Key Takeaways Roche's FDA filing for giredestrant in ER-positive breast cancer accepted, with a Dec. 18, 2026 action date.RHHBY's phase III evERA study showed a 44% lower progression risk in ITT and 62% in ESR1-mutated patients.Roche plans more filings as giredestrant advances across five phase III studies in multiple settings.Roche (RHHBY) announced that the FDA has accepted its new drug application (NDA) for giredestrant, an investigational oral therapy, in combination with everolimus, for the treatment o ...

罗氏在2026年初有10个关键分子进入三期临床开发阶段，涉及肿瘤学、免疫学等领域，其中肥胖症双 GLP-1/GIP受体激动剂CT-388的二期临床结果显示积极数据。 业绩经营情况 来源：经济观察网 经济观察网 近期动态与关注点 根据罗氏集团（RHHBY.US）于2026年1月29日发布的2025年全年财务业 绩报告，公司近期值得关注的动态包括： 产品研发进展 2025年销售额达615.16亿瑞士法郎（同比增长7%），董事会提议提高股息至每股9.80瑞士法郎，若获批 准将是连续第39年增息。 以上内容基于公开资料整理，不构成投资建议。 ...

The biotech space this week witnessed significant key milestones, including FDA approvals, NDA path-setting meetings, rejections, licensing agreements, and oncology drug acquisitions. The clinical trial arena achieved positive results in therapeutic areas such as idiopathic nephrotic syndrome, age-related macular degeneration, ulcerative colitis, plaque psoriasis, obesity, autoimmune and inflammatory diseases.Let us unpack the key developments and milestones of this week. FDA Approvals & Rejections NRx Pha ...

Core Viewpoint - The FDA has approved the combination of Venclexta® (venetoclax) and acalabrutinib for treating previously untreated adults with chronic lymphocytic leukemia (CLL), marking a significant advancement for newly diagnosed patients [1] Company Summary - Genentech, part of the Roche Group, announced the FDA approval based on the Phase III AMPLIFY study results [1]

Core Viewpoint - Genentech, a member of the Roche Group, has received FDA acceptance for its New Drug Application for giredestrant, an investigational oral therapy for specific breast cancer patients [1] Group 1: Drug Development - The New Drug Application is for giredestrant, which is intended to be used in combination with everolimus [1] - The target patient population includes adult patients with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2-negative, ESR1-mutated locally advanced or metastatic breast cancer [1]

Core Viewpoint - Roche's giredestrant, in combination with everolimus, has received FDA acceptance for a New Drug Application aimed at treating advanced ER-positive breast cancer, with a decision expected by December 18, 2026 [1][5]. Group 1: Clinical Efficacy - The phase III evERA Breast Cancer study demonstrated that giredestrant plus everolimus reduced the risk of disease progression or death by 44% in the intention-to-treat (ITT) population and by 62% in the ESR1-mutated population compared to standard-of-care therapy [2][5]. - In the ESR1-mutated population, the median progression-free survival (PFS) was 9.99 months for giredestrant compared to 5.45 months for the comparator arm, while in the ITT population, the median PFS was 8.77 months versus 5.49 months [2][5]. - Overall survival data showed a positive trend in both ITT (HR=0.69) and ESR1-mutated populations (HR=0.62), although data were immature at the time of analysis [2][5]. Group 2: Treatment Context - ER-positive breast cancer accounts for approximately 70% of breast cancer cases, and resistance to endocrine therapies is a significant challenge, particularly after CDK4/6 inhibitor treatment [3][8]. - Giredestrant's oral combination therapy aims to address treatment resistance by targeting different signaling pathways, potentially improving patient quality of life by eliminating the need for injections [3][8]. Group 3: Future Developments - Roche plans to submit additional phase III data from the lidERA study for early-stage breast cancer to health authorities worldwide, including the FDA [3][6]. - The persevERA readout in first-line ER-positive breast cancer is anticipated in the first half of the year, which will further support giredestrant's role in treatment [3][6]. Group 4: Company Commitment - Roche has a comprehensive clinical development program for giredestrant, reflecting its commitment to providing innovative treatments for patients with ER-positive breast cancer across various settings [4][9].

来源：经济观察网 经济观察网 根据截至2026年2月20日的公开信息，罗氏公司（RHHBY.US / ROG.SW）近期值得关注的 事件主要围绕财务业绩、研发管线进展及市场动态展开： 业绩经营情况 2025年财报发布：罗氏于2026年1月29日公布2025年全年业绩，销售额达615.16亿瑞士法郎（约744亿美 元），按恒定汇率计算增长7%，核心营业利润增长13%。公司预计2026年销售额将实现中个位数增 长。股息提议：董事会提议将每股股息提高至9.80瑞士法郎，若获批准，将是连续第39年增加股息。 产品研发进展 新药申报与数据读出：2026年计划申报3款新分子实体（NMEs）并推出2项关键适应症。重点包括减重 药物CT-388的III期数据（48周体重减轻22.5%）、多发性硬化症药物fenebrutinib的III期结果，以及 giredestrant在乳腺癌领域的进展。减重领域布局：罗氏目标成为全球减重领域前三，2026年将公布5款 NMEs的III期数据，涉及GLP-1/GIP双重激动剂等。 行业政策现状 医保目录纳入：2025年12月，罗氏三款创新药（伊那利塞片、格菲妥单抗注射液等）首次纳入中国国家 ...

