| | | 12月22日，据NMPA官网显示，海南合瑞制药提交的4类仿制药布地奈德肠溶胶囊获批上市，斩获国内首仿，打破云顶新耀在igAN对因治疗市场的独占局 面，重塑该领域竞争格局。 截图来源：NMPA 布地奈德肠溶胶囊是一款布地奈德的创新口服靶向迟释制剂，用于治疗具有进展风险的原发性IgA肾病成人患者。作为全球首个IgA肾病的对因治疗药物， 布地奈德肠溶胶囊不仅填补了国内从疾病源头治疗IgA肾病的空白，更为患者提供了创新的治疗选择。 大涨1581%重磅品种，云顶新耀独占鳌头 布地奈德肠溶胶囊原研公司为Calliditas，作为重磅药物，2019年，云顶新耀从Calliditas公司引进了该产品在大中华地区和新加坡的商业化权益，2023年11 月21日在国内获批上市，商品名为耐赋康，用于治疗具有进展风险的原发性免疫球蛋白A（IgA）肾病成人患者，以降低蛋白尿水平。2025年1月1日起布地 奈德肠溶胶囊正式纳入医保报销。 | 药品名称 | 通用名 | 医保目录剂型 ( | 注册剂型 0 | 医保类别 | 医保编号 | 药品分类(功能) | 区域 | 增补情况 | | --- | --- | --- | --- ...

The S&P 500 hit a record high on Wednesday, with broad gains across sectors supporting the main indexes during a shortened Christmas Eve session. The benchmark S&P 500 touched an intraday record high of 6,921.42 points, surpassing its previous peak in October, as investors continued to bet on more interest rate cuts from the Federal Reserve next year following mixed economic data. The U.S. economy grew at its fastest pace in two years in the third quarter, government data showed on Tuesday, after the releas ...

Stocks stocks closed higher on Wednesday, as the Dow Industrials and S&P 500 registered record closing highs in a broad rally during a holiday-shortened session.The blue-chip Dow rose 288.75 points, or 0.60%, to 48,731.16. The S&P 500 gained 0.3% to end at 6,932.05 points, while the Nasdaq climbed 0.2%.Indexes have been climbing in recent days, buoyed in part by a rebound in AI-related names after last week’s selloff that was triggered by concerns about inflated valuations and high capital expenditures dent ...

Whales with a lot of money to spend have taken a noticeably bullish stance on Johnson & Johnson.Looking at options history for Johnson & Johnson (NYSE:JNJ) we detected 11 trades.If we consider the specifics of each trade, it is accurate to state that 72% of the investors opened trades with bullish expectations and 0% with bearish.From the overall spotted trades, 4 are puts, for a total amount of $411,540 and 7, calls, for a total amount of $424,038.What's The Price Target?Analyzing the Volume and Open Inter ...

Company Overview - Agios Pharma has seen a stock return of -29% over the past year, underperforming the market by 47%, which supports a cautious investment stance [1] Leadership and Background - The company has a co-founder, Brendan, who has a Ph.D. in organic synthesis from Stanford University and has experience working with major pharmaceutical companies and biotech startups [1]

Core Viewpoint - Halper Sadeh LLC is investigating potential breaches of fiduciary duties by certain officers and directors of Eagle Pharmaceuticals, Inc. which may affect shareholder rights [1] Group 1: Shareholder Rights and Legal Options - Long-term shareholders of Eagle stock may seek corporate governance reforms, return of funds, court-approved financial incentives, or other benefits [2] - Shareholder involvement is crucial for improving company policies and practices, leading to enhanced shareholder value [3] Group 2: Legal Representation and Firm Background - Halper Sadeh LLC represents global investors affected by securities fraud and corporate misconduct, having recovered millions for defrauded investors [4]

Core Insights - Sanofi's new drug application (NDA) for tolebrutinib, a Bruton's tyrosine kinase (BTK) inhibitor for treating non-relapsing secondary progressive multiple sclerosis (nrSPMS), received a complete response letter (CRL) from the FDA [1] Regulatory Developments - The FDA's CRL for tolebrutinib was anticipated, as the review timeline had already been extended twice earlier this year [2] - The initial decision date of September 28, 2025, was pushed to December 28, 2025, due to Sanofi's submission of additional analyses deemed a major amendment [3] - Following the submission of an expanded access protocol at the FDA's request, the review date was revised again, with further guidance expected by the end of Q1 2026 [4] Market Performance - Over the past six months, Sanofi's shares have increased by 1.1%, while the industry has seen a rise of 20.4% [5] International Approvals - Tolebrutinib received provisional approval in the UAE for treating nrSPMS and slowing disability accumulation in adults [6] - A regulatory filing for a similar indication is currently under review in the European Union [6] Clinical Study Outcomes - The phase III PERCEUS study for tolebrutinib in primary progressive multiple sclerosis (PPMS) did not meet its primary endpoint [10] - Sanofi has decided not to pursue further development of tolebrutinib in PPMS, which represents 10% of the overall MS patient population [11] - In 2022, the FDA placed a partial clinical hold on phase III studies for tolebrutinib due to identified cases of drug-induced liver injury [11] Other Regulatory Approvals - The European Commission approved Wayrilz (rilzabrutinib) for immune thrombocytopenia (ITP) in adult patients refractory to other treatments [13] - The approval was based on data from the phase III LUNA 3 study, which met both primary and secondary endpoints [14]

