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VisitWill FDA grant accelerated approval for Dordaviprone by end of 2025?
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FDA official announcements or press releases
Chimerix Submits Dordaviprone NDA for Accelerated Approval to U.S. FDA for Recurrent H3 K27M-Mutant Diffuse Glioma, Secures $30 Million Funding
Dec 30, 2024, 12:02 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 application targets patients with recurrent H3 K27M-mutant diffuse glioma, a type of brain cancer. In addition, Chimerix has entered into a credit facility of up to $30 million with Silicon Valley Bank. This funding aims to provide access to additional capital during the upcoming investment cycle and to ensure the availability of Dordaviprone to as many patients as possible, should it receive approval.
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