经济观察网 近期，罗氏在诊断试剂获批、药物研发及人事任命方面取得多项进展，同时股价表现稳 健。 近期事件 基于实时行情，罗氏股价近一周表现稳健上行。区间累计涨幅3.08%，振幅3.75%，最高价60.22美元（2 月17日），最低价58.05美元（2月12日）。具体日波动：2月12日收盘58.61美元（涨1.42%），2月13日 收58.51美元（跌0.17%），2月17日收60.10美元（涨2.72%），2月18日收59.57美元（跌0.88%）。5日涨 跌幅达4.82%，年初至今累计上涨15.51%，成交金额较低（日均换手率约0.02%），但韧性凸显，同期 制药板块下跌1.31%，纳斯达克指数跌1.82%。 机构观点 机构对罗氏管线价值保持关注。TD Cowen于2026年2月11日发布报告，维持罗氏"持有"评级，目标价67 美元，认为其在肿瘤和神经科学领域的研发进展支撑长期潜力，但提示需关注专利到期风险。 以上内容基于公开资料整理，不构成投资建议。 2026年2月16日/17日，罗氏宣布其核心产品Gazyva/Gazyvaro（奥滨尤妥珠单抗）在原发性膜性肾病的全 球III期MAJESTY研究中达到主要 ...

Core Insights - Halozyme Therapeutics (HALO) reported a fourth-quarter 2025 adjusted loss of 24 cents per share, significantly below the Zacks Consensus Estimate of earnings of $2.15, and down from adjusted earnings of $1.26 per share in the same quarter last year [1][6] - The decline in earnings was primarily attributed to a $2.42 per share unfavorable impact from acquired IPR&D expenses related to the Surf Bio acquisition [1] Revenue Performance - Total revenues for the fourth quarter increased by 52% year over year to $451.8 million, surpassing the Zacks Consensus Estimate of $449 million [2] - The growth in revenue was driven by increased product sales and higher royalty payments, with royalty revenues totaling $258 million, up 51% from the previous year [4][6] Product Sales and Royalties - Product sales reached $122.7 million in the fourth quarter, reflecting a 54.5% increase year over year, although it fell short of the model estimate of $123.2 million [7] - Revenues under collaborative agreements were $71.1 million, marking a 47.5% year-over-year increase [7] Financial Metrics - Adjusted EBITDA for the quarter was $21.9 million, a significant decrease from $195.8 million in the same quarter last year [8] - As of December 31, 2025, the company had cash, cash equivalents, and marketable securities totaling $145.4 million, down from $702 million as of September 30, 2025 [8] Full-Year Results and Guidance - For the full year 2025, Halozyme generated revenues of $1.39 billion, a 38% increase year over year, with adjusted earnings of $4.15 per share, down from $4.23 per share in the previous year [9] - The company expects total revenues for 2026 to be between $1.71 billion and $1.81 billion, indicating year-over-year growth of 22% to 30% [10] - Royalty revenues for 2026 are anticipated to be in the range of $1.13 billion to $1.17 billion, reflecting a year-over-year growth of 30% to 35% [10] Future Expectations - Adjusted EBITDA for 2026 is projected to be between $1.125 billion and $1.205 billion, representing a year-over-year increase of 71% to 83% [11] - Adjusted earnings per share for 2026 are expected to be in the range of $7.75 to $8.25, indicating growth of 87% to 99% year over year [11] - Management anticipates a 5% to 10% decrease in royalty revenues for the first quarter of 2026 compared to the fourth quarter of 2025 due to annual contract rate adjustments [12]

Core Insights - Roche announced that the phase III MAJESTY study for Gazyva®/Gazyvaro® (obinutuzumab) in adults with primary membranous nephropathy met its primary endpoint, demonstrating statistically significant results in achieving complete remission at two years compared to tacrolimus [1][2] Group 1: Study Results - The MAJESTY study showed that significantly more patients achieved complete remission at 104 weeks with Gazyva/Gazyvaro compared to tacrolimus [1] - Key secondary endpoints also indicated statistically significant benefits in overall remission (complete or partial) at week 104 and complete remission at week 76 [2] Group 2: Disease Context - Primary membranous nephropathy is a chronic autoimmune condition affecting nearly 88,000 people in the EU and over 96,000 in the US, with up to 30% of patients developing kidney failure within 10 years [4][10] - The condition leads to significant health system costs and impacts on patients and families due to the need for invasive interventions like dialysis or transplant [4] Group 3: Treatment Implications - If approved, Gazyva/Gazyvaro would be the first therapy specifically indicated for primary membranous nephropathy, addressing a significant unmet need in treatment options [2][4] - The drug has shown potential in maintaining kidney function longer and preventing life-threatening complications associated with the disease [2][4] Group 4: Company Pipeline and Strategy - Gazyva/Gazyvaro is already approved for treating adults with active lupus nephritis and is being investigated in a global phase II study for children and adolescents with lupus nephritis [6] - Roche has a broad pipeline aimed at addressing immune-mediated and kidney-related diseases, with over 10 phase II-III clinical studies ongoing [11]