CORCEPT THERAPEUTICS (CORT) Company Report

The Schall Law Firm is investigating Corcept Therapeutics for potential violations of securities laws, focusing on whether the company issued false or misleading statements or failed to disclose pertinent information to investors.
This investigation follows Corcept's announcement on December 31, 2025, that the FDA issued a Complete Response Letter (CRL) regarding the New Drug Application (NDA) for relacorilant.
The FDA concluded it could not achieve a favorable benefit-risk assessment for relacorilant without additional evidence of effectiveness, despite acknowledging the pivotal GRACE trial met its primary endpoint and the GRADIENT trial provided confirmatory evidence.
Following this news, shares of Corcept fell by more than 50%.

3 days ago

Press Release

Corcept Therapeutics Investigated Following FDA Relacorilant Decision

CORT

Legal Proceedings

Profit Warning

The DJS Law Group is investigating Corcept Therapeutics Incorporated (NASDAQ: CORT) on behalf of investors for potential violations of securities laws, specifically regarding misleading statements or undisclosed information.
This investigation stems from Corcept's announcement on December 31, 2026, that the FDA issued a Complete Response Letter (CRL) for the New Drug Application (NDA) of relacorilant.
The FDA concluded it could not achieve a favorable benefit-risk assessment for relacorilant without additional evidence of effectiveness, despite acknowledging that the pivotal GRACE trial met its primary endpoint and the GRADIENT trial provided confirmatory evidence.
Following this news, Corcept's shares fell by more than half.

3 days ago

Press Release

Corcept Therapeutics Receives FDA Complete Response Letter for Relacorilant, Shares Drop 50%

CORT

Legal Proceedings

Profit Warning

On December 31, 2025, Corcept Therapeutics (CORT) received a Complete Response Letter (CRL) from the FDA for relacorilant, its proposed treatment for hypercortisolism, as the FDA concluded it required additional evidence of effectiveness.
Following this news, Corcept's share price cratered 50% on December 31, 2025, resulting in a loss of over $3.6 billion in market capitalization.
National shareholder rights law firm Hagens Berman has commenced an investigation into whether Corcept may have misled investors regarding relacorilant's efficacy and commercial prospects, given prior assurances of its progress toward FDA approval and projections of $3 billion to $5 billion in annual revenues.

4 days ago

Press Release

Corcept Therapeutics (CORT) Shares Decline Following FDA Complete Response Letter for Relacorilant

CORT

Legal Proceedings

Product Launch

Demand Weakening

Corcept Therapeutics (CORT) shares cratered 50% on December 31, 2025, after the company received a Complete Response Letter (CRL) from the FDA for its proposed hypercortisolism treatment, relacorilant.
The FDA's CRL indicated it could not arrive at a favorable benefit-risk assessment for relacorilant without additional evidence of effectiveness.
Shareholder rights law firm Hagens Berman has commenced an investigation into whether Corcept may have misled investors about relacorilant’s efficacy and commercial prospects, which the company had previously projected to generate $3 billion to $5 billion in annual revenues.

Jan 7, 2026, 10:58 PM

Press Release

Corcept Therapeutics Shares Plummet 50% After FDA Issues Complete Response Letter for Relacorilant

CORT

Product Launch

Legal Proceedings

Corcept Therapeutics (CORT) shares fell 50% on December 31, 2025, after receiving a complete response letter (CRL) from the FDA for its proposed hypercortisolism treatment, relacorilant.
The FDA's CRL indicated that a favorable benefit-risk assessment for relacorilant could not be reached without additional evidence of effectiveness.
This news resulted in a loss of over $3.6 billion in Corcept's market capitalization.
Shareholder rights law firm Hagens Berman has launched an investigation into whether Corcept may have misled investors regarding relacorilant's efficacy and commercial prospects.

Jan 6, 2026, 5:01 PM

Press Release

Corcept Therapeutics Receives FDA Complete Response Letter for Relacorilant NDA

CORT

Product Launch

Corcept Therapeutics (CORT) announced on December 31, 2025, that the U.S. Food and Drug Administration (FDA) issued a Complete Response Letter (CRL) for the New Drug Application (NDA) of relacorilant as a treatment for hypertension secondary to hypercortisolism.
The FDA acknowledged that Corcept's pivotal GRACE trial met its primary endpoint and the GRADIENT trial provided confirmatory evidence, but concluded it could not approve relacorilant without additional evidence of effectiveness.
Corcept's CEO expressed surprise and disappointment and stated the company will meet with the FDA to discuss the path forward.
Relacorilant is also under FDA review for platinum-resistant ovarian cancer with a PDUFA date of July 11, 2026, and a Marketing Authorization Application (MAA) has been submitted to the European Medicines Agency (EMA) for the same indication.

