Corcept Therapeutics (NASDAQ:CORT) shares surged more than 85% after the company announced positive results from its Phase 3 ROSELLA trial, evaluating relacorilant combined with nab-paclitaxel in patients with platinum-resistant ovarian cancer, that will support regulatory applications in the US and Europe.
The trial met its primary endpoint, demonstrating a 30% reduction in the risk of disease progression compared to nab-paclitaxel alone.
Median progression-free survival was 6.5 months for the combination therapy group compared to 5.5 months for the control group.
Median overall survival improved to 16 months, compared to 11.5 months for the control group.
The trial enrolled 381 patients across the United States, Europe, South Korea, Brazil, Argentina, Canada, and Australia.
The trial results will support a New Drug Application (NDA) in the United States and a Marketing Authorization Application (MAA) in Europe. The company expects to submit its NDA in Q3 with the MAA to follow shortly afterwards.
“The improvement in survival seen in ROSELLA, without an increased safety burden, brings us closer to delivering a new standard-of-care treatment for patients with platinum-resistant ovarian cancer,” Corcept chief development officer Bill Guyer said in a statement.
Shares of Corcept added 86% at about $101 in the early afternoon on Monday.