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