Corcept Therapeutics Faces FDA Setback on Drug Application
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Jan 30 2026
0mins
Should l Buy CORT?
Source: Globenewswire
Corcept Therapeutics' stock fell by 10.69% as it crossed below the 5-day SMA, reflecting investor concerns following the FDA's rejection of its New Drug Application for relacorilant.
The FDA issued a Complete Response Letter on December 31, 2025, requesting additional evidence for the relacorilant application, despite the GRACE trial meeting its primary endpoint. This setback has led to significant legal investigations by firms like Block & Leviton and Bernstein Liebhard LLP, focusing on potential securities violations and encouraging affected investors to explore their legal options.
The implications of this FDA rejection are severe, as it not only undermines investor confidence but also delays Corcept's entry into the hormonal disorder treatment market, potentially impacting future revenue and strategic planning.
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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: 38.360
Low
50.00
Averages
91.00
High
121.00
Current: 38.360
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 Faces Investor Lawsuit Investigation
- Legal Investigation Launched: Bragar Eagel & Squire, P.C. is investigating Corcept Therapeutics for potential violations of federal securities laws, which may impact investor rights.
- Negative FDA Response: On December 31, 2025, Corcept announced that the FDA issued a Complete Response Letter for relacorilant's New Drug Application, requiring additional evidence of effectiveness, leading to a significant stock price drop.
- Stock Price Plummet: Following the FDA announcement, Corcept's stock price fell by $35.40, a decline of 50.42%, closing at $34.80 per share, indicating market concerns about the company's future prospects.
- Investor Rights Affected: Affected investors are encouraged to contact the law firm to discuss their legal rights and potential claims, highlighting the company's exposure to possible legal liabilities.
See More
Corcept's Treatment Faces FDA Warning, Shares Plummet
- FDA Warning Impact: On January 30, the FDA warned Corcept that it had been told multiple times not to submit its relacorilant drug application, resulting in a 17% drop in share price that day and a $3.2 billion loss in market capitalization, indicating severe investor confidence issues due to FDA scrutiny.
- Poor Clinical Trial Results: Despite Corcept's claims of significant efficacy for relacorilant in clinical trials, the FDA's complete response letter (CRL) highlighted a lack of evidence for effectiveness, with the CEO expressing surprise and disappointment, reflecting a major setback in the company's drug development efforts.
- Investor Confidence Shaken: Since December 31, 2025, Corcept's stock has plummeted by 50%, which not only affects the company's market performance but has also prompted investigations by shareholder rights law firms, potentially involving legal risks for misleading investors, further exacerbating market uncertainty.
- Business Prospects Diminished: Corcept had projected its hypercortisolism business to grow from $3 billion to $5 billion in annual revenues over the next three to five years, but the FDA's warnings and the issuance of the CRL have made this target increasingly elusive, likely necessitating strategic adjustments and resource reallocation within the company.
See More
Corcept Therapeutics Faces Investigation After FDA Rejection
- FDA Rejection: On December 31, 2025, Corcept Therapeutics announced that the FDA issued a Complete Response Letter rejecting its New Drug Application for relacorilant to treat hypertension secondary to hypercortisolism, which left the company feeling 'surprised and disappointed.'
- Stock Price Plunge: This news caused Corcept's stock price to fall by $35.40, or 50.42%, closing at $34.80 per share on December 31, 2025, severely impacting investor confidence.
- Updated Response Letter: On January 29, 2026, the FDA published an updated Complete Response Letter indicating concerns about the adequacy of Corcept's clinical development program, suggesting significant review issues if the application were submitted.
- Further Decline: Following this news, Corcept's stock price dropped another $4.71, or 10.6%, closing at $39.87 per share on January 30, 2026, exacerbating investor losses.
See More
Pomerantz LLP Investigates Corcept for Securities Fraud
- Investigation Launched: Pomerantz LLP is investigating whether Corcept Therapeutics has engaged in securities fraud or other unlawful business practices, aiming to protect investor rights and pursue legal remedies.
- FDA Response: On December 31, 2025, Corcept announced that the FDA issued a Complete Response Letter for relacorilant's New Drug Application, stating that while the GRACE trial met its primary endpoint, additional evidence of effectiveness is required.
