The company plans to submit an application to the U.S. Food and Drug Administration for approval of Ulixacaltamide in essential tremor by early 2026.
Praxis Precision Medicines, Inc. (PRAX) announced on Thursday that patients with essential tremor treated with Ulixacaltamide in a late-stage study showed improvement in functional independence.
A 4.3 point mean improvement in the Modified Activities of Daily Living 11 (mADL11) score was observed at week 8, the company said. The score is used to assess a person’s functional independence and includes day-to-day activities. Furthermore, the effect was sustained from week 2 throughout the 12-week dosing period, it added.
Essential Tremor is the most common movement disorder, affecting roughly seven million people in the U.S. alone, according to Praxis. It is characterized by involuntary rhythmic movement in the upper limbs, with or without tremor in other body locations such as the head, vocal cords, or legs.
Praxis now plans to submit an application to the U.S. Food and Drug Administration for approval of Ulixacaltamide in essential tremor by early 2026. Shares of the company rallied 69% in the pre-market session at the time of writing.
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