Corcept Therapeutics Incorporated (NASDAQ:CORT) stock is trading higher on Thursday, with a session volume of 3.06 million.
The company’s ROSELLA Phase 3 trial of relacorilant plus nab-paclitaxel to treat patients with platinum-resistant ovarian cancer met its overall survival (OS) primary endpoint.
Data
In ROSELLA, patients treated with relacorilant in addition to nab-paclitaxel chemotherapy experienced a 35% reduction in the risk of death compared to patients treated with nab-paclitaxel alone (hazard ratio: 0.65; p-value: 0.0004).
The median OS for patients receiving relacorilant was 16.0 months, compared to 11.9 months for patients receiving nab-paclitaxel alone, a difference of 4.1 months.
Relacorilant in combination with nab-paclitaxel was well-tolerated, consistent with its known safety profile.
The type, frequency, and severity of adverse events in the combination arm were comparable to those in the nab-paclitaxel monotherapy arm. Relacorilant conferred its benefit without increasing the safety burden of the patients who received it.
Corcept previously announced that ROSELLA also met its primary endpoint of improved progression-free survival.
Patients who received relacorilant in addition to nab-paclitaxel experienced a 30% reduction in the risk of disease progression (hazard ratio: 0.70; p-value: 0.008).
Background
In December 2025, the U.S. Food and Drug Administration (FDA) on Wednesday issued a Complete Response Letter (CRL) regarding the New Drug Application (NDA) for relacorilant for hypertension secondary to hypercortisolism.
While the FDA acknowledged that Corcept's pivotal GRACE trial met its primary endpoint and that data from the company's GRADIENT trial provided confirmatory evidence, the FDA concluded it could not arrive at a favorable benefit-risk assessment for relacorilant without Corcept providing additional evidence of effectiveness.
CORT Price Action: Corcept Therapeutics shares were up 19.14% at $43.26 on Thursday, according to Benzinga Pro data.
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