Corcept Therapeutics Faces Regulatory Hurdle and Market Scrutiny

Shares of Corcept Therapeutics have been under significant pressure following a regulatory setback for its drug candidate, relacorilant. The company received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration in late December 2025, triggering a chain of negative market reactions that continue to impact the stock.

The FDA's decision prompted an immediate and severe sell-off. On December 31, 2025, the equity lost more than half its value in a single trading session. Recent trading shows the stock at $34.19, reflecting an intraday decline of 1.56% as of the morning session. The share price remains well below its annual highs, with a 52-week low of $32.99. The previous closing price on January 16 was $34.73.

A summary of critical developments includes:
* Regulatory Hurdle: The FDA's CRL indicated that the current data is insufficient to establish a favorable benefit-risk profile for relacorilant, requesting additional efficacy evidence.
* Legal Investigations: Multiple law firms, including Hagens Berman, DJS Law Group, The Schall Law Firm (with announcements on January 14/15), and Levi & Korsinsky (announcement January 6), have initiated inquiries into potential disclosure violations by the company.
* Analyst Revisions: Several research firms have adjusted their outlooks. Zacks downgraded the stock to a "Strong Sell" and trimmed its Q3 2026 EPS estimate from $0.32 to $0.30. H.C. Wainwright slashed its price target to $90 from $145, while Canaccord Genuity reduced its target to $99 from $140. H.C. Wainwright notably suggested a potential commercial launch delay into Q1 2029.
* Insider Activity: Chief Development Officer William Guyer sold 20,000 shares on January 6 for approximately $703,656, a transaction the company attributed to personal portfolio management.

Should investors sell immediately? Or is it worth buying Corcept Therapeutics?

Path Forward and Strategic Response

In response to the FDA's letter, Corcept intends to request a Type-A meeting with the regulatory agency by the end of the first quarter. This discussion is expected to clarify the specific data requirements needed to resubmit the application for relacorilant, making it a pivotal event for the drug's future timeline.

Investors are now looking ahead to the company's next quarterly earnings report, anticipated around February 18 or 25. This update will likely provide further details on Corcept's financial position and revised corporate strategy in light of the regulatory delay. The convergence of legal scrutiny, analyst downgrades, and a shifted commercial horizon presents a complex challenge for the biopharmaceutical firm as it navigates this period of uncertainty.