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CHMP Backs CORT's Lifyorli Combo in Platinum-Resistant Ovarian Cancer
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Key Takeaways
CORT wins positive CHMP opinion for Lifyorli plus nab-paclitaxel in platinum-resistant ovarian cancer.
Corcept's Lifyorli generated $47.6 million in Q2 2026, its first quarter of commercial availability.
CORT is studying relacorilant in other solid tumors, including prostate and pancreatic cancers.
Corcept Therapeutics (CORT - Free Report) announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending approval of Lifyorli (relacorilant) in combination with nab-paclitaxel for the treatment of patients with platinum-resistant ovarian cancer.
The recommendation will now be reviewed by the European Commission (EC). A final decision from the regulatory body is expected in the fourth quarter of 2026.
The CHMP’s opinion was based on positive data from a phase II and the pivotal phase III ROSELLA study, which evaluated the combination of Lifyorli plus nab-paclitaxel in the given patient population. Data from the study showed that treatment with Lifyorli combined with nab-paclitaxel led to improved progression-free and overall survival compared to patients who received nab-paclitaxel alone.
The safety profile of Lifyorli plus nab-paclitaxel was similar to that of nab-paclitaxel monotherapy in the studies.
The FDA approved Lifyorli in combination with nab-paclitaxel for the treatment of adult patients with platinum-resistant ovarian cancer in March 2026.
Lifyorli generated $47.6 million in the second quarter of 2026, reflecting its first quarter of commercial availability.
CORT’s Price Performance
Year to date, shares of Corcept have surged 216.9% against the industry’s 2.9% decline.
Image Source: Zacks Investment Research
CORT’s Other Development Activities With Relacorilant
Relacorilant, in combination with other anticancer therapies, is also being studied in other solid tumors, including platinum-sensitive ovarian, prostate, endometrial, cervical and pancreatic cancers.
The phase II BELLA study (part A) is evaluating relacorilant plus nab-paclitaxel and Roche’s (RHHBY - Free Report) Avastin (bevacizumab) for treating patients with platinum-resistant ovarian cancer.
The BELLA study is designed to understand whether combining relacorilant with two medicines — nab-paclitaxel and RHHBY’s Avastin — offers patients an additional treatment option or not.
Importantly, Corcept is also developing relacorilant, a selective glucocorticoid receptor antagonist for treating Cushing's syndrome. The company resubmitted the new drug application (NDA) for relacorilant for the treatment of patients with hypercortisolism (Cushing's syndrome) to the FDA in June 2026. The FDA accepted the application and assigned a target action date of Dec. 17, 2026.
The successful development and commercialization of relacorilant for additional indications will be an added boost to the company.
Over the past 60 days, estimates for Repligen’s 2026 earnings per share have risen from $1.99 to $2.06, while estimates for 2027 have increased from $2.57 to $2.61 during the same time. RGEN’s shares have risen 8% year to date.
Repligen’s earnings beat estimates in each of the trailing four quarters, with the average surprise being 16.80%.
Over the past 60 days, estimates for Precigen’s 2026 bottom line have moved from a loss of 2 cents per share to earnings of 25 cents. Earnings estimates for 2027 have increased from 25 cents to 86 cents during the same time. PGEN’s shares have rallied 86.2% year to date.
Precigen’s earnings beat estimates in three of the trailing four quarters, while missing the same on the remaining occasion, with the average surprise being 108.96%.
View the Zacks #1 Rank List
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CHMP Backs CORT's Lifyorli Combo in Platinum-Resistant Ovarian Cancer
Key Takeaways
Corcept Therapeutics (CORT - Free Report) announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending approval of Lifyorli (relacorilant) in combination with nab-paclitaxel for the treatment of patients with platinum-resistant ovarian cancer.
The recommendation will now be reviewed by the European Commission (EC). A final decision from the regulatory body is expected in the fourth quarter of 2026.
The CHMP’s opinion was based on positive data from a phase II and the pivotal phase III ROSELLA study, which evaluated the combination of Lifyorli plus nab-paclitaxel in the given patient population. Data from the study showed that treatment with Lifyorli combined with nab-paclitaxel led to improved progression-free and overall survival compared to patients who received nab-paclitaxel alone.
The safety profile of Lifyorli plus nab-paclitaxel was similar to that of nab-paclitaxel monotherapy in the studies.
The FDA approved Lifyorli in combination with nab-paclitaxel for the treatment of adult patients with platinum-resistant ovarian cancer in March 2026.
Lifyorli generated $47.6 million in the second quarter of 2026, reflecting its first quarter of commercial availability.
CORT’s Price Performance
Year to date, shares of Corcept have surged 216.9% against the industry’s 2.9% decline.
Image Source: Zacks Investment Research
CORT’s Other Development Activities With Relacorilant
Relacorilant, in combination with other anticancer therapies, is also being studied in other solid tumors, including platinum-sensitive ovarian, prostate, endometrial, cervical and pancreatic cancers.
The phase II BELLA study (part A) is evaluating relacorilant plus nab-paclitaxel and Roche’s (RHHBY - Free Report) Avastin (bevacizumab) for treating patients with platinum-resistant ovarian cancer.
The BELLA study is designed to understand whether combining relacorilant with two medicines — nab-paclitaxel and RHHBY’s Avastin — offers patients an additional treatment option or not.
Importantly, Corcept is also developing relacorilant, a selective glucocorticoid receptor antagonist for treating Cushing's syndrome. The company resubmitted the new drug application (NDA) for relacorilant for the treatment of patients with hypercortisolism (Cushing's syndrome) to the FDA in June 2026. The FDA accepted the application and assigned a target action date of Dec. 17, 2026.
The successful development and commercialization of relacorilant for additional indications will be an added boost to the company.
CORT’s Zacks Rank & Stocks to Consider
Corcept currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks in the biotech sector are Repligen (RGEN - Free Report) and Precigen (PGEN - Free Report) , each sporting a Zacks Rank #1 (Strong Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.
Over the past 60 days, estimates for Repligen’s 2026 earnings per share have risen from $1.99 to $2.06, while estimates for 2027 have increased from $2.57 to $2.61 during the same time. RGEN’s shares have risen 8% year to date.
Repligen’s earnings beat estimates in each of the trailing four quarters, with the average surprise being 16.80%.
Over the past 60 days, estimates for Precigen’s 2026 bottom line have moved from a loss of 2 cents per share to earnings of 25 cents. Earnings estimates for 2027 have increased from 25 cents to 86 cents during the same time. PGEN’s shares have rallied 86.2% year to date.
Precigen’s earnings beat estimates in three of the trailing four quarters, while missing the same on the remaining occasion, with the average surprise being 108.96%.