Chimerix, Inc. (CMRX), a biopharmaceutical company, on Tuesday announced that the FDA has accepted its NDA for Dordaviprone or ONC201, proposed for the treatment of recurrent H3 K27M-mutant diffuse glioma.
The FDA has granted the application Priority Review, with a target action date of August 18, 2025.
This filing marks a significant milestone for Chimerix in advancing the first treatment specifically targeting this rare and aggressive form of brain cancer.
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