CORCEPT THERAPEUTICS (CORT) Company Report

Corcept Therapeutics' shares dropped $7.81 (-17%) on January 30, 2026, after a Reuters report revealed the FDA had warned the company "on several occasions" not to submit its relacorilant drug application.
This decline follows a 50% share price decrease on December 31, 2025, when Corcept received a complete response letter (CRL) from the FDA for relacorilant, citing insufficient evidence for a favorable benefit-risk assessment.
The FDA's corrected CRL, dated January 28, reportedly stated the agency had explicitly told Corcept to "expect significant review issues" and raised serious liver safety concerns.
Shareholder rights law firm Hagens Berman is investigating whether Corcept misled investors about relacorilant's efficacy, commercial prospects, and FDA communications.

3 days ago

Press Release

Corcept Therapeutics Faces Investigation Following FDA Rejection of Relacorilant

CORT

Legal Proceedings

Product Launch

Corcept Therapeutics (CORT) received a Complete Response Letter (CRL) from the FDA on December 31, 2025, for its proposed hypercortisolism treatment, relacorilant, indicating insufficient evidence of effectiveness.
The company's shares cratered 50% on December 31, 2025, after the CRL announcement, and tumbled an additional $7.81 (-17%) on January 30, 2026, following reports that the FDA had warned Corcept on several occasions not to submit the drug application.
Since December 30, 2025, Corcept's market capitalization has crumbled $3.2 billion.
Shareholder rights law firm Hagens Berman is investigating whether Corcept misled investors about relacorilant's efficacy, commercial prospects, and communications with the FDA, which also raised serious liver safety concerns in a corrected CRL dated January 28, 2026.

4 days ago

Press Release

Corcept Therapeutics under investigation by Hagens Berman after FDA warning report

CORT

Legal Proceedings

Profit Warning

Hagens Berman is investigating Corcept Therapeutics (CORT) for allegedly misleading investors regarding its relacorilant drug application and communications with the FDA.
A Reuters report on Jan. 30, 2026, disclosed that the FDA had warned Corcept "on several occasions" not to submit its relacorilant application, which appears to contradict the company's prior public statements.
This report caused Corcept shares to fall, wiping out approximately $3.2 billion in market capitalization since December 2025.
Corcept had previously received a complete response letter (CRL) from the FDA on Dec. 31, 2025, stating the agency could not reach a favorable benefit-risk assessment for relacorilant without additional evidence of effectiveness.

7 days ago

Press Release

Corcept Therapeutics Under Investigation Following FDA Relacorilant CRL

CORT

Legal Proceedings

Product Launch

The Schall Law Firm is investigating Corcept Therapeutics Incorporated (CORT) for potential violations of securities laws, focusing on whether the company issued false or misleading statements.
This investigation follows Corcept's announcement on December 31, 2025, that the FDA issued a Complete Response Letter (CRL) regarding its 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 positive trial data.
Following this news, shares of Corcept fell by more than 50%.

Jan 28, 2026, 3:00 PM

Press Release

Corcept's Phase 3 ROSELLA Study Meets Primary Overall Survival Endpoint

CORT

New Projects/Investments

Corcept's crucial Phase 3 ROSELLA study for relacorilant in patients with platinum-resistant ovarian cancer met its primary overall survival (OS) endpoint.
The study demonstrated a 35 percent reduction in the risk of death, fulfilling both dual primary endpoints (progressievrije en algehele overleving) without requiring biomarker selection or increasing safety concerns.
The New Drug Application (NDA) for relacorilant is currently under review by the U.S. FDA, with a PDUFA action date of July 11, 2026.
A Marketing Authorization Application (MMA) for relacorilant is also being reviewed by the European Medicines Agency (EMA).

