On September 18, Corcept Therapeutics (NASDAQ:CORT) said Europe’s drug regulator recommended approval for the cancer therapy that has already earned a spot in US cancer treatment guidelines. The Committee for Medicinal Products for Human Use backed relacorilant, sold in the US as Lifyorli, for use alongside the chemotherapy drug nab-paclitaxel in patients with platinum-resistant ovarian cancer. The European Commission still has to sign off, but a positive CHMP opinion is usually the last real obstacle before that happens. For a company whose oncology business is barely a year old, the timing could not be better.
A Drug Finding Its Footing
The CHMP’s recommendation rests on Corcept’s pivotal Phase 3 ROSELLA trial, which enrolled 381 patients with platinum-resistant ovarian cancer at sites in the US, Europe, South Korea, Brazil, Argentina, Canada, and Australia. Patients who received relacorilant alongside nab-paclitaxel lived longer without their disease progressing and lived longer overall than those who received nab-paclitaxel alone, and the safety profile matched chemotherapy by itself. Corcept’s Chief Development Officer, Bill Guyer, has pointed to a 35 percent reduction in the risk of death for patients on the combination. The European Commission is expected to issue its final decision in the fourth quarter of 2026, opening a market where at least as many women qualify for treatment as in the US.
The US side of that story is already playing out. More than 1,300 patients have started Lifyorli since the FDA approved it in March, and Corcept says demand has picked up every month since. Lifyorli generated $47.6 million in its first quarter on the market, helping push total second-quarter revenue up 32 percent year over year to $256.1 million. That strength was broad enough that Corcept raised its full-year revenue guidance to $1.1 billion to $1.2 billion, and net income climbed to $43 million from $35.1 million a year earlier.
The Costs Of Growing Fast
Lifyorli is only a couple of quarters into its commercial life, and the spending required to launch it shows up clearly in the numbers. Second-quarter operating expenses rose to $214.8 million from $167.8 million a year earlier, a jump Corcept attributes to the Lifyorli launch and new investment in its Cushing’s syndrome business. The European opinion is also not a final answer. The European Commission still has to issue its own decision, and the fourth quarter of 2026 is a target, not a guarantee.
The disease itself limits how big this can get. Corcept estimates roughly 20,000 women become candidates for platinum-resistant ovarian cancer treatment each year in the United States, with about the same number in Europe, so Lifyorli is chasing a defined population rather than an open-ended market. Corcept is also running a wide slate of programs at once, from earlier-stage ovarian and endometrial cancer studies to a planned Phase 3 trial in ALS and a Phase 2b study in MASH, alongside a resubmitted Cushing’s syndrome drug application awaiting an FDA decision by December 17, 2026. Each program adds a shot at more revenue, but also another place where a disappointing readout could hit the stock.
A Split Verdict From Traders
Hedge fund ownership of Corcept fell to 30 funds in the most recent quarter, down from 41 the quarter before. That pullback runs against the good news coming out of Europe. Short sellers have not backed off either. Some 11.20 percent of the float is sold short, a level that points to a real bear camp rather than routine hedging. Yet the stock trades at a forward price-to-earnings ratio of just 18.15 as of September 21, cheap for a company guiding to $1.1 billion to $1.2 billion in revenue this year. That gap is the tension defining the stock right now.
What Happens Next Matters
Corcept has spent the months since Lifyorli’s March approval turning it into a real commercial business, and the CHMP’s recommendation gives it a plausible path to doing the same in Europe by year-end. The bull case rests on that European decision landing on schedule and Lifyorli’s monthly demand growth holding up as more patients start treatment. The bear case rests on rising launch costs, the fixed size of the platinum-resistant ovarian cancer population, and a pipeline broad enough that any single setback could dominate headlines.
READ NEXT: 10 Best Future Stocks to Buy Under $10 and 12 Best Performing Semiconductor Stocks to Invest In.
Hedge Fund Resource Center