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Will Corcept (CORT) Bank on Korlym in 2024 Amid Stiff Rivalry?
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Corcept Therapeutics Incorporated (CORT - Free Report) has made steady progress with its sole marketed drug, Korlym (mifepristone), which is approved for the treatment of hyperglycemia secondary to hypercortisolism in adult patients with endogenous Cushing’s syndrome suffering from type II diabetes or glucose intolerance and who have failed surgery or are not suitable for surgery.
The company’s top line solely comprises product sales from Korlym.
Korlym enjoys an orphan drug status in the United States and Europe for treating Cushing’s syndrome.
The drug has been a consistent revenue driver since its approval and launch.
Korlym recorded sales of $482.4 million in 2023, up around 20% year over year. The company expects total revenues in the range of $600-$630 million in 2024.
This apart, CORT is evaluating its lead pipeline candidate, relacorilant, in phase III of the GRACE study to treat Cushing’s syndrome. A new drug application is expected to be submitted in the second quarter of 2024.
The phase III GRADIENT study, evaluating relacorilant for patients whose Cushing’s syndrome is caused by adrenal adenoma, is currently enrolling patients. Data from the same is expected in the second half of 2025.
A phase Ib study is evaluating relacorilant in combination with Merck’s (MRK - Free Report) blockbuster PD-1 checkpoint inhibitor, Keytruda (pembrolizumab), for treating patients with adrenal cancer with cortisol excess completed enrolment. Data from the study is expected in mid-2024.
Merck’s biggest revenue generator, Keytruda, is approved for treating several cancer indications. Sales of Keytruda came in at $25 billion in 2023.
MRK continues to evaluate Keytruda in combination studies for various other indications.
Corcept is also evaluating relacorilant in combination studies for treating solid tumors.
The company is also enrolling patients in the phase II DAZALS study of its selective cortisol modulator, dazucorilant, for treating patients with amyotrophic lateral sclerosis. Data from this study is expected by 2024-end.
The steady performance of Korlym, along with encouraging pipeline progress, is likely to maintain the upward momentum for CORT in 2024.
However, Korlym faces stiff competition from several other medicines that are approved for treating Cushing’s syndrome in both the United States and the European Union.
In December 2023, Corcept faced a major setback after the United States district court for the district of New Jersey passed its judgment on the company’s patent infringement lawsuit against Teva Pharmaceuticals (TEVA - Free Report) .
The patent infringement lawsuit was related to Korlym.
The United States district court ruled in favor of Teva as Corcept did not meet its burden of proof and failed to demonstrate the likelihood of direct infringement of its patent by Teva.
Such events can be detrimental to Corcept’s growth prospects as it is solely dependent on Korlym for revenues.
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Will Corcept (CORT) Bank on Korlym in 2024 Amid Stiff Rivalry?
Corcept Therapeutics Incorporated (CORT - Free Report) has made steady progress with its sole marketed drug, Korlym (mifepristone), which is approved for the treatment of hyperglycemia secondary to hypercortisolism in adult patients with endogenous Cushing’s syndrome suffering from type II diabetes or glucose intolerance and who have failed surgery or are not suitable for surgery.
The company’s top line solely comprises product sales from Korlym.
Korlym enjoys an orphan drug status in the United States and Europe for treating Cushing’s syndrome.
The drug has been a consistent revenue driver since its approval and launch.
Korlym recorded sales of $482.4 million in 2023, up around 20% year over year. The company expects total revenues in the range of $600-$630 million in 2024.
This apart, CORT is evaluating its lead pipeline candidate, relacorilant, in phase III of the GRACE study to treat Cushing’s syndrome. A new drug application is expected to be submitted in the second quarter of 2024.
The phase III GRADIENT study, evaluating relacorilant for patients whose Cushing’s syndrome is caused by adrenal adenoma, is currently enrolling patients. Data from the same is expected in the second half of 2025.
A phase Ib study is evaluating relacorilant in combination with Merck’s (MRK - Free Report) blockbuster PD-1 checkpoint inhibitor, Keytruda (pembrolizumab), for treating patients with adrenal cancer with cortisol excess completed enrolment. Data from the study is expected in mid-2024.
Merck’s biggest revenue generator, Keytruda, is approved for treating several cancer indications. Sales of Keytruda came in at $25 billion in 2023.
MRK continues to evaluate Keytruda in combination studies for various other indications.
Corcept is also evaluating relacorilant in combination studies for treating solid tumors.
The company is also enrolling patients in the phase II DAZALS study of its selective cortisol modulator, dazucorilant, for treating patients with amyotrophic lateral sclerosis. Data from this study is expected by 2024-end.
The steady performance of Korlym, along with encouraging pipeline progress, is likely to maintain the upward momentum for CORT in 2024.
However, Korlym faces stiff competition from several other medicines that are approved for treating Cushing’s syndrome in both the United States and the European Union.
In December 2023, Corcept faced a major setback after the United States district court for the district of New Jersey passed its judgment on the company’s patent infringement lawsuit against Teva Pharmaceuticals (TEVA - Free Report) .
The patent infringement lawsuit was related to Korlym.
The United States district court ruled in favor of Teva as Corcept did not meet its burden of proof and failed to demonstrate the likelihood of direct infringement of its patent by Teva.
Such events can be detrimental to Corcept’s growth prospects as it is solely dependent on Korlym for revenues.