Category CORT

In one of the most striking turnarounds in biotech over the past three months, Corcept Therapeutics has moved from potential extinction to validation of a core thesis. On March 25, 2026, the U.S. FDA approved Lifyorli™ (relacorilant) in combination with nab-paclitaxel for adults with platinum-resistant ovarian, fallopian tube, or primary peritoneal cancer who have received one to three prior systemic regimens. This is Corcept's second commercially approved product and, more importantly, the first FDA-approved selective glucocorticoid receptor antagonist (SGRA) in oncology.

This approval comes exactly 12 weeks after the December 31, 2025 Complete Response Letter (CRL) that sent CORT plummeting 50% in a single day and raised serious questions about whether Corcept's relacorilant program was a scientific and commercial mirage. It also arrives 5 weeks after the Federal Circuit affirmed that Corcept's key Korlym patents do not prevent Teva's generic, further pressuring the company's legacy cash engine.

The stock opened up +40% on the approval news, erasing much of the CRL damage. But the narrative is now far more complex: Cushing's syndrome access to relacorilant has been effectively closed off until Corcept runs a new trial (likely 3-5 years away), while ovarian cancer and emerging programs in MASH, ALS, and other indications are now in focus. The balance sheet remains strong (>$500M cash, profitable), but investor sentiment has fractured into those betting on Lifyorli's oncology success and those worried about execution, dilution, and the class action lawsuits now pending against management.

CRL in one paragraph:
The FDA acknowledged that one of Corcept’s Phase 3 trials in Cushing was successful, but another failed its primary endpoint. Given this mixed picture, the agency said it could not reach a favorable benefit-risk assessment without additional evidence of effectiveness and therefore rejected the NDA via CRL. No insurmountable safety issues were cited; the focus is efficacy and consistency.