NASDAQ:PRAX

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Praxis Precision Medicines Falls 16% After Epilepsy Trial Misses Primary Endpoint

Shares of Praxis Precision Medicines (NASDAQ: PRAX) fell 16% after the company reported that its Phase 2/3 POWER1 study of vormatrigine in patients with focal onset seizures failed to meet its primary efficacy endpoint.

The study evaluated vormatrigine in highly refractory epilepsy patients and measured the percent change in monthly seizure frequency. While the trial did not achieve its primary success measure, the company reported that a key secondary endpoint, the 50% responder rate, was met. Praxis also noted that seizure reduction became more pronounced during the second half of the study when patients received the higher 30 mg dose.

Investors focused primarily on the primary endpoint miss, which raises questions about the regulatory and commercial path forward for the program. In response, Praxis announced it is pausing enrollment in the ongoing POWER2 study while it reassesses the data and evaluates potential modifications to the development strategy.

Despite the disappointing efficacy outcome, management highlighted several encouraging findings. Vormatrigine was generally well tolerated, with adverse event-related discontinuations below 10%, and approximately 90% of patients receiving the drug transitioned into the open-label extension study and remain enrolled.

CEO Marcio Souza said the company was encouraged by the efficacy signal observed at the higher dose level as well as the drug's favorable safety profile. He added that Praxis remains focused on advancing its broader pipeline, including planned launches for relutrigine and ulixacaltamide.

The stock's decline reflects investor disappointment that vormatrigine failed to clear its primary hurdle, overshadowing the positive secondary endpoint results and favorable tolerability profile.
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Author
European Investor 06-02-26