Corcept's Treatment Faces FDA Warnings, Shares Plunge
Written by Emily J. Thompson, Senior Investment Analyst
Updated: 1h ago
0mins
Source: Globenewswire
- FDA Warning Impact: On January 30, 2026, the FDA warned Corcept multiple times against submitting its drug application for relacorilant, resulting in a 17% drop in share price and a $3.2 billion market cap loss, indicating serious review issues that could hinder future financing and R&D capabilities.
- Clinical Trial Setback: Corcept received a Complete Response Letter (CRL) from the FDA on December 31, 2025, indicating that the agency could not reach a favorable benefit-risk assessment for relacorilant, with the CEO expressing surprise and disappointment, highlighting a significant setback in drug development that may erode investor confidence.
- Investor Investigation Launched: Hagens Berman is investigating whether Corcept misled investors regarding relacorilant's efficacy and commercial prospects, which, if proven, could lead to legal action, further damaging the company's reputation and impacting shareholder rights.
- Uncertain Market Outlook: Although Corcept previously projected its hypercortisolism business to grow from $3 billion to $5 billion in annual revenues over the next three to five years, the FDA's warnings and the issuance of the CRL have cast doubt on this outlook, potentially necessitating strategic adjustments and loss of market share.
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Analyst Views on CORT
Wall Street analysts forecast CORT stock price to rise over the next 12 months. According to Wall Street analysts, the average 1-year price target for CORT is 91.00 USD with a low forecast of 50.00 USD and a high forecast of 121.00 USD. However, analyst price targets are subjective and often lag stock prices, so investors should focus on the objective reasons behind analyst rating changes, which better reflect the company's fundamentals.
6 Analyst Rating
4 Buy
1 Hold
1 Sell
Moderate Buy
Current: 44.610
Low
50.00
Averages
91.00
High
121.00
Current: 44.610
Low
50.00
Averages
91.00
High
121.00
About CORT
Corcept Therapeutics Incorporated is a commercial-stage company. The Company is engaged in the discovery and development of medications to treat severe endocrinologic, oncologic, metabolic and neurologic disorders by modulating the effects of the hormone cortisol. The Company operates through the discovery, development and commercialization of the pharmaceutical products segment. The Company has marketed Korlym (mifepristone) in the United States for the treatment of patients suffering from Cushings syndrome. The Company’s portfolio of selective cortisol modulators consists of four series totaling approximately 1,000 compounds. Its portfolio of selective cortisol modulators consists of relacorilant, dazucorilant and miricorilant. Korlyms active ingredient, mifepristone, reduces the binding of excess cortisol to the GR, it can modulate the effects of abnormal levels and release patterns of cortisol without compromising cortisols healthy functions and rhythms.
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
Corcept Therapeutics Faces FDA Rejection of New Drug Application
- FDA Rejection: Corcept Therapeutics' New Drug Application for the hormonal disorder therapy relacorilant was rejected by the FDA, leading to a nearly 16% drop in premarket trading, indicating market concerns about the drug's prospects.
- Lack of Data Support: The FDA's updated Complete Response Letter indicated that it could not determine a favorable benefit-risk assessment for the drug without additional data, reflecting the agency's stringent requirements for drug safety and efficacy.
- Indication Context: The NDA aimed to provide treatment options for patients with high blood pressure related to hormonal disorders (Cushing's syndrome), and the FDA's rejection signifies a significant setback for Corcept in this market.
- Market Reaction Analysis: The FDA's decision not only impacts investor confidence but may also delay the company's market entry in the hormonal disorder space, further affecting its future revenue expectations and strategic planning.
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Corcept's Treatment Faces FDA Warnings, Shares Plunge
- FDA Warning Impact: On January 30, 2026, the FDA warned Corcept multiple times against submitting its drug application for relacorilant, resulting in a 17% drop in share price and a $3.2 billion market cap loss, indicating serious review issues that could hinder future financing and R&D capabilities.
- Clinical Trial Setback: Corcept received a Complete Response Letter (CRL) from the FDA on December 31, 2025, indicating that the agency could not reach a favorable benefit-risk assessment for relacorilant, with the CEO expressing surprise and disappointment, highlighting a significant setback in drug development that may erode investor confidence.
- Investor Investigation Launched: Hagens Berman is investigating whether Corcept misled investors regarding relacorilant's efficacy and commercial prospects, which, if proven, could lead to legal action, further damaging the company's reputation and impacting shareholder rights.
- Uncertain Market Outlook: Although Corcept previously projected its hypercortisolism business to grow from $3 billion to $5 billion in annual revenues over the next three to five years, the FDA's warnings and the issuance of the CRL have cast doubt on this outlook, potentially necessitating strategic adjustments and loss of market share.
Continue Reading