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Corcept Resubmits NDA for Relacorilant in Cushing's Syndrome
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Key Takeaways
CORT resubmitted its NDA for relacorilant as a treatment for Cushing's syndrome.
The resubmission includes additional analyses requested by the FDA from the original filing.
Positive GRACE and phase III GRADIENT data and other studies supported the resubmitted application.
Corcept Therapeutics (CORT - Free Report) announced that it has resubmitted the new drug application (NDA) for its proprietary, selective cortisol modulator, relacorilant, to the FDA as a treatment for patients with Cushing’s syndrome.
Corcept expects to receive a six-month review period for the resubmitted NDA for relacorilant in Cushing’s syndrome. The resubmission includes additional analyses of data from the original NDA submission, as requested by the FDA.
The resubmitted NDA was based on positive data from the GRACE study, the placebo-controlled phase III GRADIENT study, as well as long-term extension studies and earlier-stage development data.
Per management, the data from these studies demonstrate that relacorilant can provide meaningful and durable improvements in the signs and symptoms of Cushing’s syndrome, while avoiding some of the serious side effects associated with currently approved therapies.
CORT’s Price Performance
Year to date, shares of Corcept have soared 134.9% against the industry’s decline of 9.1%.
Image Source: Zacks Investment Research
CORT’s Earlier Hurdle With Relacorilant in Cushing’s Syndrome
In December 2025, the FDA issued a complete response letter (“CRL”) to the NDA for relacorilant as a treatment of Cushing’s syndrome.
Following the issuance of the CRL, the FDA asked the company to conduct additional analyses of the NDA data.
In December 2024, the company submitted an NDA for relacorilant to the FDA for treating patients with 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.
A potential approval for relacorilant in Cushing's syndrome should help Corcept reduce the heavy dependence on its sole-marketed drug, Korlym, which is also approved for treating Cushing's syndrome.
Corcept has also submitted a marketing authorization application to the European Medicines Agency, seeking approval for relacorilant plus nab-paclitaxel to treat patients with platinum-resistant ovarian cancer. A final decision in Europe is expected by the end of 2026.
The approval of Lifyorli is likely to help Corcept diversify its revenue base, given that the company’s top line was solely dependent on Korlym. The approval of Lifyorli should lower the company’s heavy dependence on Korlym for revenues. The company is likely to record Lifyorli sales from the second quarter of 2026.
Over the past 60 days, estimates for Indivior Pharmaceuticals’ 2026 earnings per share have risen from $3.33 to $4.05, while estimates for 2027 have increased from $3.66 to $4.27 during the same time. INDV shares have risen 5.7% year to date.
Indivior Pharmaceuticals’ earnings beat estimates in each of the trailing four quarters, with the average surprise being 65.44%.
Over the past 60 days, estimates for Immunocore’s 2026 bottom line have improved from a loss of 88 cents per share to earnings of 6 cents. Over the same period, EPS estimates for 2027 have risen from 24 cents to 87 cents. IMCR stock has lost 17.7% year to date.
Immunocore’s earnings beat estimates in three of the trailing four quarters, while missing the same on the remaining occasion, with the average surprise being 46.66%.
Over the past 60 days, estimates for Liquidia’s 2026 earnings per share have risen from $1.50 to $2.97, while estimates for 2027 have increased from $2.91 to $4.81 during the same time. LQDA shares have surged 99.1% year to date.
Liquidia’s earnings beat estimates in three of the trailing four quarters, while missing the same on the remaining occasion, with the average surprise being 54.40%.
View the Zacks #1 Rank List
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Corcept Resubmits NDA for Relacorilant in Cushing's Syndrome
Key Takeaways
Corcept Therapeutics (CORT - Free Report) announced that it has resubmitted the new drug application (NDA) for its proprietary, selective cortisol modulator, relacorilant, to the FDA as a treatment for patients with Cushing’s syndrome.
Corcept expects to receive a six-month review period for the resubmitted NDA for relacorilant in Cushing’s syndrome. The resubmission includes additional analyses of data from the original NDA submission, as requested by the FDA.
The resubmitted NDA was based on positive data from the GRACE study, the placebo-controlled phase III GRADIENT study, as well as long-term extension studies and earlier-stage development data.
Per management, the data from these studies demonstrate that relacorilant can provide meaningful and durable improvements in the signs and symptoms of Cushing’s syndrome, while avoiding some of the serious side effects associated with currently approved therapies.
CORT’s Price Performance
Year to date, shares of Corcept have soared 134.9% against the industry’s decline of 9.1%.
Image Source: Zacks Investment Research
CORT’s Earlier Hurdle With Relacorilant in Cushing’s Syndrome
In December 2025, the FDA issued a complete response letter (“CRL”) to the NDA for relacorilant as a treatment of Cushing’s syndrome.
Following the issuance of the CRL, the FDA asked the company to conduct additional analyses of the NDA data.
In December 2024, the company submitted an NDA for relacorilant to the FDA for treating patients with 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.
A potential approval for relacorilant in Cushing's syndrome should help Corcept reduce the heavy dependence on its sole-marketed drug, Korlym, which is also approved for treating Cushing's syndrome.
CORT’s Relacorilant Approved in Ovarian Cancer
In March 2026, the FDA approved Lifyorli (relacorilant) in combination with nab-paclitaxel for the treatment of adult patients with platinum-resistant ovarian cancer.
Corcept has also submitted a marketing authorization application to the European Medicines Agency, seeking approval for relacorilant plus nab-paclitaxel to treat patients with platinum-resistant ovarian cancer. A final decision in Europe is expected by the end of 2026.
The approval of Lifyorli is likely to help Corcept diversify its revenue base, given that the company’s top line was solely dependent on Korlym. The approval of Lifyorli should lower the company’s heavy dependence on Korlym for revenues. The company is likely to record Lifyorli sales from the second quarter of 2026.
CORT's Zacks Rank & Stocks to Consider
Corcept currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks in the drug/biotech sector are Indivior Pharmaceuticals (INDV - Free Report) , Immunocore (IMCR - Free Report) and Liquidia Corporation (LQDA - Free Report) , each currently sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Over the past 60 days, estimates for Indivior Pharmaceuticals’ 2026 earnings per share have risen from $3.33 to $4.05, while estimates for 2027 have increased from $3.66 to $4.27 during the same time. INDV shares have risen 5.7% year to date.
Indivior Pharmaceuticals’ earnings beat estimates in each of the trailing four quarters, with the average surprise being 65.44%.
Over the past 60 days, estimates for Immunocore’s 2026 bottom line have improved from a loss of 88 cents per share to earnings of 6 cents. Over the same period, EPS estimates for 2027 have risen from 24 cents to 87 cents. IMCR stock has lost 17.7% year to date.
Immunocore’s earnings beat estimates in three of the trailing four quarters, while missing the same on the remaining occasion, with the average surprise being 46.66%.
Over the past 60 days, estimates for Liquidia’s 2026 earnings per share have risen from $1.50 to $2.97, while estimates for 2027 have increased from $2.91 to $4.81 during the same time. LQDA shares have surged 99.1% year to date.
Liquidia’s earnings beat estimates in three of the trailing four quarters, while missing the same on the remaining occasion, with the average surprise being 54.40%.