relacorilant (CORT125134) / Corcept Therap - LARVOL DELTA

ROSELLA: A phase 3 study of relacorilant in combination with nab-paclitaxel versus nab-paclitaxel monotherapy in patients with platinum-resistant ovarian cancer (GOG-3073, ENGOT-ov72). (ASCO 2025) - P3 | "Key eligibility criteria included 1–3 prior lines of anticancer therapy and prior bevacizumab. Relacorilant + nab-paclitaxel is the first treatment regimen to demonstrate a PFS and OS benefit in patients with PROC compared to a weekly taxane, the most efficacious comparator. These positive efficacy data and a favorable safety profile position relacorilant + nab-paclitaxel as a new standard for patients with PROC, without the need for biomarker selection."

Clinical • Combination therapy • Late-breaking abstract • Monotherapy • P3 data • Platinum resistant • Anemia • Neutropenia • Oncology • Ovarian Cancer • Solid Tumor

Gynecologic cancers in 2025: a year in review. (PubMed, Int J Gynecol Cancer) - "In advanced ovarian cancer, TRUST re-examined surgical timing, supporting primary cytoreduction in selected resectable patients, whereas ICON8B suggested that weekly paclitaxel with carboplatin and bevacizumab may improve outcomes in high-risk disease. Platinum-resistant ovarian cancer saw the most disruptive progress: mirvetuximab soravtansine validated folate receptor-α as a therapeutic target, with overall survival benefit in high-expressing tumors; trastuzumab deruxtecan expanded actionable HER2 disease, with greatest activity in tumors rated 3+ by immunohistochemistry; and combination strategies, including relacorilant plus nab-paclitaxel and pembrolizumab plus weekly paclitaxel ± bevacizumab, delivered clinically meaningful survival signals, underscoring the need for harmonized biomarker strategies and proactive toxicity mitigation...In cervical cancer, pembrolizumab added to definitive chemoradiotherapy set a new benchmark in locally advanced disease, and..."

IO biomarker • Journal • Review • Cervical Cancer • Endometrial Cancer • Gynecologic Cancers • Oncology • Ovarian Cancer • Solid Tumor • FOLR1 • HER-2

Reported psychological stress and glucocorticoids in endometrial cancer patients - IPSECC feasibility study (ESGO 2026) - "The therapeutic potential of GR modulation by Relacorilant, a selective GR modulator, as shown in breast and ovarian cancer, opens the case for GR modulation in patients with EC.Methodology This is a non-randomised feasibility study to examine correlation of stress measures (questionnaires, hair, saliva, blood, tissue) in EC patients with disease behaviour (e.g., tumour growth, molecular markers, clinical outcomes)...Analysis of stress measures, questionnaires (i.e., State-Trait Anxiety Inventory, Perceived Stress Scale, Functional Assessment of Cancer Therapy for Patients with Endometrial Cancer), and EC disease behaviour will include molecular techniques and assays, correlation of results, as well as patient-derived organoids. Conclusion Final results are expected in Spring 2027."

Clinical • Endometrial Cancer • Oncology • Ovarian Cancer • Solid Tumor

Evaluation of relacorilant as a glucocorticoid receptor modulator for maintenance therapy following standard first-line treatment in ovarian cancer organoid models (ESGO 2026) - "Introduction/Background Ovarian cancer treatment typically involves cytoreductive surgery followed by carboplatin–paclitaxel chemotherapy, and is often accompanied by chronically elevated psychological stress. Relacorilant counteracts this effect, restoring growth control in patient-derived organoids. These results highlight GR modulation as a promising strategy to prevent relapse and maintain remission in ovarian cancer."

Clinical • Oncology • Ovarian Cancer • Solid Tumor

Relacorilant restores PD-L1 expression and a pro-inflammatory tumour microenvironment in glucocorticoid-treated ovarian cancer models (ESGO 2026) - "Although relacorilant restores PD-L1 expression it also promotes a pro-inflammatory cytokine milieu, suggesting that GR modulation can enhance tumour immunogenicity. These findings support the rationale for combining GR modulators with PD-L1 inhibitors in ovarian cancer therapy."

