Corcept Therapeutics reports developments in cortisol modulation therapies for severe endocrinologic, oncologic, metabolic and neurologic disorders. The company markets Korlym for endogenous Cushing’s syndrome and Lifyorli, a relacorilant regimen approved with nab-paclitaxel for certain adults with platinum-resistant ovarian, fallopian tube or primary peritoneal cancer.
Recurring news includes financial results, revenue guidance, clinical data from programs such as ROSELLA, DAZALS and MOMENTUM, FDA-related updates, medical-conference presentations, publications, patent matters and distribution arrangements tied to Korlym, Lifyorli and the company’s selective cortisol modulator pipeline.
Corcept (NASDAQ: CORT) reported that its pivotal Phase 3 ROSELLA trial of relacorilant plus nab-paclitaxel in platinum-resistant ovarian cancer met both dual primary endpoints. The combination reduced the risk of death by 35% (HR 0.65; p=0.0004) and extended median overall survival to 16.0 months vs 11.9 months (difference 4.1 months). ROSELLA also showed a 30% reduction in progression risk (HR 0.70; p=0.008). The regimen was well tolerated with similar adverse event profiles versus nab-paclitaxel alone. The NDA is under FDA review with a PDUFA date of July 11, 2026, and an MAA is under EMA review. ROSELLA enrolled 381 patients randomized 1:1 across multiple regions.
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.
Corcept Therapeutics (NASDAQ: CORT) reported Q3 2025 revenue of $207.6M (vs. $182.5M in Q3 2024) and net income of $19.7M. Cash and investments were $524.2M at Sept 30, 2025. The company adjusted 2025 revenue guidance to $800–$850M citing prior specialty pharmacy capacity constraints and added a new specialty pharmacy on Oct 1.
Key development milestones include a Dec 30, 2025 PDUFA for relacorilant in hypercortisolism, a Jul 11, 2026 PDUFA for relacorilant in platinum-resistant ovarian cancer, ROSELLA meeting its primary endpoint, upcoming BELLA/BELLA parts and new Phase 2/1b oncology and Phase 3 ALS trials.
Corcept Therapeutics (NASDAQ: CORT) will report third quarter 2025 financial results and provide a corporate update on November 4, 2025. The company will host a conference call on that date at 5:00 p.m. Eastern Time (2:00 p.m. Pacific Time).
Participants must register in advance to receive a dial-in number and a unique access PIN; a listen-only webcast will also be available. A replay will be posted on the Investors / Events tab at Corcept.com.
Corcept (NASDAQ: CORT) presented late-breaking Phase 3 ROSELLA data at ESMO 2025 showing relacorilant plus nab-paclitaxel improved outcomes in platinum-resistant ovarian cancer, including patients with prior PARP inhibitor (PARPi) exposure.
Key results: prior PARPi subgroup PFS HR 0.60 (p=0.0035), progressed-on-PARPi subgroup PFS HR 0.56 (p=0.0046) with median PFS 7.36 months. ROSELLA met primary PFS endpoint HR 0.70 (p=0.0076) and interim OS favored the combination HR 0.69 (p=0.0121). Safety in PARPi subgroups was comparable to nab-paclitaxel alone. Corcept also expanded the Phase 2 BELLA trial to three arms; initial BELLA results expected in late 2026.
Corcept (NASDAQ: CORT) submitted a Marketing Authorization Application (MAA) to the European Medicines Agency for relacorilant to treat platinum-resistant ovarian cancer on October 14, 2025.
The submission is based on positive results from the pivotal Phase 3 ROSELLA and Phase 2 trials where relacorilant plus nab-paclitaxel improved progression-free and overall survival versus nab-paclitaxel alone, with no biomarker selection required. Safety in combination was reported as comparable to nab-paclitaxel monotherapy. The U.S. FDA is also reviewing an application, with a PDUFA target action date of July 11, 2026.
Corcept Therapeutics (NASDAQ: CORT) will present new late-breaking data from its pivotal Phase 3 ROSELLA trial at the 2025 ESMO Annual Meeting. The presentation will focus on results of relacorilant plus nab-paclitaxel treatment in platinum-resistant ovarian cancer patients who were previously treated with PARP inhibitors - a group with particularly poor prognosis.
The trial represents a significant international collaboration, involving major oncology research groups including GOG-F, ENGOT, APGOT, LACOG, and ANZGOG. The presentation (LBA45) is scheduled for October 19, 2025, at 10:15 AM CEST during the gynaecological cancers mini oral session.
Corcept Therapeutics (NASDAQ: CORT) announced that the FDA has accepted its New Drug Application (NDA) for relacorilant in treating platinum-resistant ovarian cancer, with a PDUFA date set for July 11, 2026.
The NDA submission is supported by positive results from the Phase 3 ROSELLA and Phase 2 trials, where relacorilant combined with nab-paclitaxel demonstrated improved progression-free and overall survival compared to nab-paclitaxel alone. Notably, the treatment showed favorable safety outcomes, with adverse events comparable to the control group and no biomarker selection requirement.
Corcept Therapeutics (NASDAQ: CORT) reported strong Q2 2025 financial results with revenue of $194.4 million, up from $163.8 million in Q2 2024. The company modified its 2025 revenue guidance to $850-900 million due to specialty pharmacy capacity constraints amid surging demand. Net income was $35.1 million with cash and investments of $515.0 million.
Key developments include two NDAs in progress - one for hypercortisolism and another for platinum-resistant ovarian cancer, with relacorilant's PDUFA date set for December 30, 2025. The ROSELLA trial results were published in The Lancet, while the DAZALS trial showed an 84% reduction in death risk for ALS patients receiving dazucorilant. The company repurchased $115.4 million of common stock during Q2.
Corcept Therapeutics (NASDAQ: CORT) has scheduled its second quarter 2025 financial results announcement and corporate update for July 31, 2025. The company will host a conference call at 5:00 p.m. Eastern Time (2:00 p.m. Pacific Time) on the same day.
Participants must pre-register for the conference call to receive their unique access PIN and dial-in number. A listen-only webcast option will also be available, and a replay of the call will be accessible through the Investors / Events section of Corcept.com.