(Reuters) -Praxis Precision Medicines said on Thursday its experimental drug for movement disorder helped patients improve their ability to perform daily tasks in two late-stage trials, sending its shares surging more than twofold before the bell.
The company was testing the drug, ulixacaltamide, in adults with essential tremor, a nervous system condition that causes involuntary shaking, primarily affecting the hands and arms. The condition currently has no approved treatments designed specifically for it.
The first study, which enrolled 473 patients, showed that the drug helped improve daily functioning by 4.3 points on a commonly used scale, compared to placebo.
In the second trial, patients showed superior maintenance of effect while on ulixacaltamide compared to those who switched to placebo.
This study enrolled 238 patients and they received Praxis’ drug for eight weeks. Those who improved by 3 points on the scale were then randomized to receive either placebo or continued on ulixacaltamide for an additional four weeks.
“These results give hope that ulixacaltamide could be widely used in people suffering from this condition,” said Alexander Shtilbans, co-lead investigator of the trials.
Praxis said it plans to submit its application for ulixacaltamide with the U.S. Food and Drug Administration by early 2026.
“Ulixacaltamide represents more than data on a chart — it is a real opportunity to help people regain their independence and improve their daily functioning in meaningful ways,” said Salima Brillman, co-lead investigator of the trials.
The company said the drug was generally well tolerated, with no serious side-effects linked to the treatment.
The trials allowed participants across all 50 U.S. states to join remotely, Praxis said.
(Reporting by Kamal Choudhury in Bengaluru; Editing by Shilpi Majumdar)
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