IO biomarker • Preclinical • Tumor microenvironment • Oncology • Ovarian Cancer • Solid Tumor • IFNG • NR3C1 • PD-L1 • PD-L2 • TNFA

Relacorilant + nab-paclitaxel vs nab-paclitaxel in platinum-resistant ovarian cancer: pharmacokinetics and pharmacokinetic/pharmacodynamic exposure-response (ESGO 2026) - P2, P3 | "No relationships were identified between relacorilant or nab-paclitaxel exposures and other AEs, including peripheral neuropathy, neutropenia, skin and subcutaneous tissue disorders, and gastrointestinal disorders.Conclusion In Study-552, similar nab-paclitaxel exposures were observed across arms and no relationships were identified between PFS and relacorilant or nab-paclitaxel PK, indicating the clinical benefit is attributed to addition of relacorilant, not increased nab-paclitaxel exposures. No relationships were identified between relacorilant or nab-paclitaxel exposures and AEs, except for an association between relacorilant AUC and anemia."

PK/PD data • Platinum resistant • Oncology • Ovarian Cancer • Solid Tumor

ROSELLA (GOG3073, engotov72, APGOT-OV10): a phase 3 study of relacorilant + nab-paclitaxel in patients with platinum-resistant ovarian cancer (ESGO 2026) - No abstract available

Clinical • P3 data • Platinum resistant • Oncology • Ovarian Cancer • Solid Tumor

PHASE 3 ROSELLA (GOG-3073, ENGOT-OV72) TRIAL OF RELACORILANT + NAB-PACLITAXEL VS NAB-PACLITAXEL IN PLATINUM-RESISTANT OVARIAN CANCER: PRIMARY RESULTS AND OUTCOMES IN OLDER PATIENTS (IGCS 2025) - "The addition of relacorilant to nab-paclitaxel showed a statistically significant improvement in PFS by BICR and a clinically meaningful benefit in OS at the interim analysis (Table). Patients aged ≥65 were heavily pretreated, had advanced disease, and were similarly distributed between treatment arms (38.3% vs 41.5%). The addition of relacorilant was associated with a 39% reduction in the risk of progression in this subgroup (PFS by BICR: HR 0.61 [95% CI 0.40-0.94] P=0.0247)."

Clinical • Late-breaking abstract • P3 data • Platinum resistant • Oncology • Ovarian Cancer • Solid Tumor

High-risk localized prostate cancer treated with neoadjuvant LHRH agonist/antagonist and enzalutamide plus the glucocorticoid receptor antagonist relacorilant versus placebo. (ASCO-GU 2026) - P2 | "Clinical Trial Registry Number: NCT05726292. The full, final text of this abstract will be available on Feb 23 at 05:00 PM EST."

Clinical • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

Phase III results of relacorilant + nab-paclitaxel vs nab-paclitaxel in platinum-resistant ovarian cancer (PROC) (ROSELLA, GOG-3073, ENGOT-ov72): Secondary endpoints (ESMO-GC 2025) - P3 | "Key eligibility criteria included 1–3 prior lines of anticancer therapy and prior bevacizumab. Editorial acknowledgement Medical writing support was provided by Farida Khan, PhD, CMPP, an employee of Corcept Therapeutics Incorporated. Legal entity responsible for the study Corcept Therapeutics."

P3 data • Platinum resistant • Gynecologic Cancers • Oncology • Ovarian Cancer • Solid Tumor

The latest adverse development for Corcept Therapeutics…concerning its proposed treatment of patients with hypercortisolism (also known as Cushing’s syndrome) – relacorilant – came on January 30, 2026 when Reuters reported that the FDA 'warned the company ‘on several occasions’ not to submit its drug application' (GlobeNewswire) - "This news sent the price of Corcept shares tumbling $7.81 (-17%) during trading that day. The move lower comes after investors saw the price of their shares crater 50% on December 31, 2025 after the company announced its receipt of a complete response letter ('CRL') from the FDA for the therapy."

