Regulatory2026-07-29

Relacorilant - (GRACE)

Corcept Therapeutics IncorporatedCORT
Indication
Hypercortisolism (Cushing's Syndrome)
Stage
phase5
Event
Regulatory Decision
Details

July 29, 2026: Corcept Therapeutics Incorporated (NASDAQ: CORT) reported Q2 2026 results and outlined multiple upcoming regulatory and clinical catalysts across relacorilant and other programs. Revenue was $256.1M (+32% YoY), including Korlym/authorized generic $208.6M and first-quarter Lifyorli revenue of $47.6M; 2026 revenue guidance was raised to $1.1–$1.2B.

Relacorilant / Lifyorli (oncology; platinum-resistant ovarian cancer): Lifyorli (relacorilant) plus nab-paclitaxel was FDA-approved in March 2026 and added as a preferred regimen to NCCN Guidelines in April 2026. EMA is reviewing a Marketing Authorization Application for relacorilant plus nab-paclitaxel, with approval expected by end of 2026. ROSELLA Phase 3 met both dual primary endpoints (PFS and OS) and was published in The Lancet (April 2026). BELLA Part A (relacorilant+nab-paclitaxel+bevacizumab; platinum-resistant) enrollment is complete; results are expected by end of 2026. Additional relacorilant studies in platinum-sensitive ovarian, endometrial, cervical (STELLA initiated), and pancreatic cancer (TRIDENT) have results expected by end of 2027; a Phase 2 prostate study (with enzalutamide) continues. Nenocorilant+nivolumab (SYNERGY) Phase 1b continues; results expected end of 2027.

Relacorilant (Cushing’s syndrome): NDA resubmitted in June with a PDUFA date of Dec. 17, 2026; GRACE Phase 3 results were published (Feb 2026), and new CATALYST/MOMENTUM data were presented at ADA (June).

Miricorilant (MASH): MONARCH Phase 2b enrollment complete; results expected by end of 2026.

Dazucorilant (ALS): Phase 3 trial planned to begin early next year; DAZALS exploratory analyses reported reduced risk of death vs placebo (HR 0.16 in year 1; HR 0.13 in year 2).