TLDR
- Praxis Precision Medicines stock surged 100% following positive Phase 3 trial results for ulixacaltamide, a treatment for essential tremor
- Study 1 showed a 4.3-point improvement in daily living activities scores at week 8, meeting the primary endpoint
- Study 2 demonstrated 55% of patients maintained treatment effects on ulixacaltamide versus 33% on placebo
- The drug was well tolerated with no serious drug-related adverse events, with common side effects including constipation, dizziness, and headache
- Praxis plans to submit a New Drug Application to the FDA by early 2026
Praxis Precision Medicines saw its stock double on October 16, 2025, after announcing successful results from two Phase 3 clinical trials testing ulixacaltamide for essential tremor. The Boston-based company reported data from its Essential3 program, which evaluated the drug in patients who had been living with the condition for an average of 30 years.
Essential tremor affects approximately 7 million people in the United States. The condition causes involuntary shaking that can interfere with daily activities.
In Study 1, a parallel-group trial, patients taking ulixacaltamide showed a mean improvement of 4.3 points from baseline in the Modified Activities of Daily Living 11 score at week 8. This result met the study’s primary endpoint with statistical significance. All key secondary endpoints in the study also reached statistical significance.
Study 2 used a randomized-withdrawal design. In this trial, 55% of patients maintained their treatment effect while taking ulixacaltamide compared to 33% of those on placebo. The drug demonstrated superior effects in maintaining disease improvement during the withdrawal phase.
Safety Profile
The company reported that ulixacaltamide was generally well tolerated across both studies. No drug-related serious adverse events occurred during the trials.
The most common side effects included constipation, dizziness, euphoric mood, brain fog, headache, paraesthesia, and insomnia. The safety profile matched results from previous trials of the drug.
Dr. Salima Brillman, co-lead investigator of the program, stated this marks the first medication designed specifically for essential tremor patients. She described the drug as an opportunity to help people regain independence and improve daily functioning.
Regulatory Plans
Praxis has submitted a pre-NDA meeting request to the FDA. The company plans to file the New Drug Application by early 2026, pending agreement with the regulatory agency.
The market responded positively to the news, with Praxis stock rising 197.86% during trading. The company’s market cap reached $1.21 billion following the announcement.
Praxis Precision Medicines operates in the pharmaceutical industry with a focus on neurological disorders. Ulixacaltamide represents the company’s primary product in development.
Analysts currently rate the stock as a buy with a $270 price target. The average trading volume for Praxis stock is 466,128 shares.
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