FDA event • Stock price • Cushing’s Disease

Relacorilant With Nab-Paclitaxel and Gemcitabine in Patients With Metastatic Pancreatic Adenocarcinoma (clinicaltrials.gov) - P2 | N=60 | Recruiting | Sponsor: Corcept Therapeutics | Not yet recruiting ➔ Recruiting

Enrollment open • Oncology • Pancreatic Adenocarcinoma • Pancreatic Cancer • CA 19-9

Relacorilant and nab-paclitaxel in patients with platinum-resistant ovarian cancer (ROSELLA): an open-label, randomised, controlled, phase 3 trial. (PubMed, Lancet) - P3 | "The addition of relacorilant to nab-paclitaxel prolonged progression-free survival and interim results also showed an improvement in overall survival. Together, the results position the combination of relacorilant and nab-paclitaxel as a potential new standard treatment for patients with platinum-resistant ovarian cancer."

Journal • P3 data • Platinum resistant • Carcinosarcoma • Fallopian Tube Cancer • Oncology • Ovarian Cancer • Sarcoma • Solid Tumor

ROSELLA (GOG3073, ENGOTov72, APGOT-OV10): Relacorilant + nab-paclitaxel in the subgroup of patients with platinum-resistant ovarian cancer (PROC) previously exposed to a PARP inhibitor (ESMO 2025) - P3 | "Table: LBA45 Efficacy summary ITT Prior PARPi Relacorilant + nab-paclitaxel N=188 Nab-paclitaxel N=193 Relacorilant + nab-paclitaxel n=114 Nab-paclitaxel n=120 PFS (BICR) Events , n (%) 113 (60.1) 121 (62.7) 66 (57.9) 72 (60.0) Median , months 6.54 5.52 7.36 4.63 HR (95% CI) 0.70 (0.54-0.91) 0.60 (0.42-0.85) P-value (Log-rank) P=0.0076 Nominal P=0.0035 OS (Interim) Events , n (%) 82 (43.6) 110 (57.0) 51 (44.7) 65 (54.2) Median , months 15.97 11.50 15.61 12.58 HR (95% CI) 0.69 (0.52-0.92) 0.77 (0.53-1.13) P-value (Log-rank) P=0.0121 Nominal P=0.1834 Conclusions In patients with PROC previously exposed to a PARPi, relacorilant + nab-paclitaxel showed clinically meaningful improvements in PFS and OS. The median PFS of 7.36 months compares favorably to the median time from first to second subsequent therapy in patients who progressed while receiving a PARPi in the PAOLA1 trial (Ann Oncol 2025; 36:185) and supports further exploration of relacorilant to improve outcomes..."

Clinical • Late-breaking abstract • Platinum resistant • Gynecologic Cancers • Oncology • Ovarian Cancer

Overall Survival Primary Endpoint Met in Corcept’s Pivotal Phase 3 ROSELLA Trial of Relacorilant in Patients with Platinum-Resistant Ovarian Cancer (Businesswire) - "In ROSELLA, patients treated with relacorilant in addition to nab-paclitaxel chemotherapy experienced a 35 percent reduction in the risk of death compared to patients treated with nab-paclitaxel alone (hazard ratio: 0.65; p-value: 0.0004). The median OS for patients receiving relacorilant was 16.0 months, compared to 11.9 months for patients receiving nab-paclitaxel alone, a difference of 4.1 months. Relacorilant in combination with nab-paclitaxel was well-tolerated, consistent with its known safety profile."

P3 data • Platinum resistant • Ovarian Cancer

Overall Survival Primary Endpoint Met in Corcept’s Pivotal Phase 3 ROSELLA Trial of Relacorilant in Patients with Platinum-Resistant Ovarian Cancer Share (Businesswire) - "In ROSELLA, patients treated with relacorilant in addition to nab-paclitaxel chemotherapy experienced a 35 percent reduction in the risk of death compared to patients treated with nab-paclitaxel alone (hazard ratio: 0.65; p-value: 0.0004). The median OS for patients receiving relacorilant was 16.0 months, compared to 11.9 months for patients receiving nab-paclitaxel alone, a difference of 4.1 months...Complete results from ROSELLA will be presented at an upcoming medical conference.....The FDA has assigned a Prescription Drug User Fee Act (PDUFA) date of July 11, 2026 for relacorilant as a treatment for patients with platinum-resistant ovarian cancer."

