Chimerix Soars 220% on FDA Filing Plans for Lifesaving Brain Cancer Therapy

GuruFocus.com12-11

Tuesday after the biotech company revealed intentions to submit a New Drug Application to the U.S. Food and Drug Authority (FDA) seeking speedy clearance for dordaviprone, a therapy for recurrent H3 ...

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Data from Phase 2 and Phase 3 studies, showing a 28% objective response rate and a median response duration of 10.4 months, will be included into the NDA.GuruFocus has detected 6 Warning Signs with CMRX.Over 2,000 U.S. patients yearly suffer from severe brain cancer known as recurrent H3 K27M-mutant diffuse glioma. For this disorder, no FDA-approved treatment exists right now. 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Data from Phase 2 and Phase 3 studies, showing a 28% objective response rate and a median response duration of 10.4 months, will be included into the NDA.\n\nWarning! GuruFocus has detected 6 Warning Signs with CMRX.\n\nOver 2,000 U.S. patients yearly suffer from severe brain cancer known as recurrent H3 K27M-mutant diffuse glioma. For this disorder, no FDA-approved treatment exists right now. Should the application be approved Priority Review Chimerix plans to start the treatment in the United States by the third quarterof 2025.\nTo speed patient access to the treatment, Chimerix said it had interacted withFDA, disease experts, and advocates. 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