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Corcept Seeks FDA Approval for Relacorilant in Ovarian Cancer
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Key Takeaways
CORT filed its new NDA for relacorilant plus nab-paclitaxel in platinum-resistant ovarian cancer.
The ROSELLA study showed improved progression-free survival for relacorilant plus nab-paclitaxel.
CORT aims to broaden its reach beyond Korlym and lessen reliance on a single approved drug.
Corcept Therapeutics (CORT - Free Report) announced that it has submitted a new drug application (NDA) to the FDA seeking approval for its lead pipeline candidate, relacorilant, for treating a new indication.
The company is seeking approval for relacorilant in combination with nab-paclitaxel for treating patients with platinum-resistant ovarian cancer. This marks a new NDA for relacorilant.
Last December, the company submitted an NDA for relacorilant to the FDA for treating patients with hypercortisolism (Cushing's syndrome).
The NDA for relacorilant in platinum-resistant ovarian cancer was based on data from the pivotal phase III ROSELLA study and phase II studies.
Recently, the company announced that the ROSELLA study met its primary endpoint of improved progression-free survival, as assessed by blinded independent central review (PFS-BICR). Per management, data from the ROSELLA study suggested that the combo of relacorilant plus nab-paclitaxel has the potential to become a new standard of care for patients with platinum-resistant ovarian cancer.
CORT's Price Performance
Year to date, shares of Corcept have rallied 44.4% compared with the industry’s rise of 4.1%.
Image Source: Zacks Investment Research
Relacorilant’s Potential Nod for Hypercortisolism May Boost CORT
In March 2025, the FDA accepted the NDA for relacorilant to treat hypercortisolism. The regulatory body has assigned a Prescription Drug User Fee Act target action date of Dec. 30, 2025.
This NDA was based on positive data from the GRACE study and confirmatory evidence from the phase III GRADIENT, as well as long-term extension studies and a phase II study in hypercortisolism.
Meanwhile, CORT’s sole marketed drug, Korlym (mifepristone), is already approved for treating Cushing's syndrome. The drug generated sales worth $157.2 million in the first quarter of 2025, up 7.1% year over year on the back of strong demand.
A potential approval for relacorilant should help Corcept address a broader patient population and reduce the heavy dependence on Korlym for growth in the long run.
CORT's Other Pipeline Studies
Corcept is also evaluating relacorilant plus nab-paclitaxel and Roche’s (RHHBY - Free Report) Avastin (bevacizumab) in the phase II BELLA study for treating patients with platinum-resistant ovarian cancer.
Per management, the BELLA study will help in understanding whether combining relacorilant with two medicines — nab-paclitaxel and RHHBY’s Avastin — offers patients an additional treatment option or not.
Corcept is also evaluating relacorilant plus Xtandi (enzalutamide) in patients with early-stage prostate cancer. The study is being conducted in collaboration with the University of Chicago.
The company is evaluating its selective cortisol modulator dazucorilant in a mid-stage study for treating patients with amyotrophic lateral sclerosis (ALS), a devastating neuromuscular disorder.
Corcept is also evaluating another candidate, miricorilant, in a mid-stage study for treating patients with biopsy-confirmed or presumed metabolic dysfunction-associated steatohepatitis.
CORT's Zacks Rank
Corcept currently carries a Zacks Rank #5 (Strong Sell).
In the past 60 days, estimates for Arvinas’ 2025 loss per share have improved from $1.60 to $1.51. Loss per share estimates for 2026 have narrowed from $3.28 to $2.98 during the same period. ARVN stock has plunged 58.9% year to date.
Arvinas’ earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 82.09%.
In the past 60 days, estimates for Akero Therapeutics’ 2025 loss per share have improved from $4.00 to $3.96. Loss per share estimates for 2026 have narrowed from $4.34 to $4.27 during the same period. Year to date, shares of AKRO have surged 89.5%.
Akero Therapeutics’ earnings beat estimates in three of the trailing four quarters, while missing the same on the remaining occasion, the average surprise being 48.90%.
