Corcept Therapeutics Reports the US FDA Approval of Lifyorli (Relacorilant) to Treat Platinum-Resistant Ovarian Cancer

Shots: The US FDA has approved Lifyorli (relacorilant) + nab-paclitaxel for the treatment of adults with epithelial ovarian, fallopian tube, or primary peritoneal cancer who have received 1-3 prior systemic therapies, ≥1 of which included Avastin NDA was supported by P-III (ROSELLA) assessing Lifyorli + nab-paclitaxel vs nab-paclitaxel alone in the above-mentioned pts (n=381) with no…

ByRidhi Rastogi13 hours ago

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Corcept Therapeutics Reports P-III (ROSELLA) Trial Data on Relacorilant for Platinum-Resistant Ovarian Cancer (PROC)

Shots: Corcept has reported P-III (ROSELLA) trial data assessing relacorilant (PO, GR antagonist) + nab-paclitaxel vs nab-paclitaxel in 381 pts with PROC Trial met its 1EP of OS, showing a 35% reduction in death risk (mOS: 16 vs 11.9mos.), & previously met its PFS endpoint with a 30% reduction in progression risk, as presented at…

ByRidhi RastogiJanuary 23, 2026

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Corcept Receives US FDA Complete Response Letter for Relacorilant in Hypercortisolism

Shots: The US FDA has issued a Complete Response Letter (CRL) to Corcept for the NDA of relacorilant for the treatment of hypertension secondary to hypercortisolism While the US FDA acknowledged that the pivotal P-III (GRACE) study met its 1EP and that data from the GRADIENT study provided supportive evidence, the Agency concluded that additional…

ByDipanshu DixitJanuary 2, 2026

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Corcept Therapeutics Reports the EMA’s MAA Submission of Relacorilant to Treat Platinum-Resistant Ovarian Cancer

Shots: The EMA has received MAA of relacorilant for the treatment of Pt-resistant ovarian cancer MAA was supported by P-III (ROSELLA) & P-II trials, where relacorilant + nab-paclitaxel demonstrated improved PFS & OS compared to nab-paclitaxel monotx., with no need for biomarker selection & showed favorable safety Relacorilant (PO) is a GR antagonist that is…

ByRidhi RastogiOctober 15, 2025

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Corcept Therapeutics Reports the US FDA’s NDA Acceptance of Relacorilant to Treat Platinum-Resistant Ovarian Cancer

Shots: The US FDA has accepted NDA of relacorilant for the treatment of Pt-resistant ovarian cancer (PDUFA: Jul 11, 2026) NDA was supported by P-III (ROSELLA) & P-II trials, where relacorilant + nab-paclitaxel demonstrated improved PFS & OS compared to nab-paclitaxel monotx., with no need for biomarker selection & favorable safety Additionally, relacorilant (GR antagonist)…

ByRidhi RastogiSeptember 11, 2025

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Corcept Therapeutics Reports NDA Submission of Relacorilant to the US FDA for Treating Hypercortisolism

Shots: Corcept has submitted NDA of relacorilant to the US FDA for the treatment of endogenous hypercortisolism (Cushing’s syndrome) Submission was based on pivotal GRACE study, confirmatory P-III (GRADIENT) & long-term extension trials plus P-II hypercortisolism trial. Relacorilant showed improved symptoms without adrenal insufficiency, hypokalemia, QT prolongation, or progesterone receptor-related AEs (endometrial thickening or…

ByDipanshu DixitJanuary 1, 2025

Corcept Therapeutics Reports the US FDA Approval of Lifyorli (Relacorilant) to Treat Platinum-Resistant Ovarian Cancer

Corcept Therapeutics Reports P-III (ROSELLA) Trial Data on Relacorilant for Platinum-Resistant Ovarian Cancer (PROC)

Corcept Receives US FDA Complete Response Letter for Relacorilant in Hypercortisolism

Corcept Therapeutics Reports the EMA’s MAA Submission of Relacorilant to Treat Platinum-Resistant Ovarian Cancer

Corcept Therapeutics Reports the US FDA’s NDA Acceptance of Relacorilant to Treat Platinum-Resistant Ovarian Cancer

Corcept Therapeutics Reports NDA Submission of Relacorilant to the US FDA for Treating Hypercortisolism

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