Corcept Therapeutics Incorporated (CORT – Free Report) recently announced the submission of a new drug application (NDA) to the FDA for its proprietary, selective cortisol modulator, relacorilant, to treat patients with endogenous hypercortisolism (Cushing’s syndrome).
Relacorilant is a selective cortisol modulator that binds to the glucocorticoid receptor but not to the body’s other hormone receptors.
The NDA is based on positive results from the GRACE trial and confirmatory evidence from the late-stage GRADIENT and long-term extension studies and a phase II study in hypercortisolism.
Results from the study showed that patients in these studies who received relacorilant experienced improvements in a wide array of hypercortisolism’s signs and symptoms, with an acceptable safety burden.
Results further showed the absence of instances of drug-induced adrenal insufficiency, hypokalemia or QT prolongation – serious adverse events that can arise in patients taking currently approved medications – and no adverse events associated with activity at the progesterone receptor, such as endometrial thickening or vaginal bleeding.
Shares of CORT have rallied 56.6% this year against the industry’s decline of 9.4%.
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Potential Approval of Relacorilant Should Boost CORT
CORT’s sole marketed drug, Korlym (mifepristone), is already approved for treating Cushing’s syndrome. The drug has been witnessing a strong demand in the past couple of quarters and the trend is likely to continue in 2025.
Corcept is also studying relacorilant for ovarian, adrenal and prostate cancer. The candidate enjoys orphan drug designation in the United States and the European Union for the treatment of Cushing’s syndrome.
The successful development and potential approval for relacorilant should help Corcept address a broader patient population.
CORT’s Stupendous Performance in 2024
Corcept’s top line solely comprises product sales from Korlym. The drug has been a consistent revenue driver for the company since approval. Sales of the drug increased 42.1% year over year to $493.2 million in the first nine months of 2024, owing to the strong demand and a record number of patients receiving the medication.
Owing to the strong performance, CORT increased its annual revenue guidance for Korlym concurrently with third-quarter results. The company now expects total revenues in the range of $675-$700 million compared with the earlier projection of $640-$670 million.
CORT’s Zacks Rank & Other Key Picks
Corcept currently flaunts a Zacks Rank #1 (Strong Buy).
Other top-ranked stocks in the healthcare sector include Bristol Myers Squibb (BMY – Free Report) and Rigel Pharmaceuticals (RIGL – Free Report) , both sporting a Zacks Rank 1. You can see the complete list of today’s Zacks #1 Rank stocks here.
Over the past 60 days, estimates for Bristol Myers’ 2024 earnings have increased from 79 cents to 93 cents per share. Estimates for 2025 earnings per share have increased from $7.03 to $7.19 in the same time frame. BMY’s shares have gained 15.8% in the past six months.
Bristol Myers’ earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 15.54%.
Over the past 60 days, estimates for RIGL’s 2025 earnings have increased from 55 cents to 92 cents per share. RIGL’s shares have surged 95.9% in the past six months.
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