P3 data • PDUFA • Platinum resistant • Ovarian Cancer

Overall survival data from a 3-arm, randomized, open-label, phase 2 study of relacorilant, a selective glucocorticoid receptor modulator, combined with nab-paclitaxel in patients with recurrent platinum-resistant ovarian cancer. (ASCO 2022) - P2, P3 | "In addition to the improved PFS and DOR observed at the primary analysis, the OS analysis confirmed the survival benefit of intermittent RELA + NP compared to NP only, particularly in patients who were not primary platinum refractory. A phase 3 trial evaluating intermittent RELA + NP vs investigator’s choice of chemotherapy in patients without primary platinum-refractory disease is ongoing (NCT05257408)."

Clinical • Late-breaking abstract • P2 data • Fallopian Tube Cancer • Oncology • Ovarian Cancer • Sarcoma • Solid Tumor • RELA

BELLA: a phase 2 study of relacorilant plus nab-paclitaxel +/- bevacizumab in patients with gynecologic cancers (SGO 2026) - No abstract available

Clinical • P2 data • Gynecologic Cancers • Oncology

Relacorilant plus nab-paclitaxel demonstrates a progression-free survival benefit in ovarian cancer independent of tumor glucocorticoid receptor (GR) expression levels (SGO 2026) - No abstract available

Biomarker • Oncology • Ovarian Cancer • Solid Tumor • NR3C1

Corcept Therapeutics…announced that the U.S. Food and Drug Administration (FDA or the Agency) has issued a Complete Response Letter (CRL) regarding the New Drug Application (NDA) for relacorilant as a treatment for patients with hypertension secondary to hypercortisolism (Businesswire) - "While the FDA acknowledged that Corcept’s pivotal GRACE trial met its primary endpoint and that data from the company’s GRADIENT trial provided confirmatory evidence, the Agency concluded it could not arrive at a favorable benefit-risk assessment for relacorilant without Corcept providing additional evidence of effectiveness....'We will meet with the FDA as soon as possible to discuss the best path forward'."

CRL • Cushing’s Disease

Relacorilant With Nab-Paclitaxel and Gemcitabine in Patients With Metastatic Pancreatic Adenocarcinoma (clinicaltrials.gov) - P2 | N=60 | Not yet recruiting | Sponsor: Corcept Therapeutics

New P2 trial • Oncology • Pancreatic Adenocarcinoma • Pancreatic Cancer • CA 19-9

Clinical Development (Businesswire) - "(i) Cervical cancer - Phase 2 trial of relacorilant plus nab-paclitaxel in 50 patients with cervical cancer (received one or two prior lines of therapy) to begin in coming weeks, conducted in collaboration with ARCAGY-GINECO, an academic clinical research group specializing in gynecologic cancers; (ii) Pancreatic cancer - Phase 2 trial of relacorilant plus nab-paclitaxel and gemcitabine as first-line therapy in 50 patients with pancreatic cancer to begin in coming weeks."

New P2 trial • Cervical Cancer • Pancreatic Cancer

Marketing Authorization Application (MAA) (Businesswire) - "European Medicines Agency reviewing MAA for relacorilant plus nab-paclitaxel to treat patients with platinum-resistant ovarian cancer – Approval expected by the end of next year."

EMA approval • Platinum resistant • Ovarian Cancer

Relacorilant in Combination with Chemotherapy (Businesswire) - "(i) BELLA Part A - Enrollment nearly complete in Phase 2 trial of relacorilant plus nab-paclitaxel and bevacizumab in 90 patients with platinum-resistant ovarian cancer – Results expected by the end of next year; (ii) BELLA Part B - Phase 2 trial of relacorilant plus nab-paclitaxel and bevacizumab in 90 patients with platinum-sensitive ovarian cancer whose disease progressed while on a PARP inhibitor to begin in coming weeks; (iii) BELLA Part C - Phase 2 trial of relacorilant plus nab-paclitaxel in 90 patients with endometrial cancer (who have received one or two prior lines of therapy) to begin in coming weeks."

P2 data • Platinum resistant • Platinum sensitive • Trial status • Endometrial Cancer • Ovarian Cancer

ROSELLA…pivotal Phase 3 trial of relacorilant plus nab-paclitaxel in 381 patients with platinum-resistant ovarian cancer (Businesswire) - "Final overall survival results expected by early next year."

P3 data • Platinum resistant • Ovarian Cancer