Corcept Tanks on FDA's CRL to Relacorilant NDA in Hypercortisolism

Corcept Therapeutics CORT announced that the FDA has issued a complete response letter (“CRL”) to its new drug application (“NDA”), seeking approval for its proprietary, selective cortisol modulator, relacorilant, to treat patients with hypercortisolism (Cushing’s syndrome).

Shares of Corcept plunged 50.4% on Dec. 31 following the announcement of the news.

How Does the FDA's CRL for Relacorilant Affect CORT

In December 2024, the company submitted an NDA for relacorilant to the FDA for treating patients with hypercortisolism (Cushing's syndrome). A decision from the regulatory body was expected on Dec. 30, 2025.

Relacorilant is a selective cortisol modulator that binds to the glucocorticoid receptor but not to the body's other hormone receptors.

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.

Per the FDA, even though the GRACE study met its primary endpoint and the GRADIENT study supported the findings, the agency could not determine that relacorilant’s benefits outweigh its risks without additional evidence of effectiveness from Corcept.

It can be inferred that additional studies would now be needed to get more evidence on relacorilant's effectiveness as a treatment for patients with hypertension secondary to hypercortisolism. This, in turn, is likely to delay the potential approval of relacorilant for the given indication, which does not sit well with the investors, resulting in the stock crashing on Dec. 31.

In the past six months, shares of Corcept have plunged 51.8% against the industry’s rise of 3.4%.

CORT's Other Development Activities With Relacorilant

Besides hypercortisolism, Corcept is also developing relacorilant for certain cancer indications.

The FDA accepted an NDA seeking approval for relacorilant in combination with nab-paclitaxel for treating patients with platinum-resistant ovarian cancer in September 2025. A decision from the regulatory body is expected on July 11, 2026.

Corcept recently submitted a marketing authorization application to the European Medicines Agency, seeking approval for relacorilant to treat patients with platinum-resistant ovarian cancer. A decision in Europe is expected by the end of 2026.

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.

Previously, management stated that the BELLA study would help in understanding whether combining relacorilant with two medicines — nab-paclitaxel and RHHBY’s Avastin — offers patients an additional treatment option or not.

We note that a potential approval for relacorilant in Cushing's syndrome could have helped Corcept address a broader patient population and reduce its heavy dependence on the sole-marketed drug, Korlym, for growth. The company’s top line solely comprises product sales from Korlym.

Korlym is approved for treating Cushing's syndrome or endogenous hypercortisolism. In the first nine months of 2025, Korlym recorded sales of $559.3 million, up around 13.4% year over year.

Also, it remains to be seen how the FDA’s CRL for relacorilant in Cushing’s syndrome will impact the upcoming decision in platinum-resistant ovarian cancer.

Corcept Therapeutics Incorporated Price

Corcept Therapeutics Incorporated price | Corcept Therapeutics Incorporated Quote

CORT's Zacks Rank & Stocks to Consider

Corcept currently carries a Zacks Rank #3 (Hold).

Some better-ranked stocks in the biotech sector are CorMedix CRMD and ANI Pharmaceuticals ANIP, both 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 CorMedix’s 2026 earnings per share (EPS) have moved up from $2.49 to $2.88. CRMD stock has increased 0.3% in the past six months.

CorMedix’s earnings beat estimates in each of the trailing four quarters, with the average surprise being 27.04%.

In the past 60 days, estimates for ANI Pharmaceuticals’ 2026 EPS have moved up from $7.81 to $8.08. ANIP stock has rallied 20.9% in the past six months.

ANI Pharmaceuticals’ earnings beat estimates in each of the trailing four quarters, with the average surprise being 21.24%.

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

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