Core Viewpoint - Corcept Therapeutics has received a complete response letter from the FDA indicating that its new drug application for Relacorilant has not been approved for treating secondary hypertension caused by hypercortisolism [2][4]. Group 1: FDA Response and Clinical Trials - The FDA confirmed that Corcept's pivotal GRACE clinical trial met its primary endpoint, and the data from the GRADIENT trial is considered confirmatory [4]. - However, the FDA requires additional evidence of efficacy to support a favorable benefit-risk assessment for the therapy [4]. - Corcept has conducted multiple clinical trials related to Cushing's syndrome [12]. Group 2: Patient Outcomes - Improvements in blood sugar control have been observed in patients [6]. - Significant enhancements in patients' quality of life and cognitive assessments have been reported [9]. Group 3: Future Development Plans - Corcept's CEO expressed surprise and disappointment at the FDA's decision and stated that the company will meet with the FDA to discuss the best path forward [16]. - Relacorilant is a selective glucocorticoid receptor antagonist being developed not only for endogenous hypercortisolism but also for ovarian cancer and other diseases [16]. - The PDUFA date for the application concerning platinum-resistant ovarian cancer is set for July 11, 2026, with market approval expected by the end of 2026 [17][18].

Core Insights - Corcept Therapeutics faced a significant setback as the FDA issued a complete response letter, declining to approve its relacorilant medication, leading to a share price drop of over 50% [1][2][4] - The FDA acknowledged that relacorilant met its primary endpoint in clinical trials but required additional evidence of effectiveness for a favorable benefit-risk assessment [3][4] - Corcept plans to continue pursuing commercialization of relacorilant and intends to meet with FDA officials to discuss potential next steps [3][4] Company Performance - The company's share price experienced a drastic decline of just over 50% following the FDA's decision [1] - The FDA's rejection is viewed as a significant defeat for Corcept, indicating challenges ahead for the drug's approval process [4][7] Future Prospects - Corcept is determined to find a way to commercialize relacorilant, although this may involve additional clinical trials, complicating the approval process [3][4] - The FDA's response suggests that any future success will require substantial evidence to support the drug's effectiveness [4][7]

Core Insights - Corcept Therapeutics experienced a significant stock decline of approximately 50% on December 31 due to the FDA's request for additional data on relacorilant, its treatment for Cushing's syndrome, raising concerns about the company's pipeline strength [1][2] - The setback has led analysts to remove relacorilant from financial models, negatively impacting investor confidence and future revenue expectations [2][3] - Despite the negative news, some analysts believe the market reaction may be exaggerated, suggesting potential upside for the stock if management can address regulatory concerns [4][6] Financial Performance - In the latest reported quarter, Corcept generated nearly $20 million in net income and $208 million in revenue, reflecting a year-over-year increase of approximately 14% [7] - The company's price-to-sales (P/S) ratio is around 10, which is considered reasonable for a fast-growing biotech firm [5] Market Position and Future Outlook - Korlym, Corcept's existing product, is facing pressure from generic competition, particularly from Teva Pharmaceuticals, limiting growth potential in its primary therapeutic area [3] - The ongoing research in ovarian cancer and the potential of relacorilant in oncology could provide new revenue streams, indicating that the company is not fundamentally broken despite recent setbacks [8][9] - The current valuation may present an attractive entry point for long-term investors, especially if the company can successfully navigate regulatory challenges and diversify its pipeline [8]

Market Overview - U.S. stocks experienced a decline, with the Dow Jones index falling over 100 points, down 0.28% to 48,229.87, NASDAQ slipping 0.26% to 23,359.33, and S&P 500 dropping 0.26% to 6,878.07 [1] - European shares also fell, with the eurozone's STOXX 600 down 0.14%, Spain's IBEX 35 Index down 0.27%, London's FTSE 100 down 0.09%, and France's CAC 40 down 0.23% [6] - Asian markets closed mixed, with Hong Kong's Hang Seng Index down 0.87%, China's Shanghai Composite up 0.09%, and India's BSE Sensex up 0.64% [7] Commodities - In commodity trading, oil increased by 0.1% to $58.02, while gold decreased by 0.8% to $4,351.00. Silver fell 7.3% to $72.255, and copper dropped 1.9% to $5.6710 [5] Company News - Anghami Inc. shares surged 50% to $3.7306 following a year-over-year increase in H1 results [9] - Vanda Pharmaceuticals Inc. saw a 32% increase in shares to $9.28 after receiving FDA approval for NEREUS [9] - Intelligent Bio Solutions Inc. shares rose 102% to $8.27 due to a strategic manufacturing partnership with Syrma Johari MedTech [9] - Corcept Therapeutics Incorporated shares plummeted 52% to $34.04 after receiving a Complete Response Letter from the FDA [9] - FuelCell Energy, Inc. shares fell 10% to $7.18 after filing for an amended common stock offering [9] - SMX Public Limited Company shares dropped 37% to $32.30 [9] Economic Indicators - U.S. initial jobless claims decreased by 16,000 to 199,000, better than market estimates of 220,000 [10] - U.S. crude oil inventories, excluding the Strategic Petroleum Reserve, fell by 1.934 million barrels, marking the largest weekly decline since mid-November, compared to market estimates of a 0.9 million-barrel decrease [10][2]

