Corcept Therapeutics (CORT) Shares Fall Again Amid Report FDA Warned Several Times Not to Submit Relacorilant Drug Application – Hagens Berman
SAN FRANCISCO, Jan. 30, 2026 (GLOBE NEWSWIRE) -- The latest adverse development for Corcept Therapeutics (NASDAQ: CORT) concerning its proposed treatment of patients with hypercortisolism (also known as Cushing’s syndrome) – relacorilant – came on January 30, 2026 when Reuters reported that the FDA “warned the company ‘on several occasions’ not to submit its drug application.”
This news sent the price of Corcept shares tumbling $7.81 (-17%) during trading that day.
The move lower comes after investors saw the price of their shares crater 50% on December 31, 2025 after the company announced its receipt of a complete response letter (“CRL”) from the FDA for the therapy.
National shareholder rights law firm Hagens Berman continues to investigate whether Corcept may have misled investors about relacorilant’s efficacy and commercial prospects. The firm urges Corcept investors who suffered significant losses to contact the firm now to discuss their rights.
View our latest video summary of the allegations: youtube.com/watch?v=vMk3jcOV3Ng
Visit: www.hbsslaw.com/investor-fraud/cort
Contact the Firm Now: CORT@hbsslaw.com
844-916-0895
Corcept Therapeutics (CORT) Investigation:
In the past, Corcept has touted relacorilant’s efficacy and commercial prospects. For example, the company has assured investors that patients in its clinical trials “exhibited clinically meaningful improvements in a wide range of hypercortisolism signs and symptoms[.]”
Corcept has also repeatedly assured investors that “[o]ur new drug application for relacorilant is progressing toward approval by the end of” 2025 and “[r]elacorilant’s strong efficacy and safety profile gives us the potential to become the new standard of care for patients with hypercortisolism.”
Critically, Corcept’s management also expressed confidence that “we’re [more] confident than ever that we’re on track to grow our hypercortisolism business from $3 billion to $5 billion in annual revenues in three to five years.”
Investors’ expectations were first dashed on December 31, 2025. That day, Corcept revealed that, in contrast to relacorilant’s progress toward FDA approval by the end of 2025, the company received a CRL which it said indicated the FDA “concluded it could not arrive at a favorable benefit-risk assessment for relacorilant without Corcept providing additional evidence of effectiveness.” HCPLive reported “[u]ltimately, investigators found that loss of blood pressure control was 83% less likely to occur in the relacorilant arm compared to placebo[.]”
Nonetheless, CEO Joseph K. Belanoff, MD, professed “[w]e are surprised and disappointed by this outcome[.]”
Questions about the propriety of the company’s surprise and disappointment as well as statements about its FDA communications arose on January 30, 2026, when Reuters published a bombshell report, “Corcept shares tumble after FDA letter reveals warnings before drug rejection.”
Reuters further reported that the FDA issued a corrected CRL dated January 28 which showed that the agency warned the company “‘on several occasions’” not to submit its relacorilant application. According to the report, the corrected CRL said “the FDA had explicitly told Corcept to ‘expect significant review issues’ if it proceeded with the submission.” In addition, the FDA reportedly raised serious liver safety concerns.
Since December 30, 2025, Corcept investors have seen the market capitalization of the company Corcept crumble $3.2 billion.
“We’ve expanded our focus to include whether Corcept may have misled investors about its FDA communications, in addition to relacorilant’s efficacy and safety. If so, we’re analyzing whether it may have also overstated its hypercortisolism business commercial and growth prospects,” said Reed Kathrein, the Hagens Berman partner leading the firm’s investigation.
If you invested in Corcept and have substantial losses, or have knowledge that may assist the firm’s investigation, submit your losses now »
If you’d like more information and answers to other frequently asked questions about the Corcept case and our investigation, read more »
Whistleblowers: Persons with non-public information regarding Corcept should consider their options to help in the investigation or take advantage of the SEC Whistleblower program. Under the new program, whistleblowers who provide original information may receive rewards totaling up to 30 percent of any successful recovery made by the SEC. For more information, call Reed Kathrein at 844-916-0895 or email CORT@hbssslaw.com.
About Hagens Berman
Hagens Berman is a global plaintiffs’ rights complex litigation firm focusing on corporate accountability. The firm is home to a robust practice and represents investors as well as whistleblowers, workers, consumers and others in cases achieving real results for those harmed by corporate negligence and other wrongdoings. Hagens Berman’s team has secured more than $2.9 billion in this area of law. More about the firm and its successes can be found at hbsslaw.com. Follow the firm for updates and news at @ClassActionLaw.
Contact:
Reed Kathrein, 844-916-0895
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