What Happened?
Shares of biopharma company Corcept Therapeutics (NASDAQ:CORT)
jumped 5.4% in the afternoon session after the company announced it would present new data from its pivotal Phase 3 ROSELLA trial and that the U.S. Food and Drug Administration (FDA) accepted its New Drug Application for relacorilant, a treatment for platinum-resistant ovarian cancer.
The new, late-breaking data from the ROSELLA trial was set to be presented at the European Society for Medical Oncology (ESMO) Annual Meeting. The trial studied the drug relacorilant in patients with platinum-resistant ovarian cancer, a group with a particularly poor prognosis. In a separate and significant development, the company also confirmed that the FDA had accepted its New Drug Application for the same drug. This acceptance marked a formal step in the review process for potential market approval, signaling progress in bringing the new therapy to patients.
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What Is The Market Telling Us
Corcept’s shares are very volatile and have had 26 moves greater than 5% over the last year. In that context, today’s move indicates the market considers this news meaningful but not something that would fundamentally change its perception of the business.
The biggest move we wrote about over the last year was 6 months ago when the stock gained 94.9% on the news that the company announced that its Phase 3 trial (ROSELLA) met its goal of improving progression-free survival and overall survival in treating resistant ovarian cancer with a new therapy (a combination of Relacorilant and Nab-paclitaxel).
In a press release, the CORT said the mix worked better than chemotherapy alone using Nab-paclitaxel and didn't cause more side effects. The results pointed to Relacorilant as a strong choice for people with few treatment paths.
Corcept planned to file for approval in the U.S. and Europe by the end of the year, which is a key move towards commercializing the drug.
Overall, the data validates Corcept's cancer treatment result and shows that Relacorilant could stand out as a new cancer therapy.
Corcept is up 68.3% since the beginning of the year, but at $84.08 per share, it is still trading 26.4% below its 52-week high of $114.22 from March 2025. Investors who bought $1,000 worth of Corcept’s shares 5 years ago would now be looking at an investment worth $4,928.
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