Corcept Therapeutics (NASDAQ:CORT) reported higher revenue in 2025 and issued 2026 guidance as executives used the company’s fourth-quarter earnings call to address two major setbacks: an adverse appellate court decision related to Korlym patents and the FDA’s complete response letter (CRL) for relacorilant in Cushing’s syndrome.
Financial results and 2026 guidance
Chief Financial Officer Atabak Mokari said Corcept generated $761 million in 2025 revenue, up from $675 million in the prior year. The company provided full-year 2026 revenue guidance of $900 million to $1 billion, with management expecting growth to continue.
Patent litigation update: Teva generic Korlym
Chief Business Officer Charlie Robb said the Federal Circuit Court of Appeals ruled against Corcept in its effort to stop Teva Pharmaceuticals from marketing a generic version of Korlym. Robb said Corcept believes the court “made a mistake” and emphasized that patents asserted by the company cover label instructions for administering Korlym safely with other drugs many Cushing’s patients require, including commonly prescribed antifungal and antiviral medications.
Robb said Corcept plans to appeal the decision.
Relacorilant in Cushing’s: company surprised by FDA CRL, meeting set for April
Robb also addressed the FDA’s decision not to approve relacorilant for Cushing’s syndrome, saying the company was surprised given its view of the clinical record and FDA precedent. He noted that the pivotal GRACE trial met its primary endpoint with a p-value of 0.02, and that Corcept’s confirmatory evidence included patients in the double-blind, placebo-controlled GRADIENT trial whom the FDA had identified as particularly important prior to unblinding.
Robb argued the GRACE primary endpoint—improvement in hypertension secondary to Cushing’s syndrome—addresses a serious unmet need, pointing to cardiometabolic complications as the leading cause of death for these patients. He added that most hypertensive patients in GRACE were already taking blood pressure medications, including a portion taking three or more.
On safety, Robb said relacorilant’s profile avoids certain adverse events and off-target effects associated with currently approved treatments, including QT interval prolongation, adrenal insufficiency, hypokalemia, endometrial thickening, irregular vaginal bleeding, and termination of pregnancy. He said liver enzyme elevations cited in the CRL could be managed through label instructions and post-marketing surveillance.
During Q&A, management reiterated that it viewed the filing as meeting approval standards and said there was “daylight” between the agency’s view and Corcept’s. Robb said the company intends to meet with the FDA in April to understand the agency’s thinking and determine next steps. He outlined possible outcomes ranging from resubmission of the NDA (potentially with additional analyses), to a formal appeal to the FDA’s Office of New Drugs, to conducting a new study.
Commercial update: 2025 demand surge, pharmacy transition disrupts late-year performance
Sean Maduck, president of Corcept’s Endocrinology Division, said the company’s Cushing’s business saw a “surge in demand” in 2025, including record new prescriptions and a record number of first-time prescribers. He said Corcept delivered 37% more tablets than in 2024 and saw a 61% increase in new prescriptions, attributing the gap to capacity constraints at its pharmacy vendor.
Maduck said Corcept began transitioning to a new specialty pharmacy in October with greater capacity, but the transfer of prescriptions and medical files disrupted the business in November, December, and January. He said those headwinds have subsided, the new pharmacy received a final batch of patient files earlier in the month, and the company was on track to set a monthly record for new patient starts in February.
Management also discussed the authorized generic (AG) dynamics for Korlym. In Q&A, Maduck said the AG’s net price is about a 30% discount to Korlym’s wholesale acquisition cost (WAC). He said volume shifted toward the AG in 2025 and ended the year at about 75%, and that the business was running at about 78% AG in 2026, with expectations that the mix may increase slightly but has “essentially stabilized.” He added that potential pricing pressures and discounting were built into expectations for 2026.
Mokari said that almost all of the company’s 2026 guidance range is expected to come from the Cushing’s syndrome business, with only a small portion tied to oncology given anticipated launch timing.
Pipeline highlights: ROSELLA results, upcoming readouts, and other programs
Chief Executive Officer Joe Belanoff highlighted multiple development programs, with a major focus on oncology. He said Corcept’s Phase III ROSELLA trial in platinum-resistant ovarian cancer met both dual primary endpoints, with patients receiving relacorilant plus nab-paclitaxel showing longer progression-free and overall survival than those receiving nab-paclitaxel alone. Belanoff reported a hazard ratio of 0.65 for overall survival, corresponding to a 35% reduction in risk of death with a p-value of 0.0004, and said median overall survival was 4.1 months longer in the relacorilant arm. He added that at the 75th percentile of the survival curve, patients receiving relacorilant lived eight months longer than those on monotherapy.
Corcept said it plans to present full ROSELLA results at the Society of Gynecologic Oncology meeting in April and publish them later in the year. In Q&A, Chief Development Officer Bill Guyer said the SGO presentation is expected to include the full Kaplan-Meier curves and full safety datasets, and that the final survival analysis showed a safety profile similar to what the company reported about a year earlier. Guyer also said Corcept was not seeing concerning ALT elevations in ROSELLA and noted that nab-paclitaxel itself can raise liver enzymes; he said the combination arm showed fewer ALT rises than the nab-paclitaxel-alone arm.
Belanoff said the company’s FDA PDUFA date is July 11 for relacorilant in oncology. He also outlined additional development work in other solid tumors and combinations, including studies intended to be guideline-enabling and inform future decisions, with results expected by the end of next year. The company also described early-stage work with nenocorilant in combination with nivolumab and an investigator-led study of relacorilant plus enzalutamide in early-stage prostate cancer.
Outside oncology, Belanoff said Corcept’s Phase IIb MONARCH study of miricorilant in metabolic dysfunction-associated steatohepatitis (MASH) is fully enrolled and is expected to produce results by year-end, with a move to Phase III if positive. He also discussed the Phase II DASLES trial of dazucorilant in ALS, stating that patients receiving 300 mg for one year showed an 84% reduction in risk of death versus placebo with a p-value of 0.0009. He said the company started a small dose-titration study aimed at improving gastrointestinal tolerability and plans to incorporate those learnings into the design of a pivotal trial expected to start later in the year.
Belanoff also pointed to upcoming data from the MOMENTUM trial, a 1,000-patient study examining hypercortisolism prevalence in resistant hypertension, with results to be presented next month at the American College of Cardiology meeting.
About Corcept Therapeutics (NASDAQ:CORT)
Corcept Therapeutics is a clinical-stage biopharmaceutical company focused on discovering and developing drugs that modulate the effects of cortisol, a hormone implicated in a range of severe metabolic, oncologic and psychiatric disorders. The company’s scientific platform centers on selectively targeting the glucocorticoid receptor to counteract the harmful consequences of excess cortisol, a strategy designed to address diseases with significant unmet medical needs.
The company’s flagship marketed product, Korlym (mifepristone), is approved in the United States for the treatment of hyperglycemia secondary to Cushing’s syndrome in patients who have type 2 diabetes or glucose intolerance and are not candidates for surgery.
