What's Happening?
Corcept Therapeutics has received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding its new drug application for relacorilant, intended for treating hypertension
secondary to hypercortisolism. The FDA's letter indicated that the agency could not reach a favorable benefit-risk assessment without additional evidence of the drug's effectiveness. This announcement led to a significant drop in Corcept's stock price, falling from $70.20 to $34.80 per share, a decline of over 50%. The FDA had previously expressed concerns about the adequacy of Corcept's clinical development program, which were reiterated in a corrected CRL issued on January 28, 2026. This ongoing scrutiny has prompted Kaplan Fox & Kilsheimer LLP to investigate potential securities law violations by Corcept.
Why It's Important?
The FDA's decision and the subsequent stock price drop highlight the critical role regulatory bodies play in the pharmaceutical industry. For investors, the FDA's rejection underscores the risks associated with drug development and approval processes. The investigation by Kaplan Fox could lead to legal challenges for Corcept, potentially affecting its financial stability and investor confidence. This situation also serves as a cautionary tale for other pharmaceutical companies about the importance of transparent communication with regulatory agencies and investors.
What's Next?
Corcept Therapeutics may need to conduct additional clinical trials to gather the necessary evidence to satisfy the FDA's requirements. The outcome of Kaplan Fox's investigation could result in legal actions, which might further impact Corcept's market position and investor relations. Stakeholders will be closely monitoring the company's next steps and any updates from the FDA regarding relacorilant's approval process.
