Tuesday after the biotech company revealed intentions to submit a New Drug Application to the U.S. Food and Drug Authority (FDA) seeking speedy clearance for dordaviprone, a therapy for recurrent H3 K27M-mutant
diffuse glioma, Chimerix (CMRX, Financial) more than doubled, rising over 220% on Tuesday.
The corporation will ask Priority Review and wants to turn in the application by the end of the year. Data from Phase 2 and Phase 3 studies, showing a 28% objective response rate and a median response duration of 10.4 months, will be included into the NDA.
Over 2,000 U.S. patients yearly suffer from severe brain cancer known as recurrent H3 K27M-mutant diffuse glioma. For this disorder, no FDA-approved treatment exists right now. Should the application be approved Priority Review Chimerix plans to start the treatment in the United States by the third quarter
of 2025.
To speed patient access to the treatment, Chimerix said it had interacted withFDA, disease experts, and advocates. To assess safety and pharmacokinetics, the business is also doing Phase 1 research on another therapy, ONC206.
