#United States #San Francisco #FDA #Corcept Therapeutics #Relacorilant

Corcept Therapeutics Under Investor Scrutiny After FDA Letter

In a massive blow to investors, Corcept Therapeutics Incorporated (NASDAQ: CORT) witnessed its stock price tumble by 50% on December 31, 2025. This drastic decline follows the company receiving a complete response letter (CRL) from the FDA regarding its promising treatment relacorilant, aimed at patients with hypercortisolism or Cushing's syndrome. This unexpected turn of events has raised questions about the transparency and communication tactics used by the company leading up to this announcement.

In earlier announcements, Corcept had consistently highlighted relacorilant as a groundbreaking advancement in treating hypercortisolism. The firm's management reassured stakeholders that participants in clinical trials showed significant enhancements in various symptoms associated with the condition and that the new drug application was “on track” for regulatory approval by the end of 2025. Additionally, the company projected revenues from its hypercortisolism business to significantly increase from $3 billion to $5 billion over the next three to five years. The confidence exhibited by Corcept, however, sharply contrasts with the reality revealed in the CRL which the FDA issued late last year.

The essence of the CRL was that the FDA determined there was insufficient evidence to establish a favorable benefit-risk balance for the relacorilant treatment. Reports indicated that while some improvements were noted, the level of evidence was not sufficient to support its efficacy claims comprehensively. In particular, data suggested a notable reduction in blood pressure issues among patients treated with relacorilant compared to those on a placebo; however, the FDA remained unconvinced regarding its overall effectiveness.

The market reaction was immediate and severe. Following the announcement, shares of Corcept plunged more than $35 in value, erasing over $3.6 billion from the company’s market capitalization in a single day. This financial devastation has prompted national shareholder rights law firm, Hagens Berman, to initiate an investigation. The firm is probing whether Corcept may have misrepresented relacorilant's commercial potential and its therapeutic efficacy to investors.

Reed Kathrein, a partner at Hagens Berman, stated, “We’re focused on whether Corcept may have overstated relacorilant’s efficacy and, if so, whether it may have also overstated its hypercortisolism business commercial and growth prospects.” This scrutiny raises concerns not just about the specific fallout related to relacorilant but also about the broader implications for corporate governance and investor relations integrity within the biotech sector.

In light of these developments, Hagens Berman urges investors who experienced significant losses to reach out to them for a consultation. This investigation further indicates a growing sentiment among investors concerning the need for corporate accountability in the biotech industry, especially regarding drug approvals and market performance claims.

For those interested in participating in the investigation or potentially reporting further disclosures, Hagens Berman also reminds individuals that whistleblower protections are in place to reward those who provide critical, non-public information regarding potential misconduct. As they explore this scandal, it marks a critical moment for Corcept and its future in the biotech landscape.

In conclusion, the events concerning Corcept serve as a reminder of the volatility inherent in the biotech sector, where investor expectations can rapidly shift based on regulatory bodies’ assessments. As the industry continues to evolve, maintaining transparency and trust will be vital for companies looking to navigate the complex landscape of drug development and approval.