FDA Refuses Approval for Corcept's Relacorilant Drug
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Jan 30 2026
0mins
Should l Buy CORT?
Source: stocktwits
- FDA Rejection: The U.S. FDA refused to approve Corcept's Relacorilant in December, citing insufficient clinical trial results to demonstrate effectiveness in treating hypercortisolism, leading to an 11% drop in the company's stock on Friday, reflecting strong market reaction to the decision.
- CEO's Response: Corcept CEO Joseph K. Belanoff expressed surprise and disappointment at the FDA's decision and committed to meeting with the agency to discuss a path forward, indicating the company's ongoing dedication to drug development despite setbacks.
- Clinical Data Requirements: The FDA's refusal letter highlighted the need for new clinical data to address concerns regarding Relacorilant's efficacy and risks of drug-induced liver injury, which may necessitate a full re-do of late-stage trials, potentially delaying the drug's market entry.
- Market Sentiment Shift: On Stocktwits, retail sentiment around CORT stock remained in the 'bearish' territory, although chatter improved from 'extremely low' to 'low' levels over the past 24 hours, indicating mixed investor reactions to the FDA rejection and future prospects.
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Analyst Views on CORT
Wall Street analysts forecast CORT stock price to rise
6 Analyst Rating
4 Buy
1 Hold
1 Sell
Moderate Buy
Current: 38.340
Low
50.00
Averages
91.00
High
121.00
Current: 38.340
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.
Pomerantz LLP Investigates Securities Fraud Claims Against Corcept Therapeutics
- Investigation Launched: Pomerantz LLP is investigating claims of securities fraud against Corcept Therapeutics, focusing on whether the company and its executives engaged in unlawful business practices, which could undermine investor confidence and lead to stock price volatility.
- 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 pivotal GRACE trial met its primary endpoint, additional evidence of effectiveness is required, indicating regulatory hurdles that may affect future drug approval.
- Stock Price Plunge: Following the FDA announcement, Corcept's stock price fell by $35.40, a 50.42% drop, closing at $34.80 per share, reflecting market pessimism regarding the company's prospects and potentially leading to significant investor losses.
- Legal Context: Pomerantz LLP, a prominent firm in securities class action litigation with over 85 years of experience, focuses on advocating for victims of securities fraud; if the investigation confirms fraudulent activities, it could trigger large-scale class action lawsuits, further impacting the company's reputation.
See More
Corcept's Treatment Faces FDA Warning, Shares Plummet
- FDA Warning Impact: On January 30, 2026, the FDA warned Corcept on several occasions against submitting its relacorilant drug application, 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 stemming from regulatory scrutiny.
- Poor Clinical Trial Results: Despite Corcept's claims of relacorilant's significant efficacy 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 shareholder rights law firms to investigate whether the company misled investors, potentially leading to further legal risks.
- Diminished Business 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 the issuance of the CRL have cast significant doubt on this target, potentially impacting the company's long-term strategic planning.
See More
DJS Law Group Investigates Corcept for Securities Violations
- Investigation Background: DJS Law Group is investigating Corcept Therapeutics for potential violations of securities laws, particularly focusing on whether misleading statements were made or critical information was withheld from investors, indicating a significant threat to investor rights.
- FDA Response: On December 31, 2026, Corcept revealed that the FDA issued a Complete Response Letter regarding the New Drug Application for relacorilant, stating that while the pivotal GRACE trial met its primary endpoint, the FDA concluded that additional evidence of effectiveness was necessary, posing major challenges for the company.
- Stock Price Impact: Following the FDA's announcement, Corcept's shares plummeted by over 50%, reflecting not only the market's pessimistic outlook on the company's future prospects but also potentially leading to a severe erosion of investor confidence.
- Legal Consequences: DJS Law Group specializes in securities class actions and corporate governance litigation, indicating that if the investigation confirms violations, it could have profound implications for Corcept's legal liabilities and financial impact.
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 Securities Fraud Claims Against Corcept Therapeutics
- Investigation Launched: Pomerantz LLP is investigating claims of securities fraud against Corcept Therapeutics, focusing on whether the company and its executives engaged in unlawful business practices, which could undermine investor confidence and lead to stock price volatility.
- 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 pivotal GRACE trial met its primary endpoint, additional evidence of effectiveness is required, indicating regulatory hurdles that may affect future drug approval.
- Stock Price Plunge: Following the FDA announcement, Corcept's stock price fell by $35.40, a 50.42% drop, closing at $34.80 per share, reflecting market pessimism regarding the company's prospects and potentially leading to significant investor losses.
- Legal Context: Pomerantz LLP, a prominent firm in securities class action litigation with over 85 years of experience, focuses on advocating for victims of securities fraud; if the investigation confirms fraudulent activities, it could trigger large-scale class action lawsuits, further impacting the company's reputation.
See More
Corcept's Treatment Faces FDA Warning, Shares Plummet
- FDA Warning Impact: On January 30, 2026, the FDA warned Corcept on several occasions against submitting its relacorilant drug application, 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 stemming from regulatory scrutiny.
- Poor Clinical Trial Results: Despite Corcept's claims of relacorilant's significant efficacy 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 shareholder rights law firms to investigate whether the company misled investors, potentially leading to further legal risks.
- Diminished Business 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 the issuance of the CRL have cast significant doubt on this target, potentially impacting the company's long-term strategic planning.
See More
DJS Law Group Investigates Corcept for Securities Violations
- Investigation Background: DJS Law Group is investigating Corcept Therapeutics for potential violations of securities laws, particularly focusing on whether misleading statements were made or critical information was withheld from investors, indicating a significant threat to investor rights.
- FDA Response: On December 31, 2026, Corcept revealed that the FDA issued a Complete Response Letter regarding the New Drug Application for relacorilant, stating that while the pivotal GRACE trial met its primary endpoint, the FDA concluded that additional evidence of effectiveness was necessary, posing major challenges for the company.
- Stock Price Impact: Following the FDA's announcement, Corcept's shares plummeted by over 50%, reflecting not only the market's pessimistic outlook on the company's future prospects but also potentially leading to a severe erosion of investor confidence.
- Legal Consequences: DJS Law Group specializes in securities class actions and corporate governance litigation, indicating that if the investigation confirms violations, it could have profound implications for Corcept's legal liabilities and financial impact.
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
