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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Disha is a content writer at PharmaShots. She is passionate and curious about recent updates and developments in MedTech and Pharma industry. She covers news related to clinical trial results and updates. She can be contacted at connect@pharmashots.com.
