We use cookies to understand how you use our site and to improve your experience.
This includes personalizing content and advertising.
By pressing "Accept All" or closing out of this banner, you consent to the use of all cookies and similar technologies and the sharing of information they collect with third parties.
You can reject marketing cookies by pressing "Deny Optional," but we still use essential, performance, and functional cookies.
In addition, whether you "Accept All," Deny Optional," click the X or otherwise continue to use the site, you accept our Privacy Policy and Terms of Service, revised from time to time.
You are being directed to ZacksTrade, a division of LBMZ Securities and licensed broker-dealer. ZacksTrade and Zacks.com are separate companies. The web link between the two companies is not a solicitation or offer to invest in a particular security or type of security. ZacksTrade does not endorse or adopt any particular investment strategy, any analyst opinion/rating/report or any approach to evaluating individual securities.
If you wish to go to ZacksTrade, click OK. If you do not, click Cancel.
CORT Files MAA for Relacorilant in Platinum-Resistant Ovarian Cancer
Read MoreHide Full Article
Key Takeaways
Corcept submitted an MAA to the EMA for relacorilant in platinum-resistant ovarian cancer.
The filing is supported by phase III ROSELLA data showing improved survival with relacorilant combo therapy.
Approval could broaden CORT's reach and reduce reliance on its only marketed drug, Korlym.
Corcept Therapeutics (CORT - Free Report) announced that it has submitted a marketing authorization application (MAA) seeking approval for its lead pipeline candidate, relacorilant, to treat patients with platinum-resistant ovarian cancer to the European Medicines Agency (EMA).
The MAA was based on positive data from the pivotal phase III ROSELLA study and phase II studies, which evaluated relacorilant in combination with nab-paclitaxel for treating patients with platinum-resistant ovarian cancer.
Data from the same showed that patients who were treated with relacorilant plus nab-paclitaxel experienced improved progression-free and overall survival versus those who received nab-paclitaxel monotherapy, with no need for biomarker selection.
Last month, the FDA accepted the new drug application (NDA) for relacorilant for treating patients with platinum-resistant ovarian cancer. A final decision from the regulatory body is expected on July 11, 2026.
CORT’s Price Performance
Year to date, shares of Corcept have rallied 43.1% compared with the industry’s rise of 7.4%.
Image Source: Zacks Investment Research
CORT's Ongoing Development Activities With Relacorilant
Corcept is also developing relacorilant for treating Cushing’s syndrome.
In December 2024, the company submitted an NDA for relacorilant to the FDA for treating patients with hypercortisolism (Cushing's syndrome). The regulatory body has assigned a Prescription Drug User Fee Act target action date of Dec. 30, 2025.
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.
Notably, Corcept’s sole marketed drug, Korlym (mifepristone), is already approved for treating Cushing's syndrome. The drug generated sales worth $351.6 million in the first half of 2025, up 13.2% year over year.
A potential approval of relacorilant could enable Corcept to reach a broader patient population and lessen its heavy reliance on Korlym for future growth.
CORT's Zacks Rank & Stocks to Consider
Corcept currently carries a Zacks Rank #5 (Strong Sell).
In the past 60 days, estimates for Chemomab Therapeutics’ 2025 loss per share have narrowed from $2.40 to 60 cents. Loss per share estimates for 2026 have narrowed from $2.80 to $1.00 during the same period. CMMB stock has plunged 52.4% year to date.
Chemomab Therapeutics’ earnings beat estimates in three of the trailing four quarters, while meeting the same on the remaining occasion, with the average surprise being 26.25%.
In the past 60 days, estimates for ANI Pharmaceuticals’ 2025 earnings per share have risen from $7.25 to $7.29. During the same period, earnings per share estimates for 2026 have increased from $7.74 to $7.79. Year to date, ANIP’s shares have rallied 60.5%.
ANI Pharmaceuticals’ earnings beat estimates in each of the trailing four quarters, with the average surprise being 22.66%.
See More Zacks Research for These Tickers
Normally $25 each - click below to receive one report FREE:
Image: Bigstock
CORT Files MAA for Relacorilant in Platinum-Resistant Ovarian Cancer
Key Takeaways
Corcept Therapeutics (CORT - Free Report) announced that it has submitted a marketing authorization application (MAA) seeking approval for its lead pipeline candidate, relacorilant, to treat patients with platinum-resistant ovarian cancer to the European Medicines Agency (EMA).
The MAA was based on positive data from the pivotal phase III ROSELLA study and phase II studies, which evaluated relacorilant in combination with nab-paclitaxel for treating patients with platinum-resistant ovarian cancer.
Data from the same showed that patients who were treated with relacorilant plus nab-paclitaxel experienced improved progression-free and overall survival versus those who received nab-paclitaxel monotherapy, with no need for biomarker selection.
Last month, the FDA accepted the new drug application (NDA) for relacorilant for treating patients with platinum-resistant ovarian cancer. A final decision from the regulatory body is expected on July 11, 2026.
CORT’s Price Performance
Year to date, shares of Corcept have rallied 43.1% compared with the industry’s rise of 7.4%.
Image Source: Zacks Investment Research
CORT's Ongoing Development Activities With Relacorilant
Corcept is also developing relacorilant for treating Cushing’s syndrome.
In December 2024, the company submitted an NDA for relacorilant to the FDA for treating patients with hypercortisolism (Cushing's syndrome). The regulatory body has assigned a Prescription Drug User Fee Act target action date of Dec. 30, 2025.
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.
Notably, Corcept’s sole marketed drug, Korlym (mifepristone), is already approved for treating Cushing's syndrome. The drug generated sales worth $351.6 million in the first half of 2025, up 13.2% year over year.
A potential approval of relacorilant could enable Corcept to reach a broader patient population and lessen its heavy reliance on Korlym for future growth.
CORT's Zacks Rank & Stocks to Consider
Corcept currently carries a Zacks Rank #5 (Strong Sell).
Some better-ranked stocks in the biotech sector are Chemomab Therapeutics (CMMB - Free Report) and ANI Pharmaceuticals (ANIP - Free Report) , each carrying a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
In the past 60 days, estimates for Chemomab Therapeutics’ 2025 loss per share have narrowed from $2.40 to 60 cents. Loss per share estimates for 2026 have narrowed from $2.80 to $1.00 during the same period. CMMB stock has plunged 52.4% year to date.
Chemomab Therapeutics’ earnings beat estimates in three of the trailing four quarters, while meeting the same on the remaining occasion, with the average surprise being 26.25%.
In the past 60 days, estimates for ANI Pharmaceuticals’ 2025 earnings per share have risen from $7.25 to $7.29. During the same period, earnings per share estimates for 2026 have increased from $7.74 to $7.79. Year to date, ANIP’s shares have rallied 60.5%.
ANI Pharmaceuticals’ earnings beat estimates in each of the trailing four quarters, with the average surprise being 22.66%.