Chimerix plans to submit a new drug application (NDA) for dordaviprone to treat recurrent H3 K27M-mutant diffuse glioma by year-end 2024. The company will seek accelerated approval from the FDA, with a potential PDUFA date in Q3 2025. The NDA will include data from a 50-patient primary efficacy analysis showing a 28% objective response rate by RANO 2.0 criteria.The submission will also include an application for a Rare Pediatric Disease Priority Review Voucher. Dordaviprone has received Orphan Drug and Fast Track designations from the FDA. Chimerix's Phase 3 ACTION study in newly diagnosed patients has substantial enrollment across 150+ sites globally.Additionally, Chimerix expects to determine the recommended Phase 2 dose for ONC206, its second-generation compound, by early 2025. The company had $152 million in capital as of September 30, 2024, to fund operations and potential growth opportunities.

Chimerix plans to submit a new drug application (NDA) for dordaviprone to treat recurrent H3 K27M-mutant diffuse glioma by year-end 2024. The company will seek accelerated approval from the FDA, with a potential PDUFA date in Q3 2025. The NDA will include data from a 50-patient primary efficacy analysis showing a 28% objective response rate by RANO 2.0 criteria.The submission will also include an application for a Rare Pediatric Disease Priority Review Voucher. Dordaviprone has received Orphan Drug and Fast Track designations from the FDA. Chimerix's Phase 3 ACTION study in newly diagnosed patients has substantial enrollment across 150+ sites globally.Additionally, Chimerix expects to determine the recommended Phase 2 dose for ONC206, its second-generation compound, by early 2025. The company had $152 million in capital as of September 30, 2024, to fund operations and potential growth opportunities.