CORCEPT WKN: 529882 ISIN: US2183521028 Kürzel: CORT Forum: Aktien Thema: Hauptdiskussion

Corcept (NASDAQ: CORT) announced that the FDA issued a Complete Response Letter for the NDA for relacorilant as a treatment for hypertension secondary to hypercortisolism. The FDA acknowledged the pivotal GRACE trial met its primary endpoint and found the GRADIENT trial provided confirmatory evidence, but concluded additional evidence of effectiveness is needed before a favorable benefit‑risk assessment can be made. Corcept said it is surprised and disappointed, remains committed to patients, and will meet with the FDA as soon as possible to discuss next steps.