- The approval is based on the results of Corcept’s Phase 3 ROSELLA trial, which showed improvements in both progression-free survival and overall survival.
- The approval covers adults with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer.
- The FDA recommended taking Relacorilant as a 150 mg pill once daily on the day before, the day of, and the day after each chemotherapy treatment.
Shares of Corcept Therapeutics (CORT) soared 35% on Wednesday, after the U.S. Food and Drug Administration approved Relacorilant, marketed by the company as Lifyorli, in combination with chemotherapy drug nab-paclitaxel, for advanced ovarian-related cancers.
CORT shares were placed under a trading halt for 27 minutes after the FDA’s approval announcement.
The approval covers adults with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer who have already undergone prior therapies, including the FDA-approved Bevacizumab.
Improvements in Overall and Progression-Free Survival
The approval is based on the results of the company’s Phase 3 ROSELLA trial in 381 patients, which showed improvements in both progression-free survival and overall survival.
Patients receiving the combination therapy lived a median of 16 months, compared to 11.9 months for those treated with chemotherapy alone. Progression-free survival also improved to 6.5 months, up from 5.5 months.
The combination therapy was generally well tolerated, with side effects consistent with standard chemotherapy. Common adverse events included low blood counts, fatigue, nausea, and diarrhea, along with risks such as infections and adrenal-related effects.
Relacorilant is an oral drug that works by blocking the glucocorticoid receptor to regulate cortisol activity without affecting other hormone systems.
FDA Approval Comes Sooner Than Expected
The approval comes way before expected. In January, Corcept said that the FDA assigned a Prescription Drug User Fee Act (PDUFA) date of July 11, 2026, for Relacorilant.
The FDA recommended taking Relacorilant as a 150 mg pill once daily on the day before, the day of, and the day after each nab-paclitaxel treatment. Nab-paclitaxel was recommended as an IV infusion at 80 mg/m² on Days 1, 8, and 15 of each 28-day cycle. The drug works by blocking glucocorticoid receptors.
Retail sentiment on Stocktwits turned ‘bullish’ from ‘neutral’ a day earlier, amid ‘high’ message volumes.
What Did Stocktwits Users Say?
One user recommended holding the stock, as it could climb to $100.
Another user said the company is an attractive acquisition target.
Year-to-date, the stock has gained around 25%.
Read also: UUUU Stock Gets Pre-Market Boost On Rare Earth Production Breakthrough – Here’s Why It Matters
For updates and corrections, email newsroom[at]stocktwits[dot]com.