- Stock Price Plunge: Following the FDA announcement, Corcept's stock price fell by $35.40, a decline of 50.42%, closing at $34.80 per share, reflecting market pessimism regarding the company's prospects.
- Legal Background: Pomerantz LLP is a renowned securities class action law firm with over 85 years of experience, focusing on advocating for victims of securities fraud and has historically recovered multimillion-dollar damages for class members.
See More
Corcept's Treatment Faces FDA Warning, Shares Plummet
- FDA Warning Impact: On January 30, the FDA warned Corcept that it had been advised multiple times not to submit its drug application for relacorilant, resulting in a 17% drop in share price that day, equating to a $3.2 billion loss in market capitalization, indicating severe investor confidence issues due to regulatory scrutiny.
- Poor Clinical Trial Results: Despite Corcept's claims of relacorilant's efficacy in clinical trials, the FDA's complete response letter (CRL) indicated a lack of evidence for effectiveness, leading to a 50% stock price drop on December 31, 2025, reflecting market skepticism about the drug's commercial viability.
- Investor Confidence Eroded: Hagens Berman law firm is investigating whether Corcept misled investors regarding FDA communications and relacorilant's efficacy, suggesting potential legal risks that further undermine investor confidence in the company.
- Uncertain Future Outlook: Corcept had projected its hypercortisolism business to grow from $3 billion to $5 billion in annual revenues over the next three to five years, but the FDA's warnings and CRL have cast significant doubt on this target, potentially impacting the company's long-term strategy and market positioning.
See More
DJS Law Group Investigates Corcept Securities Violations
- Investigation Background: DJS Law Group is investigating potential securities violations by Corcept Therapeutics, focusing on whether the company made misleading statements or failed to disclose critical information, which may have led to investor losses.
- FDA Response: On December 31, 2026, Corcept revealed that the FDA issued a Complete Response Letter regarding the New Drug Application for relacorilant, indicating that while the GRACE trial met its primary endpoint, the FDA required additional evidence of effectiveness, highlighting regulatory hurdles.
- Stock Price Impact: Following the FDA announcement, Corcept's shares plummeted by over 50%, reflecting a pessimistic market sentiment regarding the company's future prospects, which could undermine investor confidence.
- Legal Service Commitment: DJS Law Group emphasizes its focus on enhancing investor returns through balanced counseling and aggressive advocacy, showcasing its expertise in securities class actions and corporate governance litigation to support affected investors.
See More
Corcept Faces Investor Lawsuit Investigation
- Legal Investigation Launched: Bragar Eagel & Squire, P.C. is investigating Corcept Therapeutics for potential violations of federal securities laws, which may impact investor rights.
- Negative FDA Response: On December 31, 2025, Corcept announced that the FDA issued a Complete Response Letter for relacorilant's New Drug Application, requiring additional evidence of effectiveness, leading to a significant stock price drop.
- Stock Price Plummet: Following the FDA announcement, Corcept's stock price fell by $35.40, a decline of 50.42%, closing at $34.80 per share, indicating market concerns about the company's future prospects.
- Investor Rights Affected: Affected investors are encouraged to contact the law firm to discuss their legal rights and potential claims, highlighting the company's exposure to possible legal liabilities.
See More
Corcept's Treatment Faces FDA Warning, Shares Plummet
- FDA Warning Impact: On January 30, the FDA warned Corcept that it had been told multiple times not to submit its relacorilant drug application, resulting in a 17% drop in share price that day and a $3.2 billion loss in market capitalization, indicating severe investor confidence issues due to FDA scrutiny.
- Poor Clinical Trial Results: Despite Corcept's claims of significant efficacy for relacorilant in clinical trials, the FDA's complete response letter (CRL) highlighted a lack of evidence for effectiveness, with the CEO expressing surprise and disappointment, reflecting a major setback in the company's drug development efforts.
- Investor Confidence Shaken: Since December 31, 2025, Corcept's stock has plummeted by 50%, which not only affects the company's market performance but has also prompted investigations by shareholder rights law firms, potentially involving legal risks for misleading investors, further exacerbating market uncertainty.
