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新一代BCL2抑制剂索托克拉获批上市 重塑B细胞淋巴瘤治疗格局
Huan Qiu Wang· 2026-01-07 07:25
来源:环球网 "索托克拉在中国加速获批并实现全球首发,无疑是百济神州血液学产品管线进展的重要里程碑,标志 着我们的又一款自研药物将正式开始帮助患者,也进一步印证了百济神州在B细胞恶性肿瘤治疗领域的 引领性。"百济神州总裁、全球研发负责人汪来博士表示,"索托克拉在中国从受理至获批仅用时8个 月,此得益于索托克拉在研究中展现出深度且持久的缓解获益与良好的安全性,展示出其具备成为同类 最佳BCL2抑制剂的潜力,另外也反映出中国血液肿瘤患者出现耐药后的迫切治疗需求已被重视。我们 还在进一步探索索托克拉的潜力,以期帮助到全球更多患者。" 1月6日,百济神州宣布,旗下新一代BCL2抑制剂索托克拉片(百悦达®)获得国家药品监督管理局 (NMPA)附条件批准上市,用于治疗既往接受过至少包含布鲁顿酪氨酸激酶(BTK)抑制剂在内的一 种系统治疗的慢性淋巴细胞白血病(CLL)/小淋巴细胞淋巴瘤(SLL)成人患者,以及既往接受过至少 两种系统性治疗(含布鲁顿酪氨酸激酶[BTK]抑制剂)的复发或难治性套细胞淋巴瘤(MCL)成人患 者。此前,这两项适应症的上市申请已被NMPA药品审评中心(CDE)纳入优先审评程序。 据悉,索托克拉此次以 ...
Ionis partner GSK announces positive topline results from B-Well 1 and B-Well 2 Phase 3 studies for bepirovirsen, a potential first-in-class medicine for chronic hepatitis B
Businesswire· 2026-01-07 07:15
Core Insights - GSK announced positive results from two pivotal Phase 3 studies, B-Well 1 and B-Well 2, for bepirovirsen, an investigational antisense oligonucleotide for chronic hepatitis B treatment [1] Company Summary - Ionis Pharmaceuticals partnered with GSK for the development of bepirovirsen, which has shown promising safety and efficacy results in over 1,800 patients across 29 countries [1]
GSK's chronic hepatitis B treatment meets main goal in key studies
Reuters· 2026-01-07 07:09
Core Insights - GSK's experimental drug for chronic hepatitis B infection has successfully met the main goals in two significant studies, indicating progress towards a potential functional cure for patients [1] Company Summary - GSK is advancing its research in chronic hepatitis B treatment with promising results from its experimental drug [1]
Biogen Inc. (NASDAQ:BIIB) Overview: Key Developments and Financial Performance
Financial Modeling Prep· 2026-01-07 07:08
Biogen's collaboration with Eisai Co., Ltd. on Alzheimer's treatment "LEQEMBI" marks a significant stride in neurological disease management.The acceptance of the Biologics License Application for LEQEMBI in China could open new market opportunities for Biogen.Biogen's stock has seen a 15.1% increase in 2025, driven by successful product launches and a 29.9% increase in sales for Skyclarys.Biogen Inc. (NASDAQ:BIIB) is a leading biotechnology company with a focus on developing treatments for neurological dis ...
Cyclerion Therapeutics, Inc. (CYCN) Discusses Medsteer Development Collaboration and Updates on Phase 2 Proof-of-Concept Study in Treatment-Resistant Depression - Slideshow (NASDAQ:CYCN) 2026-01-07
Seeking Alpha· 2026-01-07 06:30
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Pfizer (NYSE:PFE) Price Target and Stock Analysis
Financial Modeling Prep· 2026-01-07 05:08
UBS set a price target of $25 for Pfizer (NYSE:PFE), indicating a slight overvaluation based on the current stock price of $25.43.Pfizer's stock has experienced a decline of 2.3% over the past month, underperforming against the Zacks S&P 500 composite and the Zacks Large Cap Pharmaceuticals industry.The company's market capitalization stands at approximately $144.59 billion, with a trading volume of 38,061,592 shares, highlighting significant investor interest.On January 6, 2026, UBS set a price target of $ ...
