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Corcept Therapeutics (CORT) Faces Investor Scrutiny Amid Receipt of FDA Complete Response Letter For Relacorilant, Shares Tank 50% - Hagens Berman

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SAN FRANCISCO, Jan. 6, 2026 /PRNewswire/ -- Investors in Corcept Therapeutics Incorporated (NASDAQ: ...

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AI Summary

Corcept Therapeutics experienced a dramatic 50% share price drop following the FDA's complete response letter for relacorilant, prompting an investigation into potential misrepresentations about the drug. The market wiped out over $3.6 billion in capitalization, significantly impacting investor confidence and raising questions about the company's future prospects.

Trading Thesis

CORT may remain under pressure due to FDA setbacks and potential legal repercussions.

Market-Moving

  • CORT's market cap loss indicates severe investor uncertainty and sentiment shift.
  • FDA's CRL could deter future investments in CORT's drug pipeline.
  • Ongoing investigation may lead to legal consequences, affecting CORT's valuation.
  • Short selling opportunity appears viable as market reacts negatively.
  • Investor sentiment may continue to decline without positive news.

Key Facts

  • CORT share price fell by 50% to around $35 after FDA CRL.
  • The market cap loss was over $3.6 billion.
  • Hagens Berman launched an investigation into possible investor misleading.
  • Relacorilant was expected to generate $3-5 billion in annual revenue.
  • FDA requires additional evidence for relacorilant's efficacy.

Companies Mentioned

  • Corcept Therapeutics (CORT): Facing potential legal issues and investor backlash after FDA setbacks.

Corporate Developments

The announcement falls under Corporate Developments, as it indicates significant setbacks in regulatory approval and investor relations, potentially reshaping perceptions of CORT's future growth and operational viability.

FAQ

Why Very Bearish?

The drastic drop in CORT's share price after the FDA's announcement reflects a clear loss of investor confidence. Historical examples, such as other biotech firms facing similar setbacks, show prolonged negative impacts on stock performance and investor sentiment.

How important is it?

The FDA's complete response letter dramatically alters investor expectations and trust in CORT's future, making it highly relevant for assessing the company's valuation and potential legal ramifications.

Why Short Term?

The immediate implications from the CRL and market reaction suggest a short-term focus, but ongoing investigations could prolong negative sentiment.

Related Companies

Corcept Therapeutics (CORT) Faces Investor Scrutiny Following FDA Setback

On December 31, 2025, investors in Corcept Therapeutics Incorporated (NASDAQ: CORT) experienced a dramatic decline in their investment as the company's stock plummeted by 50%. This sharp decrease came after the company announced it had received a Complete Response Letter (CRL) from the FDA regarding its proposed treatment for patients suffering from hypercortisolism, also known as Cushing's syndrome, specifically the drug relacorilant.

Implications of the Complete Response Letter

The CRL issued by the FDA indicates that the agency was unable to reach a favorable benefit-risk assessment for relacorilant without further evidence of its effectiveness. As a result, investors are questioning whether Corcept may have inaccurately portrayed the drug's potential efficacy and the commercial prospects associated with it.

The immediate market reaction was severe, with shares of CORT decreasing by more than $35, leading to a loss of over $3.6 billion in market capitalization in just one day.

Previous Promises and Investor Confidence

Prior to this announcement, Corcept had consistently communicated its confidence in relacorilant. The company claimed that patients involved in clinical trials "exhibited clinically meaningful improvements in a wide range of hypercortisolism signs and symptoms." Additionally, management expressed optimism that the new drug application for relacorilant was advancing towards a potential approval by the end of 2025.

Corcept's management set ambitious revenue targets, forecasting that the hypercortisolism business could grow from $3 billion to $5 billion in annual revenues within three to five years. These assertions have now come under scrutiny following the FDA's recent communication.

Investigation by Hagens Berman

The fallout from the CRL has prompted national shareholder rights law firm Hagens Berman to initiate an investigation into whether CORT misled investors concerning relacorilant's effectiveness. 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."

Hagens Berman is urging investors who incurred substantial losses in their investments in Corcept to come forward and discuss their rights and options. Interested parties can reach out to the firm either through their website at www.hbsslaw.com/investor-fraud/cort or by calling 844-916-0895.

Whistleblower Opportunities

Individuals with non-public information about Corcept are encouraged to consider providing information that may assist in the investigation. Additionally, whistleblowers may benefit from the SEC Whistleblower program, which offers awards of up to 30% for original information leading to successful recoveries.

About Hagens Berman

Hagens Berman is a prominent plaintiffs' rights complex litigation firm that advocates for corporate accountability. The firm has successfully represented investors, whistleblowers, workers, and consumers, achieving significant legal victories. With over $2.9 billion in recoveries to date, Hagens Berman continues to prioritize the welfare of those harmed by corporate malfeasance.

For more information on their ongoing investigations or to stay updated with the latest news, follow Hagens Berman at @ClassActionLaw.

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