Levi & Korsinsky LLP
04/07/2026 | Press release | Distributed by Public on 04/07/2026 08:03
Pressure Points at Corcept: Investors Allege FDA Red Flags Were Kept Under Wraps
Corcept told investors relacorilant was the future. A safer, next generation treatment for Cushing's syndrome.
They said the data was powerful. Approval was coming. No impediments to approval.
On October 30, 2024, executives said their Phase Three trials cleared the path for an FDA application.
By December 30, 2024, they announced the application was officially submitted.
Throughout 2025, they doubled down. In May, they said approval was on track by year end. In July and November, they repeated it. Executives told investors they believed relacorilant could generate three to $5 billion in annual revenue within the next 3 to 5 years.
But behind the scenes, the lawsuit claims the FDA had informed the company on several occasions that it should expect significant review issues with the application. Then on December 31, 2025, the truth hit. Then the FDA issued a Complete Response Letter, stating it could not approve the application in its present form without additional evidence of effectiveness. The stock collapsed more than 50% in a single day.
Investors were stunned. Confidence evaporated.
Now, more investors are joining the lawsuit.
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