LOS ANGELES--(BUSINESS WIRE)---- $CORT--CORT Investors Have Opportunity to Join Corcept Therapeutics Incorporated Fraud Investigation with the Schall Law Firm. ...

Core Viewpoint - Corcept Therapeutics experienced a significant decline in share price, dropping 50% after receiving a complete response letter from the FDA regarding its treatment relacorilant for hypercortisolism, leading to a loss of over $3.6 billion in market capitalization [1][3]. Company Overview - Corcept Therapeutics has previously promoted relacorilant's efficacy and commercial potential, claiming that clinical trial patients showed meaningful improvements in hypercortisolism symptoms [3]. - The company expressed confidence in achieving annual revenues of $3 billion to $5 billion from its hypercortisolism business within three to five years [3]. FDA Response - The FDA's complete response letter indicated that additional evidence of relacorilant's effectiveness was required for a favorable benefit-risk assessment [3]. - A reported finding indicated that loss of blood pressure control was 83% less likely in the relacorilant group compared to placebo [3]. Market Reaction - Following the FDA's announcement, Corcept's share price fell over $35, resulting in a 50% decrease in value on December 31, 2025 [1][3].

Core Insights - Scott+Scott Attorneys at Law LLP is investigating Corcept Therapeutics Incorporated for potentially issuing misleading statements and failing to disclose material information to investors, which may violate federal securities laws [1][3]. Company Overview - Corcept Therapeutics is a pharmaceutical company focused on the discovery, development, and commercialization of drugs for severe metabolic, psychiatric, and oncologic disorders [2]. Recent Developments - On December 31, 2025, Corcept announced that the U.S. Food and Drug Administration issued a Complete Response Letter regarding the New Drug Application for relacorilant, indicating that additional evidence of effectiveness is required for a favorable benefit-risk assessment [3]. - Following the FDA's announcement, Corcept's stock price dropped over 50%, closing at $34.80 per share on the same day [3].

Corcept has also repeatedly assured investors that "[o]ur new drug application for relacorilant is progressing toward approval by the end of" 2025 and "[r]elacorilant's strong efficacy and safety profile gives us the potential to become the new standard of care for patients with hypercortisolism." Critically, Corcept's management also expressed confidence that "we're [more] confident than ever that we're on track to grow our hypercortisolism business from $3 billion to $5 billion in annual revenues in three ...

Company Overview - Corcept Therapeutics (CORT) shares increased by 9.8% to close at $38.2, following a significant volume of trading, despite a previous 58.9% loss over the past four weeks [1] - The stock experienced a decline after the FDA issued a complete response letter regarding its new drug application for relacorilant, aimed at treating hypercortisolism (Cushing's syndrome) [1] Earnings Expectations - Analysts project Corcept to report quarterly earnings of $0.27 per share, reflecting a year-over-year increase of 3.9% [2] - Revenue expectations stand at $254.39 million, which indicates a 39.9% increase compared to the same quarter last year [2] Stock Performance Insights - The consensus EPS estimate for Corcept has remained unchanged over the last 30 days, suggesting that stock price movements may not sustain without trends in earnings estimate revisions [4] - The stock currently holds a Zacks Rank of 3 (Hold), indicating a neutral outlook [5] Industry Comparison - Corcept is part of the Zacks Medical - Drugs industry, where another company, Collegium Pharmaceutical (COLL), saw a 1.7% decrease in its stock price, closing at $45.53, with a -2.4% return over the past month [5] - Collegium's consensus EPS estimate for its upcoming report is $2.21, representing a 24.9% increase from the previous year, and it holds a Zacks Rank of 1 (Strong Buy) [6]

Company Overview - Corcept Therapeutics is a commercial-stage biotech company focused on treatments for cortisol modulation, particularly related to Cushing's Syndrome [1] Product Information - Since 2012, the company has marketed Korlym as a treatment for Cushing's Syndrome [1]

Market Overview - U.S. stocks opened 2026 with modest gains, with the Dow Jones Industrial Average and S&P 500 rising, while the Nasdaq Composite lagged behind, reflecting cautious optimism after a strong 2025 for equities [1] - Trading volumes were light, indicating a rebound from late-December weakness [1] Sector Performance - Chipmakers, particularly Nvidia and Micron, led early gains due to ongoing enthusiasm around AI demand, although weakness in several megacap technology and consumer discretionary stocks limited broader market gains [2] Economic Outlook - Investors are focusing on upcoming economic data and Federal Reserve signals to assess the outlook for rates and growth in 2026, with strategists cautioning that early January market movements may not dictate future trends [3] Bullish Stocks - Nike, Inc. shares rose nearly 3% following insider buying, which is seen as a vote of confidence in the company's turnaround strategy, with CEO Elliott Hill purchasing approximately $1 million in shares [4] - Energy Fuels Inc. exceeded its production guidance, mining over 1.6 million pounds of uranium and projecting Q4 sales around 360,000 pounds, generating approximately $27 million in revenue [6] - A potential SpaceX IPO in 2026 could significantly impact the market, potentially leading to capital rotation from Tesla as investors buy SpaceX shares, while ultimately benefiting Elon Musk-linked companies [5] Bearish Stocks - U.S.-listed Chinese tech stocks, including Alibaba, JD.com, and PDD Holdings, declined due to thin holiday trading volumes and disappointing economic data from China, reflecting broader market weakness [7] - Ultragenyx Pharmaceutical and Mereo BioPharma shares fell to 52-week lows after a late-stage clinical trial for a bone disease therapy failed to meet its primary endpoint [8] - Corcept Therapeutics shares dropped sharply following an FDA refuse-to-file letter for its investigational drug relacorilant, which surprised investors and led to reassessment of the company's regulatory pathway [9]