Pfizer: 2026 Guidance Points To Continued Margin And Growth Pressure (NYSE:PFE)
Seeking Alpha· 2026-01-07 04:59
Group 1 - Envision Research, led by Lucas Ma, has over 20 years of investment experience and specializes in quantitative investment and renewable energy [1] - The firm offers two model portfolios: one focused on short-term survival and withdrawal, and the other on aggressive long-term growth [1] - Envision Early Retirement and Sensor Unlimited provide solutions for generating high income and growth with isolated risks through dynamic asset allocation [1] Group 2 - The firm provides direct access for clients to discuss investment ideas via chat, along with monthly updates on holdings and tax discussions [1] - Envision Research combines extensive experience in high-tech R&D, consulting, and portfolio management to inform its investment strategies [1]
Japan's Hisamitsu Pharmaceutical plans $2.55 billion MBO
Reuters· 2026-01-07 03:20
Core Viewpoint - Hisamitsu Pharmaceutical is planning a management buyout to take the company private for nearly 400 billion yen ($2.55 billion) [1] Company Summary - Hisamitsu Pharmaceutical aims to execute a management buyout, indicating a strategic shift towards privatization [1] - The buyout is valued at approximately 400 billion yen, equivalent to $2.55 billion, highlighting the significant financial commitment involved [1]
Crinetics Pharmaceuticals Announces Pricing of Public Offering of Common Stock
Globenewswire· 2026-01-07 02:22
Core Viewpoint - Crinetics Pharmaceuticals, Inc. has announced a public offering of 7,620,000 shares at a price of $45.95 per share, aiming to raise approximately $350 million in gross proceeds before expenses [1][2]. Group 1: Offering Details - The offering consists entirely of shares sold by Crinetics, with a 30-day option for underwriters to purchase an additional 1,143,000 shares [1]. - The expected closing date for the offering is around January 8, 2026, pending customary closing conditions [1]. Group 2: Use of Proceeds - The net proceeds from the offering will be utilized for commercial activities related to the launch of PALSONIFY™, R&D of product candidates, and general corporate purposes, including capital expenditures and working capital [2]. - Crinetics may also consider using a portion of the proceeds for in-licensing, acquiring, or investing in complementary businesses or technologies, although there are no current commitments to do so [2]. Group 3: Company Overview - Crinetics Pharmaceuticals focuses on developing novel therapeutics for endocrine diseases and related tumors, with expertise in targeting G-protein coupled receptors (GPCRs) [6]. - The company's lead product, PALSONIFY™ (paltusotine), is the first oral treatment approved by the FDA for adults with acromegaly who have not responded adequately to surgery [7]. - Crinetics has a pipeline of over 10 disclosed programs, including candidates for congenital adrenal hyperplasia and neuroendocrine tumors, addressing various endocrine conditions [7].
Sandisk, Alumis, Micron Technology, Ventyx Biosciences, And Western Digital: Why These 5 Stocks Are On Investors' Radars Today - SanDisk (NASDAQ:SNDK)
Benzinga· 2026-01-07 01:45
On Tuesday, U.S. stocks experienced a positive trading session. The Dow Jones Industrial Average climbed over 480 points, marking a 0.99% increase to 49,462.08. The NASDAQ also saw gains, rising 0.65% to 23,547.17, while the S&P 500 increased by 0.62% to 6,944.82.These are the top stocks that gained the attention of retail traders and investors throughout the day.SanDisk Corporation (NASDAQ:SNDK)SanDisk shares soared by 27.56%, closing at $349.63. The stock reached an intraday high of $352 and a low of $288 ...