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Corcept Seeks FDA Approval for Relacorilant in Ovarian Cancer
Key Takeaways
Corcept Therapeutics (CORT - Free Report) announced that it has submitted a new drug application (NDA) to the FDA seeking approval for its lead pipeline candidate, relacorilant, for treating a new indication.
The company is seeking approval for relacorilant in combination with nab-paclitaxel for treating patients with platinum-resistant ovarian cancer. This marks a new NDA for relacorilant.
Last December, the company submitted an NDA for relacorilant to the FDA for treating patients with hypercortisolism (Cushing's syndrome).
The NDA for relacorilant in platinum-resistant ovarian cancer was based on data from the pivotal phase III ROSELLA study and phase II studies.
Recently, the company announced that the ROSELLA study met its primary endpoint of improved progression-free survival, as assessed by blinded independent central review (PFS-BICR). Per management, data from the ROSELLA study suggested that the combo of relacorilant plus nab-paclitaxel has the potential to become a new standard of care for patients with platinum-resistant ovarian cancer.
CORT's Price Performance
Year to date, shares of Corcept have rallied 44.4% compared with the industry’s rise of 4.1%.
Image Source: Zacks Investment Research
Relacorilant’s Potential Nod for Hypercortisolism May Boost CORT
In March 2025, the FDA accepted the NDA for relacorilant to treat hypercortisolism. The regulatory body has assigned a Prescription Drug User Fee Act target action date of Dec. 30, 2025.
This NDA was based on positive data from the GRACE study and confirmatory evidence from the phase III GRADIENT, as well as long-term extension studies and a phase II study in hypercortisolism.
Meanwhile, CORT’s sole marketed drug, Korlym (mifepristone), is already approved for treating Cushing's syndrome. The drug generated sales worth $157.2 million in the first quarter of 2025, up 7.1% year over year on the back of strong demand.
A potential approval for relacorilant should help Corcept address a broader patient population and reduce the heavy dependence on Korlym for growth in the long run.
CORT's Other Pipeline Studies
Corcept is also evaluating relacorilant plus nab-paclitaxel and Roche’s (RHHBY - Free Report) Avastin (bevacizumab) in the phase II BELLA study for treating patients with platinum-resistant ovarian cancer.
Per management, the BELLA study will help in understanding whether combining relacorilant with two medicines — nab-paclitaxel and RHHBY’s Avastin — offers patients an additional treatment option or not.
Corcept is also evaluating relacorilant plus Xtandi (enzalutamide) in patients with early-stage prostate cancer. The study is being conducted in collaboration with the University of Chicago.
The company is evaluating its selective cortisol modulator dazucorilant in a mid-stage study for treating patients with amyotrophic lateral sclerosis (ALS), a devastating neuromuscular disorder.
Corcept is also evaluating another candidate, miricorilant, in a mid-stage study for treating patients with biopsy-confirmed or presumed metabolic dysfunction-associated steatohepatitis.
CORT's Zacks Rank
Corcept currently carries a Zacks Rank #5 (Strong Sell).
Stocks to Consider
Some better-ranked stocks from the biotech sector are Arvinas (ARVN - Free Report) and Akero Therapeutics (AKRO - Free Report) , each sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
In the past 60 days, estimates for Arvinas’ 2025 loss per share have improved from $1.60 to $1.51. Loss per share estimates for 2026 have narrowed from $3.28 to $2.98 during the same period. ARVN stock has plunged 58.9% year to date.
Arvinas’ earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 82.09%.
In the past 60 days, estimates for Akero Therapeutics’ 2025 loss per share have improved from $4.00 to $3.96. Loss per share estimates for 2026 have narrowed from $4.34 to $4.27 during the same period. Year to date, shares of AKRO have surged 89.5%.
Akero Therapeutics’ earnings beat estimates in three of the trailing four quarters, while missing the same on the remaining occasion, the average surprise being 48.90%.