Chimerix Submits Dordaviprone New Drug Application for Accelerated Approval to U.S. FDA for Patients with Recurrent H3 K27M-Mutant Diffuse Glioma

Core Viewpoint - Chimerix has submitted a New Drug Application (NDA) to the FDA for accelerated approval of dordaviprone as a treatment for recurrent H3 K27M-mutant diffuse glioma, marking a significant step in the company's mission to improve patient outcomes [1][4][8] Financial Developments - The company has entered into an amended loan and security agreement with Silicon Valley Bank for up to $30 million, allowing for a drawdown of $20 million until February 28, 2026, with an additional $10 million available upon request until February 28, 2027, subject to approval [2][11] - No draws have been made on this facility to date, providing the company with financial flexibility leading up to the potential U.S. launch of dordaviprone [2][11] Regulatory and Development Updates - Chimerix has requested Priority Review for the NDA, which, if granted, could lead to a six-month FDA review period and a potential Prescription Drug User Fee Act (PDUFA) action date in the third quarter of 2025 [4] - Dordaviprone has received Rare Pediatric Disease Designation for H3 K27M-mutant glioma and the company has applied for a Rare Pediatric Disease Priority Review Voucher as part of the NDA submission [4] Product Information - Dordaviprone (ONC201) is a novel first-in-class small molecule that selectively targets mitochondrial protease ClpP and dopamine receptor D2 (DRD2) [9] - The company is conducting Phase 1 dose escalation studies of ONC206 to evaluate safety and pharmacokinetic data [12] Strategic Focus - The company is enhancing its commercial capabilities across various functions, including market access, distribution, reimbursement, patient services, marketing, and commercial operations, in preparation for a potential launch of dordaviprone in the U.S. next year [8]