Corcept Therapeutics received FDA approval on March 25 2026 for its selective glucocorticoid receptor antagonist Lifyorli™ (relacorilant) in combination with nab‑paclitaxel to treat adults with platinum‑resistant ovarian cancer. The approval marks the company’s first oncology indication and opens a new revenue stream in a market that has limited treatment options.
The pivotal ROSELLA trial, which formed the basis for the approval, showed a 30 % reduction in the risk of disease progression and a 35 % reduction in the risk of death. Median progression‑free survival was 6.5 months for the combination versus 5.5 months for nab‑paclitaxel alone, while median overall survival was 16 months versus 11.9 months. Relacorilant is administered orally at 150 mg once daily for three consecutive days around each 80 mg/m² intravenous nab‑paclitaxel infusion on days 1, 8, and 15 of a 28‑day cycle. Common adverse reactions include decreased hemoglobin and neutrophils, fatigue, nausea, diarrhea, decreased platelets, rash, and decreased appetite.
The FDA’s orphan drug designation for relacorilant in ovarian cancer, combined with an estimated 20,000 U.S. patients with platinum‑resistant disease, positions the product to capture a meaningful share of a niche market. The approval also validates Corcept’s cortisol‑modulation strategy and could accelerate development of relacorilant in other gynecologic and solid‑tumor indications.
Corcept’s chief executive officer, Joseph K. Belanoff, said the approval “is a privilege to bring forward a new treatment for patients who historically have had few options. We have worked for years to demonstrate the potential of cortisol modulation in oncology, and today’s approval is an important first step, but there is much more to explore with this new mode of treatment.”
The approval follows Corcept’s Q4 2025 earnings, where the company reported $761.4 million in revenue and $99.7 million in net income. The oncology milestone is expected to strengthen future earnings growth and diversify the company’s portfolio beyond its established endocrinology products.
Investors reacted positively to the approval, reflecting confidence in Corcept’s oncology platform and the potential for a new revenue stream in a market with unmet needs.
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