FDA official announcements and Chimerix Inc. press releases

Chimerix Inc. Targets FDA Approval for Dordaviprone in Rare Brain Cancer, Shares Surge 164.4%

Dec 10, 2024, 12:27 PM

Chimerix Inc. ($CMRX) has announced plans to submit a New Drug Application (NDA) for its drug Dordaviprone, targeting recurrent H3 K27M-mutant diffuse glioma, to the U.S. Food and Drug Administration (FDA) before year-end. The company has engaged in productive discussions with the FDA, aiming for accelerated approval which could lead to a potential U.S. launch in the third quarter of 2025 if approved. Chimerix's market capitalization was $80 million before the news, with $150 million in cash reserves, and the company is also eligible to apply for a Rare Pediatric Disease Priority Review Voucher (PRV) with its NDA submission. The treatment targets a rare form of brain cancer affecting approximately 2,000 patients in the U.S. annually, with no current effective therapies available. Chimerix shares surged 164.4% pre-market following the announcement. The company will host a conference call to discuss the submission plan, and it anticipates having phase 3 data around the time the FDA makes its decision, potentially accelerating market entry by about two years. Chimerix also sees potential for substantial ex-USA partnerships, given the global market size of approximately 5,000 patients.