Shares of Praxis Precision Medicines, Inc. (NASDAQ: PRAX) surged 7.97% in Thursday's trading session following the company's announcement of positive results from two pivotal Phase 3 trials of its investigational drug ulixacaltamide for essential tremor. The stock's impressive performance underscores investor enthusiasm for the potential breakthrough in treating this common movement disorder.
The clinical-stage biopharmaceutical company reported that both studies met their primary endpoints, demonstrating statistically significant and clinically meaningful improvements in patients' daily functioning and tremor control. In the first study, which enrolled 473 patients, ulixacaltamide showed a 4.3 point mean improvement in the Modified Activities of Daily Living 11 (mADL11) score at Week 8 compared to placebo. The second study, involving 238 patients, demonstrated superior maintenance of effect in patients continuing ulixacaltamide treatment versus those switched to placebo.
The success of these trials positions Praxis as a frontrunner in movement disorder drug development, particularly significant given the current lack of approved treatments specifically designed for essential tremor. Marcio Souza, president and CEO of Praxis, expressed enthusiasm about the results, stating, "To all the patients living with ET, I am thrilled with the results of the Essential3 Program." The company has already submitted a pre-NDA meeting request to the FDA, with plans to submit the New Drug Application by early 2026, pending agreement with the agency. In response to these developments, several analysts have significantly raised their price targets for Praxis stock, with some projecting a potential multi-billion dollar market opportunity for ulixacaltamide.