Jan 23, 2026, 2:36 AM

Press Release

Corcept's Relacorilant Phase 3 Trial Achieves Primary Endpoint

CORT

New Projects/Investments

Product Launch

Corcept's Phase 3 ROSELLA trial for Relacorilant in platinum-resistant ovarian cancer achieved its primary endpoint of overall survival, demonstrating a 35 percent reduction in the risk of death.
Both primary endpoints, progression-free survival and overall survival, were met without the need for biomarker selection or increased safety concerns.
The New Drug Application (NDA) for Relacorilant is currently under FDA review with a Prescription Drug User Fee Act (PDUFA) date of July 11, 2026.
The Marketing Authorization Application (MAA) for Relacorilant is also being evaluated by the European Medicines Agency (EMA).

Jan 23, 2026, 2:36 AM

Press Release

Corcept Therapeutics' Relacorilant Phase 3 Study Achieves Primary Endpoints

CORT

Product Launch

New Projects/Investments

Revenue Acceleration/Inflection

Corcept Therapeutics announced that its Phase 3 ROSELLA study for Relacorilant in platinum-resistant ovarian cancer achieved its primary endpoint of Overall Survival (OS), demonstrating a 35% reduction in the risk of death.
Patients treated with Relacorilant plus Nab-Paclitaxel experienced a median OS of 16.0 months, compared to 11.9 months for the control group, a 4.1-month difference.
The study also previously met its primary endpoint of Progression-Free Survival (PFS), showing a 30% reduction in the risk of disease progression, with Relacorilant being well-tolerated and effective without biomarker selection.
The New Drug Application (NDA) for Relacorilant is under review by the U.S. FDA, with a PDUFA date of July 11, 2026, and a Marketing Authorization Application (MAA) is also under review by the EMA.

Jan 23, 2026, 2:35 AM

Press Release

Corcept Therapeutics Announces Positive Overall Survival Results from ROSELLA Trial

CORT

Product Launch

New Projects/Investments

Corcept Therapeutics' pivotal Phase 3 ROSELLA trial for relacorilant in patients with platinum-resistant ovarian cancer met its overall survival (OS) primary endpoint, showing a 35 percent reduction in the risk of death.
Patients receiving relacorilant plus nab-paclitaxel achieved a median OS of 16.0 months, compared to 11.9 months for those receiving nab-paclitaxel alone.
The trial had previously met its progression-free survival endpoint, demonstrating a 30 percent reduction in the risk of disease progression.
The New Drug Application (NDA) for relacorilant is under review by the FDA, with a Prescription Drug User Fee Act (PDUFA) target action date of July 11, 2026.

Jan 22, 2026, 1:10 PM

8-K

Corcept Therapeutics Announces Positive Phase 3 ROSELLA Trial Results for Relacorilant

CORT

Product Launch

New Projects/Investments

Corcept Therapeutics' pivotal Phase 3 ROSELLA trial for relacorilant in patients with platinum-resistant ovarian cancer met its overall survival (OS) primary endpoint.
Patients treated with relacorilant plus nab-paclitaxel demonstrated a 35 percent reduction in the risk of death, with a median OS of 16.0 months compared to 11.9 months for nab-paclitaxel alone.
The trial also previously met its primary endpoint of improved progression-free survival, showing a 30 percent reduction in the risk of disease progression.
Relacorilant's New Drug Application (NDA) is under review by the U.S. Food and Drug Administration (FDA) with a Prescription Drug User Fee Act (PDUFA) target action date of July 11, 2026, and its Marketing Authorization Application (MAA) is under review by the European Medicines Agency (EMA).

Jan 22, 2026, 1:00 PM

Press Release

Corcept Therapeutics shares drop following FDA complete response letter for relacorilant

CORT

Legal Proceedings

Guidance Update

Corcept Therapeutics (CORT) shares dropped 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 that additional evidence of effectiveness was required for a favorable benefit-risk assessment, contradicting Corcept's prior assurances of FDA approval by the end of 2025 and projections of $3 billion to $5 billion in annual revenues.
This news resulted in a loss of over $3.6 billion in Corcept's market capitalization in one day.
Hagens Berman has launched an investigation into whether Corcept may have misled investors about relacorilant's efficacy and commercial prospects.