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Chimerix to submit dordaviprone NDA to FDA, seeks accelerated approval

Chimerix to submit dordaviprone NDA to FDA, seeks accelerated approval

Chimerix (CMRX) announced that, following extensive dialogue with the FDA, the company plans to submit a complete new drug application, or NDA, seeking accelerated approval for dordaviprone as a treatment for recurrent H3 K27M-mutant diffuse glioma in the United States before year-end.

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