Relacorilant Achieves Survival Milestone in Platinum-Resistant Ovarian Cancer Treatment

The biotech sector witnessed significant portfolio movement on January 22, when Corcept Therapeutics reported breakthrough clinical data that could reshape treatment paradigms for platinum-resistant ovarian cancer. This cancer indication represents a critical frontier in oncology, where limited treatment options have created substantial unmet medical needs. The company’s investigational drug, relacorilant, demonstrated compelling efficacy when combined with standard chemotherapy in the phase III ROSELLA trial, providing investors and patients alike with renewed optimism about the pipeline expansion beyond the company’s current marketed product.

Clinical Breakthrough: ROSELLA Trial Delivers Positive Overall Survival Data

The ROSELLA study met its primary endpoint by demonstrating substantial overall survival benefits in patients with platinum-resistant ovarian cancer. Treatment with relacorilant plus nab-paclitaxel chemotherapy achieved a meaningful 35% reduction in mortality risk compared to chemotherapy alone. Patients receiving the combination therapy reached a median overall survival of 16 months, compared to 11.9 months in the control group—a clinically meaningful improvement that addresses a critical gap in this cancer population.

This dual-agent approach proved therapeutically efficient without compromising safety. The combination maintained a tolerability profile consistent with nab-paclitaxel monotherapy, suggesting that relacorilant delivered additional clinical benefits without imposing additional burden on patients. For platinum-resistant ovarian cancer patients, who typically face grim prognosis with limited options, this efficacy data represents a potentially transformative therapeutic approach.

The ROSELLA trial advancement follows positive progression-free survival results announced in April 2025, when the study met its initial primary endpoint as assessed by blinded independent central review. Management indicated that relacorilant’s dual mechanism—achieving both PFS and OS improvements without requiring biomarker selection or enhanced safety monitoring—positions the combination as a potential new treatment standard for this malignancy.

Regulatory Trajectory and Global Market Expansion for Cancer Indication

The regulatory pathway for relacorilant in platinum-resistant ovarian cancer has progressed methodically through the FDA approval process. In September 2025, the regulatory agency accepted the new drug application (NDA) seeking approval for the relacorilant and nab-paclitaxel combination. A critical FDA decision is anticipated on July 11, 2026, which could mark another milestone for this cancer therapy.

International expansion efforts are simultaneously advancing. Corcept submitted a marketing authorization application to the European Medicines Agency, seeking approval for relacorilant in platinum-resistant ovarian cancer, with regulatory decision expected later in 2026. This parallel international strategy reflects confidence in the commercial potential of this cancer treatment across major markets.

Beyond single-agent strategies, Corcept is evaluating combination approaches in the phase II BELLA study, which incorporates relacorilant with both nab-paclitaxel and Roche’s Avastin (bevacizumab). This triple-agent investigation seeks to determine whether enhanced combination therapy offers additional clinical advantages for platinum-resistant ovarian cancer patients.

The development pipeline extends beyond platinum-resistant indications. Relacorilant is also undergoing evaluation in platinum-sensitive ovarian cancer, as well as other solid tumors including endometrial, cervical, pancreatic, and prostate cancers, suggesting a potentially broad oncology footprint for this therapeutic mechanism.

Previous Setback and Strategic Implications

Recent progress must be contextualized against a significant regulatory disappointment. Corcept recently received a complete response letter (CRL) from the FDA regarding relacorilant’s alternative indication in Cushing’s syndrome (endogenous hypercortisolism). Despite positive data from the GRACE study and supportive findings from the confirmatory GRADIENT trial, supplemented by long-term follow-up data and phase II evidence, the FDA determined that additional effectiveness evidence was required before approval could be granted.

This regulatory setback for the Cushing’s syndrome indication underscores the rigorous evidentiary standards applied by FDA, even when phase III and confirmatory trial data demonstrate clinical benefit. The delay impacts the company’s strategic objective to diversify revenue streams beyond Korlym, its sole marketed product for endogenous hypercortisolism and Cushing’s syndrome.

Korlym, the company’s established treatment, generated $559.3 million in sales during the first nine months of 2025, representing approximately 13.4% year-over-year growth. While this growth trajectory remains solid, reducing dependence on a single marketed product strengthens long-term commercial sustainability. The ovarian cancer indication therefore assumes heightened strategic importance as the company navigates the regulatory and commercial landscape.

Market Context and Stock Performance

In the six months preceding the ROSELLA breakthrough announcement, Corcept shares had declined 40%, substantially outpacing the broader biotech industry decline of 2.9%. The stock price movement on January 22 reflected investor reassessment of the company’s oncology prospects and pipeline potential, with shares advancing 13.7% following the positive cancer study readout.

The success of relacorilant in platinum-resistant ovarian cancer could potentially establish a new therapeutic category and strengthen Corcept’s position within the competitive oncology landscape, contingent upon satisfactory FDA review and eventual approval in this serious cancer indication.