Key Points The new indication is relatively rare in the U.S., but pricing is substantial, and the need for the treatment is significant. The positive update turns the company's fortunes around after a disappointing update earlier in the year. 10 stocks we like better than Agios Pharmaceuticals › Shares in Agios Pharmaceuticals (NASDAQ: AGIO) soared by more than 18% as of 11 a.m. today. The move follows the company's receipt of approval from the Food and Drug Administration (FDA) for AQVESME (mitapiv ...

Core Insights - Pfizer anticipates a significant revenue decline due to the loss of exclusivity for key products between 2026 and 2030, including Eliquis, Vyndaqel, Ibrance, Xeljanz, and Xtandi, all facing patent expirations [1][9] - The company has bolstered its R&D pipeline through mergers and acquisitions, successful data readouts, and pivotal program initiations, positioning itself for sustainable growth post-LOE [1][7] Oncology Pipeline - Pfizer has advanced its oncology pipeline with several candidates in late-stage development, including vepdegestrant for ER+/HER2- metastatic breast cancer, atirmociclib for HR+/HER2- metastatic breast cancer, and sigvotatug vedotin for metastatic non-small cell lung cancer [2] - By 2030, Pfizer expects to have eight or more blockbuster oncology medicines in its portfolio [4] Non-Oncology Developments - In non-oncology areas, Pfizer is developing an mRNA flu/COVID combination vaccine and osivelotor for sickle cell disease, both in late-stage development [4] - The company is also expanding the labels of approved products like Padcev, which was recently approved by the FDA in combination with Merck's Keytruda for specific bladder cancer patients [5] Obesity Market Expansion - Pfizer is strengthening its presence in the obesity market, currently dominated by Eli Lilly and Novo Nordisk, through the $10 billion acquisition of Metsera and the in-licensing of YP05002, an oral GLP-1 receptor agonist [6] - The Metsera acquisition added four novel clinical-stage programs for obesity, expected to generate billions in peak sales [6] Competitive Landscape - Pfizer faces revenue headwinds from patent expirations but is positioned for long-term growth through its expanding late-stage pipeline in oncology and investments in obesity, vaccines, and rare diseases [7] - The oncology market is competitive, with major players like AstraZeneca, Merck, Johnson & Johnson, and Bristol-Myers also focusing on oncology sales [10][11][12][13] Financial Performance - Pfizer's stock has declined 7% over the past year, while the industry has seen a 16% increase [14] - The company's shares are trading at a forward price/earnings ratio of 8.18, below the industry average of 17.40 and its own 5-year mean of 10.39, indicating attractive valuation [16] - The Zacks Consensus Estimate for 2025 earnings has increased slightly to $3.10 per share, while the estimate for 2026 has decreased to $3.04 per share [18]

Core Insights - Agios Pharmaceuticals (AGIO) received FDA approval for Aqvesme (mitapivat) to treat adult patients with alpha- or beta-thalassemia, making it the only FDA-approved drug for both non-transfusion-dependent and transfusion-dependent forms of the disease [1][6] - The launch of Aqvesme is anticipated in late January 2026, following the implementation of the AQVESME REMS program [2][6] - The approval is based on phase III ENERGIZE and ENERGIZE-T studies, which showed significant improvements in hemoglobin levels, fatigue, and reduced blood transfusion needs compared to placebo [3][6] Regulatory and Market Context - The FDA's approval included a Risk Evaluation and Mitigation Strategy (REMS) due to reported cases of hepatocellular injury among treated patients, which may have negatively impacted investor sentiment, leading to a 1.5% decline in AGIO's stock [4][6] - AGIO's shares have decreased by 28.1% over the past year, while the industry has seen a rise of 16.8% [5] Future Developments - Agios has filed for regulatory approval of Aqvesme in the European Union, with a positive opinion from the EMA expected to lead to a final decision in early 2026 [9] - Outside the U.S., mitapivat will continue to be marketed as Pyrukynd for both PK deficiency and thalassemia indications, with ongoing studies for sickle cell disease [10]