Company Overview - Intelligent Bio Solutions Inc. (NASDAQ:INBS) announced plans to raise $10 million through a private placement, leading to a significant drop in its share price [1] - Following the announcement, shares of Intelligent Bio fell 19.7% to $7.65 [1] Stock Movements - Lavoro Limited (NASDAQ:LVRO) saw a substantial increase of 181%, reaching $1.2900 [4] - Ironwood Pharmaceuticals, Inc. (NASDAQ:IRWD) rose 57.7% to $5.32 after issuing FY26 guidance, expecting US net sales of Linzess to be between $1.125 billion and $1.175 billion [4] - Brand Engagement Network, Inc. (NASDAQ:BNAI) jumped 56% to $3.6290 after entering a Vendor Services Project Agreement with a global advertising agency [4] - ChowChow Cloud International Holdings Limited (NYSE:CHOW) increased by 39.7% to $0.8500 due to year-over-year revenue and net income growth in H1 2025 [4] - Sidus Space, Inc. (NASDAQ:SIDU) gained 29% to $4.0314, marking a 470% surge over the past month [4] - Baidu, Inc. (NASDAQ:BIDU) rose 12.1% to $146.57 after announcing a proposed spin-off and Hong Kong listing of its AI unit [4] Declines - Outlook Therapeutics, Inc. (NASDAQ:OTLK) experienced a significant decline of 58% to $0.6632 after receiving a complete response letter from the FDA regarding its biologics license application [4] - ESH Acquisition Corp. (NASDAQ:ESHA) fell 23.5% to $14.68 [4] - Nuvve Holding Corp. (NASDAQ:NVVE) declined 15.3% to $2.1500 after announcing the closing of a private placement [4]

Core Insights - Corcept Therapeutics (CORT) received a complete response letter (CRL) from the FDA regarding its new drug application (NDA) for relacorilant, a selective cortisol modulator intended for treating hypercortisolism (Cushing's syndrome) [1][5] - Following the announcement, Corcept's shares fell by 50.4% on December 31, 2025 [1][5] - The FDA's decision was based on the need for additional evidence of relacorilant's effectiveness, despite positive results from the GRACE and GRADIENT studies [3][5] Regulatory Developments - The NDA for relacorilant was submitted in December 2024, with an expected decision date of December 30, 2025 [2] - The FDA indicated that further studies are required to establish the drug's effectiveness for patients with hypertension secondary to hypercortisolism, which may delay approval [4] Financial Impact - Over the past six months, Corcept's shares have decreased by 51.8%, contrasting with a 3.4% increase in the industry [4] - Korlym, Corcept's currently marketed drug for Cushing's syndrome, generated sales of $559.3 million in the first nine months of 2025, reflecting a year-over-year increase of approximately 13.4% [9] Future Prospects - Corcept is also pursuing relacorilant for other indications, including a combination therapy for platinum-resistant ovarian cancer, with regulatory decisions expected in 2026 [6][7] - The outcome of the FDA's CRL for relacorilant in Cushing's syndrome may influence the upcoming decision regarding its use in ovarian cancer [9]

Core Viewpoint - Corcept Therapeutics faced a significant setback after the FDA rejected its application for relacorilant, a treatment for Cushing's syndrome, due to insufficient data for a favorable benefit-risk assessment [1][3][4] Company Impact - The FDA's rejection has led to a 70% decline in CORT stock compared to its March high, indicating a drastic market reaction [2] - Relacorilant was expected to be a key product for Corcept's growth strategy, aimed at diversifying beyond its existing Korlym franchise [3][4] - The company now faces uncertainty as it must conduct additional trials, which will be costly and time-consuming [4] Market Competition - The rejection hampers Corcept's ability to compete with Xeris Biopharma's Recorlev in the Cushing's syndrome market, which is projected to triple from the current $1 billion by the end of the decade [5] - The extended timeline for relacorilant's development may allow Recorlev to capture a larger market share [5] Technical Analysis - CORT shares are trading below major moving averages, indicating ongoing weakness in the stock [6] - Insider selling has been prevalent over the past 12 months, reinforcing bearish sentiment for Corcept heading into 2026 [6] Wall Street Sentiment - Prior to the FDA decision, Wall Street had a consensus "Moderate Buy" rating on Corcept stock, with a mean target of approximately $127, suggesting an upside potential of about 80% from its previous close [7]