Core Viewpoint - The FDA has determined that there is insufficient evidence of effectiveness for relacorilant in treating patients with Cushing syndrome and hypertension, resulting in a significant decline in the stock price [1] Group 1 - The FDA's decision highlights concerns regarding the efficacy of relacorilant, which may impact its market potential and investor confidence [1] - The announcement has led to a sharp decrease in the stock value, indicating a negative market reaction to the FDA's findings [1]

Core Viewpoint - Corcept Therapeutics (CORT.US) experienced a significant stock decline of over 46% following the announcement that its new drug application for Relacorilant was not approved by the FDA [1][2] Group 1: FDA Response - The FDA issued a complete response letter indicating that while the key GRACE clinical trial met its primary endpoint and the GRADIENT trial data is considered confirmatory, the existing data is insufficient for a favorable benefit-risk assessment [1] - The FDA has requested additional evidence of efficacy to support the drug's approval [1] Group 2: Company Reaction - Corcept's CEO, Joseph K. Belanoff, expressed surprise and disappointment regarding the FDA's decision and stated that the company will meet with the FDA as soon as possible to discuss the best path forward [1] Group 3: Drug Information - Relacorilant is an oral selective glucocorticoid receptor antagonist, which is being developed not only for endogenous Cushing's syndrome but also for ovarian cancer and other conditions [2] - The setback in approval introduces further uncertainty into the commercialization process of the drug, with market attention now focused on subsequent regulatory communications and the development of supplementary research plans [2]

Core Viewpoint - Corcept Medical's stock price plummeted over 46% to $37.33 following the announcement that its new drug application for Relacorilant was not approved by the FDA [1] Group 1: FDA Response - The FDA issued a complete response letter indicating that while Corcept's key GRACE clinical trial met its primary endpoint and the GRADIENT trial data is considered confirmatory, the existing data is insufficient for a favorable benefit-risk assessment [1] - The FDA has requested additional evidence of efficacy to support the drug's approval [1] Group 2: Company Reaction - Corcept's CEO Joseph K. Belanoff expressed surprise and disappointment at the FDA's decision and stated that the company will meet with the FDA as soon as possible to discuss the best path forward [1] Group 3: Drug Information - Relacorilant is an oral selective glucocorticoid receptor antagonist, being developed not only for endogenous Cushing's syndrome but also for ovarian cancer and other conditions [1] - The setback in approval introduces further uncertainty into the commercialization process of the drug, with market attention now focused on subsequent regulatory communications and the advancement of supplementary research plans [1]

U.S. stocks traded mostly lower this morning, with the Dow Jones index falling more than 50 points on Wednesday.Following the market opening Wednesday, the Dow traded down 0.09% to 48,322.35 while the NASDAQ slipped 0.01% to 23,417.48. The S&P 500 also fell, dropping, 0.04% to 6,893.58.Check This Out: How To Earn $500 A Month From UniFirst Stock Ahead Of Q1 EarningsLeading and Lagging SectorsInformation technology shares rose by 0.2% on Wednesday.In trading on Wednesday, real estate stocks fell by 0.3%.Top ...

Group 1 - U.S. stock futures are mostly lower, with Dow futures down approximately 0.01% [1] - Cybin Inc launched a $100 million at-the-market equity program with Cantor Fitzgerald, resulting in a 6.6% drop in shares to $8.00 in pre-market trading [1] Group 2 - Jefferson Capital Inc shares decreased by 7.2% to $21.08 in pre-market trading [2] - SMX PLC shares fell 6.8% to $47.95 after a significant decline of 39% on Tuesday [2] - Corcept Therapeutics Inc shares declined by 5.5% to $66.35 following a 12% drop on Tuesday [2] - NovaBay Pharmaceuticals Inc shares fell 4.8% to $5.90 in pre-market trading [2] - Americas Gold and Silver Corporation shares decreased by 4.7% to $5.09 [2] - Xpeng Inc – ADR shares slipped 4.5% to $20.32 after a 4% increase on Tuesday [2] - B&G Foods Inc shares fell 3.6% to $4.35 in pre-market trading [2] - Hecla Mining Co shares decreased by 3.3% to $18.85 in pre-market trading [2]

The U.S. Food and Drug Administration has declined to approve Corcept Therapeutics' hormone-blocking drug for the treatment of a rare hormonal disorder, the company said on Wednesday. ...