Chimerix Submits NDA For Dordaviprone In Glioma Treatment

Chimerix is a biopharmaceutical company focused on developing life-saving treatments for severe diseases. The firm has announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for dordaviprone. The application seeks accelerated approval for the drug as a treatment for recurrent H3 K27M-mutant diffuse glioma in the U.S. 

Mike Andriole, Chief Executive Officer of Chimerix, said in a statement, “This NDA submission marks a pivotal moment for Chimerix in our mission to bring this potentially life-altering drug to patients diagnosed with recurrent H3 K27M-mutant diffuse glioma. With this submission, we now turn our attention to preparing for a potential commercial launch in the U.S. next year. To maximize availability and access of dordaviprone at launch, we have enhanced our commercial capabilities across multiple functions, including market access, distribution, reimbursement, patient services, marketing and commercial operations, all supported by a robust manufacturing and quality management system.”

Chimerix has also requested Priority Review, which, if granted, could result in a six-month FDA review period, with a potential decision under the Prescription Drug User Fee Act (PDUFA) expected in the third quarter of 2025. Additionally, dordaviprone has received a Rare Pediatric Disease Designation for this type of glioma. Chimerix has applied for a Rare Pediatric Disease Priority Review Voucher (PRV) as part of the NDA submission.

Michelle LaSpaluto, Chief Financial Officer of Chimerix, commented, “We also entered into a credit facility of up to $30 million with Silicon Valley Bank providing access to additional capital during this upcoming investment cycle and helping ensure dordaviprone availability to as many patients as possible, as quickly as possible, if approved. We are grateful to our partners at Silicon Valley Bank for their long-term support of Chimerix. This credit facility provides valuable financial optionality leading up to, and through, a potential U.S. launch of dordaviprone.”

Separately, Chimerix has secured a revised and restated loan and security agreement with Silicon Valley Bank (SVB), now a division of First-Citizens Bank, for up to $30 million. Under this agreement, the company can access up to $20 million through February 28, 2026, with the possibility of an additional $10 million available until February 28, 2027, pending SVB’s approval. No funds have been drawn from this loan facility yet.