Corcept Stock At New High; Will The Upcoming Regulatory And Clinical Trial Catalysts Take It Higher?

(RTTNews) - Corcept Therapeutics Inc. (CORT), which posted strong financial results for the third quarter yesterday, is anticipating a transformative fourth quarter, with a key regulatory milestone and important data readouts expected by year-end.

The company has one marketed drug, Korlym, used to treat high blood sugar (hyperglycemia) caused by high cortisol levels in the blood (hypercortisolism) in adults with endogenous Cushing's syndrome who have type 2 diabetes mellitus or glucose intolerance and have failed surgery or cannot have surgery. The drug, which received FDA approval in February 2012, has experienced significant revenue growth since its launch, increasing from $3.31 million in 2012 to $482.4 million in 2023.

For the third quarter ended September 30, 2024, Korlym generated net product revenue of $182.5 million compared to $123.6 million in the third quarter of 2023, an increase of 48%. Net income jumped to $47.2 million or $0.41 per share in the third quarter of 2024, from $31.4 million or $0.28 per share in the year-ago quarter.

As the company continues to expand its network of Korlym prescribers and sees a growing number of patients receiving Korlym treatment, it has raised its 2024 revenue outlook for the third time.

Accordingly, Corcept now expects full-year 2024 revenue to range between $675 million and $700 million, up from its prior revised outlook range of $640 million to $670 million. This updated guidance represents revenue growth of approximately 40% to 45% compared to 2023.

In the Pipeline

A phase 4 trial of Korlym in patients with hypercortisolism and difficult-to-control type 2 diabetes, dubbed CATALYST, is underway, with results expected this quarter.

The company's lead drug candidate is Relacorilant, a non-steroidal, selective glucocorticoid receptor modulator that is being evaluated in a variety of serious disorders, including Cushing's syndrome, ovarian cancer, and adrenal cancer.

Relacorilant has been successfully studied in a pivotal phase III trial in patients with all etiologies of Cushing's syndrome, with the submission of a New Drug Application planned for this quarter.

A pivotal phase III trial of Relacorilant plus nab-paclitaxel in patients with platinum-resistant ovarian cancer, dubbed ROSELLA, is ongoing, with results due by the end of this year.

A phase II trial of Relacorilant plus enzalutamide in patients with early-stage prostate cancer is ongoing. This study is being conducted in collaboration with the University of Chicago.

Dazucorilant and Miricorilant are among the company's other major clinical drug candidates.

Dazucorilant is under a phase II trial in patients with Amyotrophic Lateral Sclerosis, dubbed DAZALS, with results expected this quarter.

A phase IIb trial of Miricorilant in patients with biopsy-confirmed metabolic dysfunction-associated steatohepatitis (MASH) and presumed MASH, dubbed MONARCH, is ongoing.

Cash Position

The company's cash and investments were $547.6 million as of September 30, 2024.

When we alerted readers to CORT on June 21, 2024, it was trading at $29.18. The stock touched an all-time high of $51.32 during intraday trading yesterday, before closing at $50.06.