CORT Corcept

Corcept: 2026 ADA/EASD Consensus Recommends Hypercortisolism Screening in Difficult-to-Control T2D, Cites CATALYST

The 2026 ADA/EASD consensus report on type 2 diabetes management now recommends screening adults for hypercortisolism when diabetes is difficult to control despite multiple glucose-lowering agents. The report cites Corcept's CATALYST study showing mifepristone (Korlym) substantially reduced HbA1c in these patients and may benefit hyperglycemia management.

relacorilant · NCT03604198 registry update

countries: {'total_sites': 44, 'us_sites': 25} → {'total_sites': 48, 'us_sites': 25}

relacorilant · NCT05257408 registry update

primary_completion: 2025-03-24 → 2025-03-31; completion: 2026-03 → 2026-12; primary_outcomes: ['Progression-free Survival as Assessed by BICR', 'Overall survival'] → ['Progression-free Survival (PFS) as Assessed by Blinded Independent Central Review (BICR)', 'Overall Survival']; countries: {'total_sites': 117, 'us_sites': 44} → {'total_sites': 116, 'us_sites': 44}

Corcept Receives Positive CHMP Opinion for Relacorilant + Nab-Paclitaxel in Platinum-Resistant Ovarian Cancer

The EMA's CHMP issued a positive opinion recommending EU marketing authorization for relacorilant combined with nab-paclitaxel for platinum-resistant ovarian cancer, based on Phase 2 and Phase 3 ROSELLA trial data showing improved PFS and OS versus nab-paclitaxel alone. The European Commission will review and issue a final approval decision in Q4 2026. This advances the EU regulatory path for the asset, which is already approved and marketed as Lifyorli in the US for the same indication.

Corcept resubmits relacorilant NDA for Cushing’s syndrome; PDUFA Dec 17, 2026

Corcept resubmitted its NDA for relacorilant in Cushing’s syndrome in June 2026. The FDA has assigned a PDUFA target action date of December 17, 2026, providing a firm regulatory decision timeline for the asset.

Corcept resubmits NDA for relacorilant in Cushing’s syndrome

Corcept has resubmitted its NDA for relacorilant in Cushing’s syndrome after addressing FDA-requested additional analyses. The resubmission triggers a six-month review clock. The filing is supported by the GRACE and GRADIENT Phase 3 trials plus long-term extension data.

Corcept to resubmit relacorilant NDA for Cushing’s syndrome

Corcept will resubmit its NDA for relacorilant after addressing FDA’s additional data analyses. The FDA has indicated a six-month PDUFA clock will start upon resubmission, expected in the coming weeks.

Corcept: FDA approves Lifyorli (relacorilant) for platinum-resistant ovarian cancer

FDA approved Lifyorli (relacorilant) plus nab-paclitaxel in March 2026 for platinum-resistant ovarian cancer, more than three months ahead of its PDUFA date. The approval converts the asset from a single-product revenue base to a two-product franchise and triggers immediate NCCN Guidelines inclusion as a preferred regimen. Corcept now guides 2026 revenue of $950–$1,050 million, reflecting the new oncology indication.

Corcept to present ROSELLA Phase 3 data at ASCO 2026

Corcept will present new subgroup analyses from the pivotal Phase 3 ROSELLA trial of relacorilant plus nab-paclitaxel in platinum-resistant ovarian cancer at the ASCO 2026 Annual Meeting on May 29, 2026. The presentation will focus on overall survival subgroup analyses for prior taxane use. The drug was approved by the FDA in March 2026 and is already included in NCCN Guidelines as a preferred regimen.

Corcept Therapeutics Inc. · FDA approves Lifyorli (relacorilant)

FDA lists Lifyorli (relacorilant) as novel drug approval #9 of 2026 on 2026-03-25: To treat platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer after one to three prior systemic treatment regimens, at least one of which included bevacizumab

Corcept: relacorilant NDA in PROC has July 11, 2026 PDUFA

The FDA has accepted the NDA for relacorilant plus nab-paclitaxel in platinum-resistant ovarian cancer and set a PDUFA target action date of July 11, 2026. The application is supported by the final overall survival results from the ROSELLA Phase 3 trial. A parallel MAA is under review by the EMA with an expected approval decision by the end of 2026.

Corcept Therapeutics · complete response letter (NDA 219398)

FDA issued a complete response letter for NDA 219398 dated 2026-01-28.

Corcept: ROSELLA Phase 3 meets OS endpoint for relacorilant in platinum-resistant ovarian cancer

ROSELLA Phase 3 trial met its overall-survival primary endpoint, showing a 35 % reduction in risk of death (HR 0.65, p=0.0004) and a 4.1-month median-OS gain (16.0 vs 11.9 months) with relacorilant plus nab-paclitaxel versus nab-paclitaxel alone. The NDA for relacorilant in platinum-resistant ovarian cancer remains under FDA review with a PDUFA target action date of July 11, 2026; an MAA is also under EMA review.

Corcept receives CRL for relacorilant in hypercortisolism

FDA issued a Complete Response Letter for the NDA of relacorilant in hypertension secondary to hypercortisolism. The Agency acknowledged the GRACE trial met its primary endpoint and GRADIENT provided confirmatory evidence, but concluded additional evidence of effectiveness is required for a favorable benefit-risk assessment. Corcept plans to meet with the FDA as soon as possible to determine next steps.

Corcept: relacorilant NDA PDUFA set for Dec 30, 2025

The press release states that the NDA for relacorilant in hypercortisolism has a PDUFA date of December 30, 2025. This sets the regulatory deadline for FDA action on the application. The company states it believes the deadline will be met.