Chimerix

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Chimerix plans to submit a complete New Drug Application (NDA) for dordaviprone seeking accelerated approval for recurrent H3 K27M-mutant diffuse glioma in the U.S. before year-end. The stock is trading higher on strong volume, reflecting recent program milestones and supportive data discussed with the FDA. Chimerix aims for a Priority Review, potentially leading to a PDUFA action date in Q3 2025. Dordaviprone has received Rare Pediatric Disease Designation.

Chimerix plans to submit an NDA for dordaviprone as a treatment for recurrent H3 K27M-mutant diffuse glioma, with potential approval in Q3 2025, following extensive FDA discussions and program milestones.

Chimerix plans to submit an NDA for dordaviprone as a treatment for recurrent H3 K27M-mutant diffuse glioma, aiming for potential approval in Q3 2025. The submission follows productive pre-NDA interactions with the FDA, supported by Phase 3 and 2 data, including a 28% objective response rate under RANO 2.0 criteria. Chimerix will request Priority Review, anticipating a potential PDUFA action date in Q3 2025.

Chimerix plans to submit an NDA for dordaviprone as a treatment for recurrent H3 K27M-mutant diffuse glioma, aiming for potential approval in Q3 2025. The submission follows productive pre-NDA interactions with the FDA and includes data from the Phase 3 ACTION study and Phase 2 efficacy analysis. Chimerix expects dordaviprone to significantly impact treatment options for this aggressive brain cancer.

Chimerix plans to submit a complete New Drug Application (NDA) seeking accelerated approval for dordaviprone as a treatment for recurrent H3 K27M-mutant diffuse glioma in the U.S. before year-end. If approved, dordaviprone could be the first FDA-approved therapy for this lethal disease.

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Chimerix announced updated Phase 2 results for dordaviprone in recurrent H3 K27M-mutant diffuse midline glioma, showing a 28.0% overall response rate, median time to response of 4.6 months, and median duration of response of 10.4 months using RANO 2.0 criteria. The company plans to include these results in their upcoming New Drug Application to Australian regulators and will present the findings at the 2024 SNO Annual Meeting.