Today, Chimerix, Inc. (NASDAQ: CMRX) shares are surging 164.74% in pre-market trade to $2.29, gaining ground on the US stock charts. This positive trend comes after it was revealed that it will apply for fast FDA clearance for its experimental medication, dordaviprone, to treat recurrent H3 K27M-mutant diffuse glioma.
New Drug Application Submission Plans
Chimerix has stated that it would file a New Drug Application (NDA) for dordaviprone before the end of the year after lengthy talks with the FDA. For a rare and aggressive type of brain cancer that significantly restricts patients’ treatment options, the application seeks expedited clearance for this prospective therapy. If approved, dordaviprone might revolutionize the way that patients with this deadly illness are treated by giving them access to a significant new therapeutic alternative.
A Collaborative Approach to Accelerated Access
Chimerix’s efforts to bring dordaviprone to market have involved extensive collaboration with the FDA, experts in the field, and patient advocacy groups. CMRX’s engagement has aimed at speeding up access to this potentially life-saving treatment for individuals suffering from H3 K27M-mutant diffuse gliomas, a group of tumors that affect more than 2,000 patients annually in the U.S., including children and young adults.
Key Data and Regulatory Milestones
Chimerix has shared important data supporting the potential accelerated approval of dordaviprone, including the promising results from the Phase 2 study and the ongoing Phase 3 ACTION trial. Notable results include a median duration of response of 10.4 months and an objective response rate of 28% in glioma patients.
Along with a request for FDA Priority Review, Chimerix (CMRX) plans to provide a thorough safety database and in-depth pharmacological research in their NDA. The NDA may result in a decision in the third quarter of 2025 if it is approved. Dordaviprone has already received Rare Pediatric Disease Designation, and Chimerix plans to apply for a Rare Pediatric Disease Priority Review Voucher as part of the NDA submission.
