Chimerix Announces FDA Acceptance and Priority Review of New Drug Application for Dordaviprone as Treatment for Recurrent H3 K27M-Mutant Diffuse Glioma

Core Insights - The FDA has accepted Chimerix's New Drug Application for dordaviprone, targeting accelerated approval for recurrent H3 K27M-mutant diffuse glioma, with a PDUFA target action date of August 18, 2025 [1][2] - Dordaviprone has received multiple designations, including Rare Pediatric Disease Designation and Fast-Track Designation, enhancing its potential for expedited review and approval [2][4] Company Overview - Chimerix is a biopharmaceutical company focused on developing medicines that improve and extend the lives of patients with serious diseases [4] - The company is conducting Phase 1 dose escalation studies for another compound, ONC206, to evaluate safety and pharmacokinetics [4] Product Information - Dordaviprone (ONC201) is a first-in-class small molecule that selectively targets mitochondrial protease ClpP and dopamine receptor D2 (DRD2) [3]