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Praxis(PRAX) - 2024 Q4 - Annual Results
PRAXPraxis(PRAX)2025-02-28 13:03

Clinical Development and Trials - Praxis anticipates four pivotal readouts in 2025, with three late-stage assets having blockbuster potential and four commercial assets expected by 2028[1][2]. - The Essential3 program for ulixacaltamide in essential tremor is on track for an interim analysis in Q1 2025, with an NDA filing expected in 2025[1][4]. - Enrollment in the EMBOLD study for relutrigine cohort 2 is progressing, targeting an NDA filing in 2026[1][3]. - The RADIANT study for vormatrigine is expected to provide topline results in the first half of 2025, with the POWER1 study results anticipated by the end of 2025[1][3]. - Praxis plans to re-initiate a study of ulixacaltamide in Parkinson's disease following positive results from the Essential3 program[5]. - Praxis is currently focused on the expected timing of clinical trials and regulatory submissions for its programs[18]. Financial Position - Praxis has approximately 470millionincashandinvestmentsattheendof2024,supportingoperationsinto2028[1].StudyResultsandPatientEngagementTheEMBOLDstudyforrelutrigineshoweda46470 million in cash and investments at the end of 2024, supporting operations into 2028[1]. Study Results and Patient Engagement - The EMBOLD study for relutrigine showed a 46% placebo-adjusted reduction in monthly motor seizures over 16 weeks, with 77% reduction in ongoing open-label extension[7][11]. - Over 100,000 patients have expressed interest in participating in the Essential3 program since recruitment began in November 2023[4]. - The EMPOWER observational study has enrolled over 2,000 patients to characterize seizure burden, with early results shared at the 2024 American Epilepsy Society Annual Meeting[7]. Licensing and Collaborations - UCB has licensed the KCNT1 small molecule candidate for global development, with potential milestone payments totaling up to approximately 100 million[8]. Forward-Looking Statements - The company emphasizes that its forward-looking statements are based on information currently known and should not be solely relied upon[18]. - Praxis has no obligation to publicly update or revise any forward-looking statements made[18].