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Chimerix To Submit Dordaviprone For Accelerated Approval To U.S. FDA For Patients With Recurrent H3 K27M-Mutant Diffuse Glioma Before Year-End

Benzinga·12/09/2024 21:01:57
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Potential Approval in Q3 2025 in Recurrent H3 K27M-Mutant Diffuse Glioma

Submission Plan Follows Productive and Collaborative Pre-NDA Interactions with FDA

Company to Host Conference Call on Tuesday, December 10 at 8:30 AM ET

DURHAM, N.C., Dec. 09, 2024 (GLOBE NEWSWIRE) -- Chimerix (NASDAQ:CMRX), a biopharmaceutical company whose mission it is to develop medicines that meaningfully improve and extend the lives of patients facing deadly diseases, today announced that, following extensive dialogue with the U.S. Food and Drug Administration (FDA), the Company plans to submit a complete New Drug Application (NDA) seeking accelerated approval for dordaviprone as a treatment for recurrent H3 K27M-mutant diffuse glioma in the United States before year-end.