Praxis Precision Medicines, Inc. (NASDAQ:PRAX) stock had a tumultuous trading day on Monday following the release of positive topline results from its Phase 2 RADIANT study on vormatrigine in patients with focal onset seizures and generalized epilepsy. The initial surge in stock price was quickly reversed, with the stock currently trading down approximately 9%.
The Phase 2 RADIANT study included data from 37 patients, showing a median seizure reduction of around 56.3%, with 60% of patients achieving at least a 50% reduction in seizures. Praxis President and CEO, Marcio Souza, highlighted the differentiated profile of vormatrigine as a fast-acting, once-daily oral drug with a favorable DDI profile.
Despite 23% of patients discontinuing the study, the positive results have prompted Praxis to move forward with a Phase 2/3 trial. In the trial, 54% of patients achieved a 50% seizure reduction in Week 1, increasing to 67% in Week 8. Additionally, 22% of patients experienced a 100% reduction in seizure frequency in the last month of the dataset.
Most adverse events were reported as mild to moderate and transient, with all severe and serious adverse events resolved. Praxis noted that investigators had the option to reduce background medication doses to manage adverse events, with no discontinuations observed in the six patients where this was done.
The company plans to complete the pivotal 12-week POWER1 study in the fourth quarter of 2025 and expects to initiate the POWER2 study soon based on the RADIANT results. With approximately $447 million in cash and investments, Praxis maintains a cash runway into 2028.
In July, the FDA granted Breakthrough Therapy Designation for Praxis Precision’s relutrigine for SCN2A and SCN8A developmental and epileptic encephalopathies. The EMBOLD cohort 2 pivotal trial is on track for topline results in the first half of 2026, with an NDA filing to follow.
Praxis has also initiated the EMERALD study investigating relutrigine in DEEs. Despite the stock trading lower by 9.51% to $48.95 on Monday, the company remains optimistic about its future prospects in the epilepsy treatment market.
The information presented in this article was originally sourced from Benzinga.com and all rights are reserved to Benzinga.com.
