FDA Accepts Corcept's NDA for Relacorilant in Ovarian Cancer

Corcept Therapeutics CORT announced that the FDA has accepted the new drug application (NDA) seeking approval for its lead pipeline candidate, relacorilant, for treating patients with platinum-resistant ovarian cancer.

With the FDA accepting the NDA for review, a decision from the regulatory body is expected on July 11, 2026.

The NDA 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. In July 2025, the company submitted the NDA for relacorilant.

Earlier this year, the company announced that the ROSELLA study met its primary endpoint of improved progression-free survival, as assessed by a blinded independent central review (PFS-BICR). Back then, management stated that data from the ROSELLA study suggested that the combination 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 42.1% compared with the industry’s rise of 12.9%.

CORT’s Relacorilant Nearing Potential FDA Nod in Cushing's Syndrome

In December 2024, the company submitted a new drug application (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.

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.

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.

The company is also evaluating relacorilant plus Xtandi (enzalutamide) in a mid-stage study for treating patients with early-stage prostate cancer.

We note that CORT’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 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 Zacks Rank & Stocks to Consider

Corcept currently carries a Zacks Rank #4 (Sell).

Some better-ranked stocks in the biotech sector are Akero Therapeutics AKRO and Adaptive Biotechnologies ADPT, 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 Akero Therapeutics’ 2025 loss per share have narrowed from $3.93 to $3.82. Loss per share estimates for 2026 have narrowed from $4.27 to $4.12 during the same period. AKRO stock has surged 55.5% year to date.

Akero Therapeutics’ earnings beat estimates in three of the trailing four quarters while missing the same on the remaining occasion, the average surprise being 49.24%.

In the past 60 days, estimates for Adaptive Biotechnologies’ 2025 loss per share have narrowed from 87 cents to 71 cents. Loss per share estimates for 2026 have narrowed from 65 cents to 60 cents during the same period. ADPT stock has soared 107.1% year to date.

Adaptive Biotechnologies’ earnings beat estimates in each of the trailing four quarters, the average surprise being 23.99%.

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

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