FDA Approvals & Rejections - ARS Pharma's neffy, a needle-free epinephrine nasal spray for emergency treatment of Type I allergic reactions, received approval in China, with commercial availability expected in spring 2026. The product generated $31.3 million in U.S. revenue in Q3 2025 [3][4]. - Vanda Pharmaceuticals' NEREUS, an oral NK-1 receptor antagonist for preventing motion-induced vomiting, received FDA approval, marking the first new treatment for motion sickness in over 40 years. The drug demonstrated a meaningful reduction in vomiting in clinical trials [5][6]. Clinical Trials - Breakthroughs & Setbacks - InflaRx's analyses from a halted Phase 3 trial of Vilobelimab in pyoderma gangrenosum indicated potential efficacy signals with longer treatment duration, prompting plans to discuss alternative endpoints with the FDA [15][17]. - SELLAS reported that survival in its Phase 3 REGAL trial for Galinpepimut-S (GPS) in acute myeloid leukaemia is extending longer than anticipated, potentially increasing the likelihood of a positive outcome [18][19]. - Ultragenyx announced that its Phase 3 studies for Setrusumab in Osteogenesis Imperfecta failed to meet primary endpoints, leading to a decline in investor confidence [20][21]. - Genmab decided to discontinue clinical development of Acasunlimab to focus on higher-priority programs, with no impact expected on its full-year 2025 financial guidance [22][23]. Corporate Actions - FONAR Corporation agreed to be taken private by a CEO-led acquisition group for $19.00 per share, valuing the transaction at a significant premium. The deal is expected to close in Q3 2026, subject to shareholder approval [12][13][14].

Core Viewpoint - U.S. financial markets are experiencing a pause for the New Year's Day holiday, with trading set to resume on January 2nd, 2026. Despite a recent pullback, 2025 was a strong year for major stock indexes, which posted significant gains. Market Performance - On December 31st, 2025, major U.S. stock indexes closed lower, continuing a four-session losing streak. The Dow Jones Industrial Average fell 0.6% to 48,063.29, the S&P 500 declined 0.7% to 6,845.50, and the Nasdaq Composite dropped 0.8% to 23,241.99. Trading volume was light as many institutional investors had closed their books for the year [2][3]. - Sector performance was predominantly negative, with technology stocks being a major drag. The Energy Select Sector SPDR rose 0.8%, while the Information Technology Select Sector SPDR, Financials Select Sector SPDR, and Industrials Select Sector SPDR all declined by 0.3% [4]. Notable Stock Movements - Ares Management Corporation saw a share decline of 3.4%. Micron Technology and Western Digital experienced drops of 2.5% and 2.2%, respectively. Corcept Therapeutics shares plunged significantly after the FDA did not approve its treatment. Conversely, Nike shares rose 4.1% following the CEO's purchase of approximately $1 million in company stock [5]. Year-End Market Drivers - The strong performance in 2025 was largely driven by optimism surrounding artificial intelligence, with companies like Micron Technology, Palantir, Advanced Micro Devices, Alphabet, and Nvidia being significant contributors. The S&P 500 finished 2025 up approximately 16.4%, the Nasdaq Composite surged around 20.4%, and the Dow Jones Industrial Average added roughly 13% [6]. Upcoming Economic Data - Key economic data releases are scheduled for early January, including Initial Claims data and Construction PDF on January 2nd, ISM Manufacturing index on January 5th, and various employment reports on January 7th. Important inflation indicators like the Consumer Price Index and Producer Price Index will be released on January 13th and 14th, respectively [8]. Federal Reserve Meeting - The U.S. Federal Reserve's Federal Open Market Committee meeting is set for January 28th, where market participants will seek guidance on monetary policy for 2026, particularly regarding inflation and potential interest rate adjustments [9]. Upcoming Earnings Releases - The earnings season for Q4 2025 will begin to gain momentum later in January, with notable companies like BHP Group, JPMorgan Chase, and Bank of America expected to report. These earnings will provide critical insights into corporate performance and outlooks for the new year [10].

Group 1: Corcept Medical - Corcept Medical's stock plummeted by 50% after the FDA rejected its drug application for treating a rare hormonal disorder, resulting in a market value loss of $3.7 billion [1][3]. - The FDA's complete response letter indicated that while the company's GRACE clinical trial met its primary endpoint, additional evidence of efficacy is required for a favorable benefit-risk assessment [3][4]. - Corcept's CEO expressed disappointment but remains committed to finding a way to bring the drug Relacorilant to patients, planning to meet with the FDA to discuss next steps [3][4]. Group 2: Relacorilant Drug Details - Relacorilant is a selective cortisol modulator aimed at treating conditions like endogenous hypercortisolism and ovarian cancer, and it has orphan drug designation from both the FDA and the European Commission [5][6]. - The drug has shown improvements in various symptoms associated with hypercortisolism, which can lead to serious health issues such as diabetes and hypertension [4][5]. - The FDA has set a target date of July 11, 2026, for the drug's use in treating platinum-resistant ovarian cancer patients [6]. Group 3: Indian Tobacco Market - Indian tobacco stocks experienced significant declines, with ITC's stock dropping over 9% and Godfrey Phillips India falling more than 16% following the announcement of a substantial increase in cigarette consumption tax [1][7]. - The new tax, effective February 1, will impose a consumption tax based on cigarette length, potentially increasing overall costs by 22%-28% for certain products [7][8]. - Analysts predict that the increased tax burden may lead to higher retail prices and could negatively impact cigarette sales, with concerns about a shift to illegal tobacco markets [7][8].

周三，Corcep医疗(CORT.US)股价暴跌超50.42%，收于34.80美元。 Corcept Therapeutics 表示已收到美国食品药品监督管理局(FDA)发出的完整回应函，其新药申请未获批准。该申请旨在寻求批准口服药物 Relacorilant用于治疗因皮质醇增多症(高皮质醇血症)引发的继发性高血压。 Corcept Therapeutics围绕库欣综合征开展了多项临床试验。 公司称，FDA在回应函中确认，Corcept的关键性GRACE临床试验达成主要终点，且GRADIENT试验数据具有验证性意义；但监管机构认为， 现有资料仍不足以支持对该疗法作出有利的收益—风险评估，因而要求补充更多有效性证据。 Relacorilant为一种选择性的糖皮质激素受体拮抗剂，关键临床GRACE中达到降血压主要终点，63%的患者达到响应标准。 患者血糖控制获得改善。 患者生活质量、认知评估获得显著改善。 对此，Corcept首席执行官Joseph K. Belanoff表示，公司"对这一结果感到意外和失望"，并称将"尽快与FDA会面，讨论并确定最佳的后续推 进路径"。 资料显示，relacorilant为一种口 ...

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]