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Chimerix Reports the Dordaviprone’s NDA Submission to the US FDA for Recurrent H3 K27M-Mutant Diffuse Glioma

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  • Chimerix has submitted the NDA of dordaviprone (small molecule imipridone targeting the mitochondrial protease ClpP & dopamine receptor D2) to the US FDA, seeking accelerated approval for treating recurrent H3 K27M-mutant diffuse glioma
  • Chimerix has also requested priority review along with a Rare Paediatric Disease PRV as a part of submission, as the drug holds RPDD in this indication, aiming PDUFA date in Q3’25
  • Chimerix has also reported an amended & restated loan agreement with Silicon Valley Bank for up to $30M. It can draw $20M until Feb 28, 2026 & additional $10M until Feb 28, 2027 on approval. No funds have been drawn yet

Ref: Chimerix | Image: Chimerix

Related News:- MicuRx Pharmaceutical’s MRX-5 Secures the US FDA’s Orphan Drug Designation for Treating NTM Infections

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