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CORT to Resubmit NDA for Relacorilant in Cushing's Syndrome, Stock Up
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Key Takeaways
Corcept plans to resubmit relacorilant's NDA for Cushing's syndrome in the coming weeks.
CORT reported positive analyses, and FDA discussions supported the NDA resubmission.
FDA informed that the PDUFA date would be about six months after the NDA resubmission.
Shares of Corcept Therapeutics (CORT - Free Report) were up 10.4% yesterday after the company announced that it will resubmit the new drug application (NDA) for its proprietary, selective cortisol modulator, relacorilant, to the FDA for treating patients with 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.
Year to date, shares of Corcept have rallied 91.5% against the industry’s decline of 6.4%.
Image Source: Zacks Investment Research
More on CORT’s Relacorilant in Cushing’s Syndrome
Following the issuance of the CRL, the FDA asked the company to conduct additional analyses of the NDA data. Based on the positive results of those analyses and the constructive discussions with the agency, CORT now plans to resubmit the NDA for relacorilant for treating Cushing’s syndrome in the upcoming weeks.
The regulatory body has also informed that the Prescription Drug User Fee Act (PDUFA) date would be approximately six months after the resubmission of the NDA.
In December 2024, the company submitted an NDA for relacorilant to the FDA for treating patients with hypercortisolism (Cushing's syndrome).
The NDA was based on positive data from the GRACE study and confirmatory evidence from the phase III GRADIENT study, as well as long-term extension studies and a phase II study in hypercortisolism.
Relacorilant is a selective cortisol modulator that binds to the glucocorticoid receptor but not to the body's other hormone receptors.
CORT’s Recent Development With Relacorilant 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. Following the nod, Lifyorli became the first FDA-approved selective glucocorticoid receptor antagonist for the given indication.
The FDA nod for the Lifyorli combo was based on data from the phase III ROSELLA study.
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, which is approved for treating Cushing's syndrome. 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 $3.10 to $3.35, while estimates for 2027 have increased from $3.47 to $3.69 during the same time. INDV shares have risen 4.6% 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, 2026 loss per share estimates for Immunocore have narrowed from 97 cents to 16 cents, while estimates for 2027 have moved from a loss of 39 cents per share to earnings of 11 cents during the same time. IMCR stock has lost 17.8% 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 79.9% 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%.
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CORT to Resubmit NDA for Relacorilant in Cushing's Syndrome, Stock Up
Key Takeaways
Shares of Corcept Therapeutics (CORT - Free Report) were up 10.4% yesterday after the company announced that it will resubmit the new drug application (NDA) for its proprietary, selective cortisol modulator, relacorilant, to the FDA for treating patients with 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.
Year to date, shares of Corcept have rallied 91.5% against the industry’s decline of 6.4%.
Image Source: Zacks Investment Research
More on CORT’s Relacorilant in Cushing’s Syndrome
Following the issuance of the CRL, the FDA asked the company to conduct additional analyses of the NDA data. Based on the positive results of those analyses and the constructive discussions with the agency, CORT now plans to resubmit the NDA for relacorilant for treating Cushing’s syndrome in the upcoming weeks.
The regulatory body has also informed that the Prescription Drug User Fee Act (PDUFA) date would be approximately six months after the resubmission of the NDA.
In December 2024, the company submitted an NDA for relacorilant to the FDA for treating patients with hypercortisolism (Cushing's syndrome).
The NDA was based on positive data from the GRACE study and confirmatory evidence from the phase III GRADIENT study, as well as long-term extension studies and a phase II study in hypercortisolism.
Relacorilant is a selective cortisol modulator that binds to the glucocorticoid receptor but not to the body's other hormone receptors.
CORT’s Recent Development With Relacorilant 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. Following the nod, Lifyorli became the first FDA-approved selective glucocorticoid receptor antagonist for the given indication.
The FDA nod for the Lifyorli combo was based on data from the phase III ROSELLA study.
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, which is approved for treating Cushing's syndrome. 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.
Corcept Therapeutics Incorporated Price
Corcept Therapeutics Incorporated price | Corcept Therapeutics Incorporated Quote
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 $3.10 to $3.35, while estimates for 2027 have increased from $3.47 to $3.69 during the same time. INDV shares have risen 4.6% 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, 2026 loss per share estimates for Immunocore have narrowed from 97 cents to 16 cents, while estimates for 2027 have moved from a loss of 39 cents per share to earnings of 11 cents during the same time. IMCR stock has lost 17.8% 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 79.9% 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%.