Detailed Narrative
Cushing's Syndrome Business Momentum
The Cushing's syndrome business continues to experience strong demand, with Q2 FY26 seeing record numbers of new prescriptions, first-time prescribers, and patients on medication. This growth is attributed to increasing physician awareness of hypercortisolism's prevalence, particularly in patients with difficult-to-treat diabetes (24% prevalence) and resistant hypertension (27% prevalence), as highlighted by the CATALYST and MOMENTUM trials. The company expects this trend to continue, projecting annual revenue for the Cushing's syndrome business to reach at least $2 billion by the end of the decade, and $3 billion to $5 billion by 2030 with the addition of relacorilant.
Lifyorli Launch Success in Oncology
Lifyorli's launch for platinum-resistant ovarian cancer has been exceptionally strong, generating $47.6 million in revenue in its first quarter of availability. Over 1,300 patients have initiated treatment, and more than 1,000 unique prescribers have written prescriptions. The drug's compelling clinical profile, including strong efficacy data (35% reduction in risk of death in ROSELLA trial), manageable safety, oral administration, and no biomarker requirement, has driven rapid adoption. Payer coverage is excellent, with NCCN guidelines listing Lifyorli as a preferred regimen and over 70% of combined Medicare, Medicaid, and commercial lives having formal coverage policies.
Relacorilant Regulatory Update
The New Drug Application (NDA) for relacorilant in Cushing's syndrome, based on positive Phase III GRACE and GRADIENT trials, was resubmitted on June 17, 2026, following a Complete Response Letter (CRL) at the end of last year. The FDA accepted the resubmission and assigned a PDUFA date of December 17, 2026. Management expressed disappointment with the initial CRL but is focused on making relacorilant available as soon as possible to address the unmet needs in Cushing's syndrome.
Expanding Oncology Pipeline
Corcept is actively exploring the broad potential of GR antagonism in oncology beyond platinum-resistant ovarian cancer. Several trials are underway, including BELLA (relacorilant in platinum-resistant/sensitive ovarian cancer and endometrial cancer), STELLA (cervical cancer), and TRIDENT (first-line pancreatic cancer), with results expected by the end of 2027. These studies aim to provide NCCN-guideline enabling data and could increase the number of patients relacorilant may help by fivefold. Additionally, the SYNERGY Phase Ib study is evaluating nenocorilant in combination with nivolumab for various solid tumors, with results anticipated by the end of 2027.
Metabolic and Neurological Pipeline Progress
The company is advancing miricorilant for Metabolic Dysfunction-Associated Steatohepatitis (MASH), with the Phase IIb MONARCH study having completed enrollment and data expected later this year. Positive results would support progression to Phase III. For Amyotrophic Lateral Sclerosis (ALS), the Phase II DAZALS trial for dazucorilant showed an 84% reduction in risk of death at one year and 87% at two years. A dose titration study is ongoing to improve gastrointestinal tolerability, informing the design of a pivotal trial planned for early next year.