Dec 31, 2025, 7:51 PM

8-K

Corcept Therapeutics Receives Complete Response Letter from FDA for Relacorilant

CORT

Product Launch

New Projects/Investments

Corcept Therapeutics (CORT) received a Complete Response Letter (CRL) from the FDA for its New Drug Application (NDA) for relacorilant as a treatment for patients with hypertension secondary to hypercortisolism.
The FDA concluded it could not achieve a favorable benefit-risk assessment without additional evidence of effectiveness, despite acknowledging that the GRACE trial met its primary endpoint and the GRADIENT trial provided confirmatory evidence.
Corcept's CEO, Joseph K. Belanoff, expressed surprise and disappointment and stated the company will meet with the FDA to discuss the path forward.
Separately, the FDA has assigned a Prescription Drug User Fee Act (PDUFA) date of July 11, 2026, for relacorilant as a treatment for patients with platinum-resistant ovarian cancer, and Corcept has also submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for this indication.

Dec 31, 2025, 1:00 PM

Press Release

Corcept Therapeutics Shares Plunge Ahead of FDA Decision on Relacorilant

CORT

Product Launch

Executive Compensation

Corcept Therapeutics shares plunged by 8% to over 12%, falling below its 200-day moving average of $73.97, due to investor anxiety ahead of the FDA's PDUFA target action date of December 30, 2025, for its relacorilant candidate.
Despite the stock volatility, Corcept maintains strong fundamentals, including a market capitalization of approximately $7.75 billion, revenue of about $741.17 million, 98.19% gross margins, a 3.14 current ratio, and 0.01 debt-to-equity.
CEO Joseph Belanoff exercised 550,000 options and Chief Business Officer Gary Charles Robb exercised 145,000 options on December 24, with portions withheld for taxes and costs.
Additionally, 12 other insider transactions involved the sale of 201,200 shares in the past three months, which may contribute to investor caution.

Dec 30, 2025, 6:10 PM

Bloomberg

Corcept Therapeutics Reports Q3 2025 Results and Updates Guidance

CORT

Earnings

Guidance Update

Product Launch

Corcept Therapeutics reported Q3 2025 revenue of $207.6 million and net income of $19.7 million, with $524 million in cash and investments as of September 30th, 2025.
The company updated its 2025 revenue guidance to $800-$850 million.
Key PDUFA dates for relacorilant include December 30, 2025, for hypercortisolism and July 11, 2026, for platinum-resistant ovarian cancer.
Corcept is awaiting a decision in its patent litigation against Teva Pharmaceuticals, which could prevent Teva from marketing a generic Korlym until 2037 if Corcept wins.
The company is expanding its pharmacy network, transitioning to a new primary vendor in Q4 2025 and planning to add more in early 2026, anticipating $3-$5 billion in annual revenue from relacorilant in hypercortisolism alone within three to five years.

Nov 4, 2025, 10:00 PM

Transcript

Corcept Therapeutics Reports Q3 2025 Financial Results and Updates 2025 Revenue Guidance

CORT

Earnings

Guidance Update

Product Launch

Corcept Therapeutics reported Q3 2025 revenue of $207.6 million and net income of $19.7 million, with cash and investments totaling $524 million as of September 30, 2025.
The company modified its 2025 revenue guidance to $800 million-$850 million.
Key regulatory milestones include PDUFA dates for Relacorilant for hypercortisolism on December 30, 2025, and for platinum-resistant ovarian cancer on July 11, 2026.
Operational updates include a 42.5% increase in Korlym tablet shipments compared to the prior year period, a transition to a new pharmacy in Q4 2025 to address capacity constraints, and plans to add more pharmacies in early 2026.
The company expects R&D expenditures in 2026 to be similar to 2025, while SG&A expenses are projected to increase due to investments for Relacorilant launches.