CORT Files MAA for Relacorilant in Platinum-Resistant Ovarian Cancer

Corcept Therapeutics CORT 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%.

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 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 and ANI Pharmaceuticals ANIP, 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%.

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This article originally published on Zacks Investment Research (zacks.com).

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