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Will FDA approve dordaviprone for recurrent H3 K27M-mutant diffuse glioma by Q3 2025?
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Chimerix Submits NDA for Dordaviprone to Treat Recurrent H3 K27M-Mutant Diffuse Glioma, Expects FDA Decision by Q3 2025
Dec 30, 2024, 08:37 PM
Chimerix, Inc. has submitted a New Drug Application (NDA) for accelerated approval of its drug, dordaviprone, to the U.S. Food and Drug Administration (FDA). The drug targets patients with recurrent H3 K27M-mutant diffuse glioma, a type of brain tumor. The FDA is expected to make a decision by the third quarter of 2025. In conjunction with the NDA submission, Chimerix entered into a credit facility of up to $30 million with Silicon Valley Bank, which will provide additional capital to ensure the availability of dordaviprone to patients, should it receive approval. The company is backed by major advocate groups focused on pediatric patients affected by this condition.
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