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BioWorld - Tuesday, June 23, 2026
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Home » Early FDA wins: Corcept’s Lifyorli, Denali’s Avlayah
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Early FDA wins: Corcept’s Lifyorli, Denali’s Avlayah

March 25, 2026
By Karen Carey
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The U.S. FDA approved Corcept Therapeutics Inc.’s oral, selective glucocorticoid receptor antagonist, Lifyorli (relacorilant), nearly four months ahead of schedule for adults with platinum-resistant epithelial ovarian, fallopian tube or primary peritoneal cancer. A short time after the agency approved Lifyorli, it cleared Denali Therapeutics Inc.’s Avlayah (tividenofusp alfa) under the accelerated approval pathway for mucopolysaccharidosis II, also called Hunter syndrome, ahead of the April 5 PDUFA date.
BioWorld Regulatory Cancer Endocrine/metabolic Enzyme Small molecule U.S. FDA

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