Praxis(PRAX) GlobeNewswire·2025-02-28 13:00Core Insights - Praxis Precision Medicines, Inc. announced an interim analysis outcome for Study 1 of the Essential3 program, recommending the study be stopped for futility due to unlikely success in meeting primary efficacy endpoints [2] - Despite the interim analysis, the company will continue both Study 1 and Study 2, with topline results expected in Q3 2025, and will decide on NDA submission based on final results [3] - The company remains focused on other development programs, including upcoming topline results from studies on focal onset seizures and generalized epilepsy, and plans to initiate a registrational study for relutrigine by mid-2025 [4] Study Updates - The Independent Data Monitoring Committee (IDMC) advised Praxis to stop Study 1 for futility, suggesting alternative analysis methods for the final dataset [2] - Praxis will continue with both Study 1 and Study 2, expecting topline results in Q3 2025 [3] Financial Overview - As of December 31, 2024, Praxis reported 81.3 million in 2023, primarily due to public offerings [9] - The company recognized collaboration revenue of 8.6 million for the full year, related to an agreement with UCB [10] - Research and development expenses rose to 18.4 million in Q4 2023, totaling $152.4 million for the year, driven by increased costs associated with the Cerebrum™ platform [11] Operational Highlights - Praxis is advancing multiple programs, including the RADIANT and POWER1 studies for focal onset seizures and generalized epilepsy, with topline results expected in 2025 [4][6] - The company has received Rare Pediatric Disease Designation for relutrigine for Dravet Syndrome, marking its third such designation [6] - The EMBOLD study is currently enrolling patients, with topline results anticipated in the first half of 2026 [6] Shareholder Information - As of December 31, 2024, Praxis had 19.4 million shares of common stock outstanding [15]