Praxis' Epilepsy Drug Too Good To Continue, FDA Meeting Up Next

Core Insights - Praxis Precision Medicines Inc. stock increased following positive results from the EMBOLD study evaluating relutrigine for SCN2A and SCN8A developmental and epileptic encephalopathies [1] - The FDA has scheduled a meeting to review the data and discuss the next steps, with Praxis planning to determine the timing for filing a New Drug Application (NDA) post-meeting [2][4] - Analyst commentary suggests relutrigine is expected to be a blockbuster drug, with increased probability of success and projected peak sales significantly raised [5][7] Study Results - The Data Monitoring Committee recommended stopping the EMBOLD study early due to efficacy [1] - Topline results from the EMBOLD study will be presented at the American Epilepsy Society Annual Meeting [3] Regulatory Developments - Praxis completed its pre-NDA meeting with the FDA, receiving written feedback and conducting an in-person meeting [3] - The company expects to submit its NDA in early 2026 after aligning with the FDA on the content [4] Analyst Insights - HC Wainwright views relutrigine as overlooked but anticipates a shift in perception following EMBOLD data [5] - The analyst increased the probability of success for relutrigine to 80% from 60% and raised projected peak sales to $2.8 billion from $760 million [6][7] - The firm maintains a Buy rating for Praxis Precision and increased the price forecast from $258 to $340 [7] Pipeline Developments - Praxis previously shared positive topline results from its Phase 2 RADIANT study, showing a median seizure reduction of approximately 56.3% in patients with focal onset seizures and generalized epilepsy [8] - The stock price rose by 30.84% to $248.56, reaching a new 52-week high [8]