What Happened?
Shares of biopharma company Corcept Therapeutics (NASDAQ: CORT) fell 51.4% in the afternoon session after the U.S. Food and Drug Administration (FDA) issued a Complete Response Letter (CRL) rejecting the company's New Drug Application for relacorilant.
The drug, which was being developed to treat hypertension in patients with hypercortisolism, failed to secure approval because the FDA concluded the submitted data was insufficient. Specifically, regulators noted they could not finalize a favorable benefit-risk assessment without additional evidence regarding the drug's effectiveness. This rejection blindsided investors who had widely expected approval based on earlier phase 3 trial results, triggering a massive sell-off as the market repriced the stock to exclude immediate revenue from this key pipeline asset.
The dramatic plunge underscores the high stakes surrounding Corcept's effort to diversify beyond Korlym. Relacorilant was viewed as a critical successor that would offer patients a safer, more selective treatment option with fewer side effects. By issuing the CRL, the FDA has effectively paused Corcept's growth narrative, raising fears that the company may need to conduct another costly and time-consuming clinical trial.
Management stated they intend to request a meeting with the FDA immediately to clarify the deficiencies, but the uncertainty of the path forward has fundamentally shaken investor confidence in the company's near-term future.
The shares closed the day at $34.83, down 50.4% from previous close.
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What Is The Market Telling Us
Corcept’s shares are very volatile and have had 25 moves greater than 5% over the last year. But moves this big are rare even for Corcept and indicate this news significantly impacted the market’s perception of the business.
The previous big move we wrote about was 8 days ago when the stock dropped 4.7% on the news that investor anxiety mounted ahead of a key U.S. Food and Drug Administration (FDA) decision for its drug candidate, relacorilant. The drug was under review, with a target decision date of December 30, 2025. An unfavorable outcome would have posed a significant risk to Corcept's valuation because the company had no other drugs expected to reach approval in the near future. The application for relacorilant was supported by data from two late-stage trials. While one trial, known as GRACE, met its primary goal, the other trial, GRADIENT, did not. The failure of the GRADIENT trial raised the risk that the FDA could issue a Complete Response Letter, effectively rejecting the application.
Corcept is down 30.4% since the beginning of the year, and at $34.77 per share, it is trading 69.6% below its 52-week high of $114.22 from March 2025. Investors who bought $1,000 worth of Corcept’s shares 5 years ago would now be looking at an investment worth $1,329.
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