Investing.com -- Shares of Chimerix (NASDAQ: NASDAQ:CMRX) climbed 12.5% as the company announced the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) for dordaviprone, a potential treatment for recurrent H3 K27M-mutant diffuse glioma. The FDA has granted the application Priority Review with a Prescription Drug User Fee Act (PDUFA) target action date set for August 18, 2025.
The biopharmaceutical company, which focuses on developing medicines for patients with deadly diseases, stated that the FDA does not anticipate convening an advisory committee meeting to discuss the application. This news marks a critical step for Chimerix in its effort to bring the first specific medicine to patients diagnosed with this type of high-grade glioma, a condition with limited treatment options and a challenging prognosis.
Mike Andriole, Chief Executive Officer of Chimerix, expressed the company’s commitment to working swiftly with the FDA to facilitate the review process, as well as preparing for a potential commercial launch to ensure the drug’s rapid availability for patients in need. Dordaviprone has already garnered several designations that underscore its potential impact, including Rare Pediatric Disease Designation and Fast-Track Designation in the United States, as well as Orphan Drug Designation in the United States, Europe, and Australia.
Dordaviprone, also known as ONC201, is a novel first-in-class small molecule that targets the mitochondrial protease ClpP and dopamine receptor D2 (DRD2). Chimerix’s most advanced clinical-stage development program is currently focused on the development of dordaviprone for H3 K27M-mutant glioma, with ongoing Phase 1 dose escalation studies to evaluate its safety and pharmacokinetics.
The company’s announcement today reflects a positive development in the regulatory pathway for dordaviprone, potentially positioning Chimerix at the forefront of treatment for this rare and aggressive form of brain cancer. With the stock’s movement reflecting the market’s optimistic response to the FDA’s acceptance and Priority Review, investors are closely monitoring Chimerix’s progress towards addressing the unmet medical needs of patients with H3 K27M-mutant diffuse glioma.
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