What's Happening?
Kaplan Fox & Kilsheimer LLP has initiated an investigation into Corcept Therapeutics, Inc. for potential securities law violations. This follows the U.S. Food and Drug Administration's (FDA) issuance of a Complete Response Letter (CRL) regarding Corcept's New Drug Application for relacorilant, intended to treat hypertension secondary to hypercortisolism. The FDA's letter indicated that the agency could not make a favorable benefit-risk assessment without additional evidence of effectiveness. This announcement led to a significant drop in Corcept's stock price, which fell over 50% from $70.20 to $34.80 per share on December 31, 2025. Further, a corrected version of the CRL released on January 30, 2026, highlighted the FDA's prior concerns about
the clinical development program's adequacy, causing another stock price decline of over 12%.
Why It's Important?
The investigation by Kaplan Fox is significant as it underscores the potential legal and financial repercussions for Corcept Therapeutics. The FDA's rejection of relacorilant's application not only impacts the company's market valuation but also raises questions about its clinical trial processes and regulatory compliance. Investors who have suffered losses may seek legal recourse, which could lead to costly litigation for Corcept. This situation highlights the critical importance of robust clinical evidence and regulatory alignment in the pharmaceutical industry, where FDA approval is pivotal for market success. The outcome of this investigation could influence investor confidence and the company's future financial health.
What's Next?
As the investigation progresses, Corcept Therapeutics may face increased scrutiny from investors and regulatory bodies. The company will likely need to address the FDA's concerns and potentially redesign its clinical trials to meet regulatory standards. This could involve significant time and financial investment. Additionally, the outcome of Kaplan Fox's investigation could lead to legal actions, affecting the company's operations and stock performance. Stakeholders, including investors and regulatory agencies, will be closely monitoring developments, which could impact Corcept's strategic decisions and market position.
