.
Biotech investors are closely watching cystic fibrosis drug trials, rare-disease therapies and regulatory catalysts. Sionna Therapeutics is advancing a new CF drug class, while Praxis Precision Medicines targets essential tremor. FDA staffing challenges add uncertainty to approval timelines.
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.
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 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.
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.
| NCT ID | Title | Status | Phase |
|---|---|---|---|
| NCT07774598 |
Non-Invasive Neuromodulation for Essential Tremor: Long-Term Safety and Effectiveness Study |
RECRUITING | NA |
| NCT07721272 |
Human Cognition During Surgery: Stimulation-based and Cholinergic Modulation |
NOT_YET_RECRUITING | EARLY_PHASE1 |
| NCT07599592 |
Open Label Study for the Use of Low Intensity Focused Ultrasound for Essential Tremor |
RECRUITING | EARLY_PHASE1 |
| NCT07574164 |
Closed-loop TMS for Tremor |
RECRUITING | NA |
| NCT07531238 |
Transcranial Temporal Interference Stimulation (tTIS) To Modulate Essential Tremor |
NOT_YET_RECRUITING | NA |
| NCT07508696 |
Cerebellar Research in Ultrasound Stimulation |
NOT_YET_RECRUITING | NA |
| NCT07455760 |
Investigating Subcortical Contributions to Speech Sequencing in Deep Brain Stimulator Recipients |
RECRUITING | NA |
| NCT07446192 |
Magnetoencephalography (MEG) Pilot Study |
RECRUITING | NA |
| NCT07433699 |
Image-Guided DBS Programming |
NOT_YET_RECRUITING | NA |
| NCT07428447 |
Analysis of Cutaneous Phosphorylated Alpha-Synuclein to Identify Patients at Risk of Progressing From Essential Tremor to Parkinson's Disease |
RECRUITING |