- Business Prospects Diminished: Corcept had projected its hypercortisolism business to grow from $3 billion to $5 billion in annual revenues over the next three to five years, but the FDA's warnings and the issuance of the CRL have made this target increasingly elusive, likely necessitating strategic adjustments and resource reallocation within the company.
See More
Corcept Therapeutics Faces Investigation After FDA Rejection
- FDA Rejection: On December 31, 2025, Corcept Therapeutics announced that the FDA issued a Complete Response Letter rejecting its New Drug Application for relacorilant to treat hypertension secondary to hypercortisolism, which left the company feeling 'surprised and disappointed.'
- Stock Price Plunge: This news caused Corcept's stock price to fall by $35.40, or 50.42%, closing at $34.80 per share on December 31, 2025, severely impacting investor confidence.
- Updated Response Letter: On January 29, 2026, the FDA published an updated Complete Response Letter indicating concerns about the adequacy of Corcept's clinical development program, suggesting significant review issues if the application were submitted.
- Further Decline: Following this news, Corcept's stock price dropped another $4.71, or 10.6%, closing at $39.87 per share on January 30, 2026, exacerbating investor losses.
See More
Pomerantz LLP Investigates Corcept for Securities Fraud
- Investigation Launched: Pomerantz LLP is investigating whether Corcept Therapeutics has engaged in securities fraud or other unlawful business practices, aiming to protect investor rights and pursue legal remedies.
- FDA Response: On December 31, 2025, Corcept announced that the FDA issued a Complete Response Letter for relacorilant's New Drug Application, stating that while the GRACE trial met its primary endpoint, additional evidence of effectiveness is required.
- Stock Price Plunge: Following the FDA announcement, Corcept's stock price fell by $35.40, a decline of 50.42%, closing at $34.80 per share, reflecting market pessimism regarding the company's prospects.
- Legal Background: Pomerantz LLP is a renowned securities class action law firm with over 85 years of experience, focusing on advocating for victims of securities fraud and has historically recovered multimillion-dollar damages for class members.
See More
Corcept's Treatment Faces FDA Warning, Shares Plummet
- FDA Warning Impact: On January 30, the FDA warned Corcept that it had been advised multiple times not to submit its drug application for relacorilant, resulting in a 17% drop in share price that day, equating to a $3.2 billion loss in market capitalization, indicating severe investor confidence issues due to regulatory scrutiny.
- Poor Clinical Trial Results: Despite Corcept's claims of relacorilant's efficacy in clinical trials, the FDA's complete response letter (CRL) indicated a lack of evidence for effectiveness, leading to a 50% stock price drop on December 31, 2025, reflecting market skepticism about the drug's commercial viability.
- Investor Confidence Eroded: Hagens Berman law firm is investigating whether Corcept misled investors regarding FDA communications and relacorilant's efficacy, suggesting potential legal risks that further undermine investor confidence in the company.
- Uncertain Future Outlook: Corcept had projected its hypercortisolism business to grow from $3 billion to $5 billion in annual revenues over the next three to five years, but the FDA's warnings and CRL have cast significant doubt on this target, potentially impacting the company's long-term strategy and market positioning.
See More
DJS Law Group Investigates Corcept Securities Violations
- Investigation Background: DJS Law Group is investigating potential securities violations by Corcept Therapeutics, focusing on whether the company made misleading statements or failed to disclose critical information, which may have led to investor losses.
- FDA Response: On December 31, 2026, Corcept revealed that the FDA issued a Complete Response Letter regarding the New Drug Application for relacorilant, indicating that while the GRACE trial met its primary endpoint, the FDA required additional evidence of effectiveness, highlighting regulatory hurdles.
- Stock Price Impact: Following the FDA announcement, Corcept's shares plummeted by over 50%, reflecting a pessimistic market sentiment regarding the company's future prospects, which could undermine investor confidence.
- Legal Service Commitment: DJS Law Group emphasizes its focus on enhancing investor returns through balanced counseling and aggressive advocacy, showcasing its expertise in securities class actions and corporate governance litigation to support affected investors.
See More
