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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 in the trial, the company said. The score is used to assess a person's functional independence and evaluate a person’s ability to do 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 76% in the pre-market session at the time of writing.
On Stocktwits, retail sentiment around PRAX stock jumped from ‘bearish’ to ‘extremely bullish’ territory, while message volume increased from ‘low’ to ‘extremely high’ levels.
The company said that Ulixacaltamide was generally well-tolerated over 12 weeks of treatment, and no deaths or drug-related serious adverse events were recorded. However, discontinuations in the study were 35.6% in patients who received Ulixacaltamide as compared to 5.6% in patients who received placebo, and most discontinuations were primarily due to treatment-emergent adverse events, it said.
The company also conducted another late-stage trial where patients showed superior maintenance of effect while on Ulixacaltamide versus placebo after blinded exposure for 8 weeks with Ulixacaltamide.
PRAX stock is down by 25% this year and by about 23% over the past 12 months.
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