CMRX Stock Skyrockets in 3 Months: Here's What You Should Know

Core Viewpoint - Chimerix's shares have surged significantly due to the submission of a new drug application for dordaviprone, a potential treatment for recurrent H3 K27M-mutant diffuse glioma, with a notable increase of 323.7% over the past three months [1] Company Developments - Chimerix has submitted a new drug application (NDA) to the FDA for dordaviprone, seeking accelerated approval for treating H3 K27M-mutant diffuse glioma [1][2] - The company has requested Priority Review status for the NDA, which could shorten the review period to six months, with a final decision expected in Q3 2025 [2] - Dordaviprone has received Rare Pediatric Disease Designation in the U.S. and the company is also seeking a Rare Pediatric Disease Priority Review Voucher [3] - Chimerix has amended its loan agreement with Silicon Valley Bank, securing up to $30 million in funding to support the potential launch of dordaviprone [8] Clinical Data and Pipeline - The NDA submission is supported by a phase II study showing an objective response rate of 28% in a 50-patient analysis, with a median duration of response of 10.4 months [5][6] - Chimerix is conducting a phase III ACTION study for dordaviprone, currently enrolling patients at over 145 sites in 15 countries, with interim survival data expected in Q3 2025 [9] - The company is also developing another candidate, ONC206, for advanced central nervous system tumors [10] Market Context - H3 K27M-mutant gliomas affect over 2,000 patients annually in the U.S., and if approved, dordaviprone would be the first FDA-approved treatment for this aggressive disease [7] - Chimerix's shares have outperformed the industry, increasing 380.7% over the past six months compared to a 9.9% decline in the industry [4]