Daxdilimab

红斑狼疮具有复杂的临床、生物学及免疫学表现谱，既可为局限于皮肤的皮肤型红斑狼疮（cutaneous lupus erythematosus，CLE），也可作为一种可能危及生命的系统性红斑狼疮（SLE）。 约 80% 的 SLE 患者出现皮肤受累，在约 5% 的病例中 CLE 为 SLE 的首发表现。诊断需病理+免疫组化，鉴别玫瑰痤疮、皮肌炎等模仿者，本文根据最新综述[1]，总结 CLE 领域的新进展，涵盖发病机制、分类、诊断、预后及治疗策略及新兴疗法。 发病机制 CLE 的发病机制涉及环境诱因、遗传易感性以及先天性与适应性免疫失调之间复杂的相互作用。 紫外线辐射是关键环境因素，可诱导角质形成细胞死亡、释放核抗原，促进局部炎症及免疫激活，使免疫复合物形成并沉积于真表皮交界处。 自身抗体在 SLE 发病机制中发挥重要作用，并且常早于临床发病出现。在 CLE 中，有研究提出 UV 辐射可诱导角质形成细胞死亡及胞内抗原外露，随后被循环中的自身抗体识别，形成的免疫复合物进一步刺激浆细胞样树突细胞（pDC）产生 I型 IFN，尤其是 IFN-α。 分类系统 CLE 有多种分类体系，其中应用最广泛的是 Gilliam 和 Sontheimer 在 1981 年提出的临床病理分类，该体系将红斑狼疮的皮肤表现分为特异性和非特异性皮损。 特异性皮损即 CLE，病理特征为界面皮炎，并进一步分为三大临床亚型：急性 CLE（ACLE）、亚急性 CLE（SCLE）及慢性 CLE（CCLE）。 CCLE 包括盘状红斑狼疮（DLE，最常见亚型）、冻疮样狼疮、狼疮性脂膜炎及肿胀性狼疮（tumid lupus）（见图 1）。 图 1 . CLE 不同亚型的典型表现（图源参考文献） Kuhn 等在 2009 年提出将肿胀性狼疮单独归类为中间型 CLE（ICLE），原因是它与 SLE 关联较少且具有显著光敏感性。 Dan Lipsker 提出了另一种基于临床病理对应关系的分类方法。他强调，肿胀性狼疮及近半数狼疮性脂膜炎病例不存在典型的界面皮炎，故建议根据皮肤受累层次对 CLE 进行分类： ①表皮－真皮型：ACLE、SCLE、DLE、水疱性狼疮； ②真皮型：肿胀性狼疮、Jessner 淋巴细胞浸润症、丘疹结节性黏蛋白沉积症、REM 综合征； ③皮下脂肪型：狼疮性脂膜炎。 他还指出，疾病早期皮损往往难以准确分类，这一问题在临床实践中十分常见，故提出了未定类 CLE 的概念。 LE 非特异性皮损则分为血管性与非血管性表现。需要注意的是，CLE 或 SLE 患者的肢端紫癜很常见，常被过度诊断为狼疮性血管炎，在临床病理评估后，90% 以上的病例最终被诊断为 CLE（主要为 DLE 或冻疮样狼疮），4% 为抗磷脂综合征相关闭塞性血管病，仅 4% 真正属于狼疮性血管炎。 诊疗流程 在 SLE 背景下，CLE 的诊断有时仅凭临床特征即可完成，但多数情况下仍需皮肤病理证实。CLE 的典型病理表现包括不同程度的界面皮炎，其特征为基底层变性、角质形成细胞凋亡及空泡样变，同时伴有血管及附属器周围淋巴细胞浸润。PAS、CD123、阿新蓝及 MxA（黏病毒抗性蛋白 A）等免疫组化染色可帮助排除模仿疾病。 许多常见及罕见皮肤病均可模仿 CLE： 面部蝶形红斑及光敏感需与玫瑰痤疮鉴别，后者常伴脓疱、毛细血管扩张，但部分患者 ANA 及 DIF 亦可阳性，因此必要时需皮肤活检； DLE 需与银屑病、扁平苔藓、脂溢性皮炎、皮肌炎及皮肤淋巴瘤等鉴别； 冻疮样狼疮、狼疮性脂膜炎等特殊亚型，还需与血管炎、结节性红斑、淋巴细胞浸润性疾病及感染性疾病鉴别。 此外，应进一步评估是否合并 SLE、抗磷脂综合征及其他自身免疫病，以避免漏诊系统病变或误诊为单纯皮肤病。 进展风险 与 SCLE 及 CCLE 相比，ACLE 患者合并 SLE 的比例更高（见图 2）。CLE 进展为 SLE 的风险范围为 0%～42%，不同研究之间差异显著。 例如，瑞典全国队列研究显示，24% 的患者在 CLE 确诊时已合并 SLE，而 18% 的患者在 3 年内进展为 SLE；另一项多中心研究纳入 286 例孤立性 CLE 患者，结果显示 12.6% 的患者进展为 SLE，而仅 5.6% 出现严重 SLE 表现。 图 2 .由 CLE 进展为 SLE 的风险示意图（图源参考文献） 治疗策略 目前 CLE 循证医学证据仍较有限，现有指南及治疗综述多基于专家意见，先看表格。 表 1 皮肤型红斑狼疮治疗药物一览表 说明： 系统性糖皮质激素（泼尼松 0.5-1 mg/kg/d，疗程 ≤ 2-4 周）仅用于严重或广泛 CLE，不推荐长期使用。 生物制剂目前仅获批用于合并 SLE 的患者，单纯的 CLE 患者使用属超说明书。 表格中的数据均来自原文引用的研究或共识，供临床参考。 一线治疗 所有患者均推荐采取预防措施，包括：戒烟、严格防晒。对于 SCLE 患者应评估药物诱导性狼疮的可能。近年来，除普鲁卡因胺、特比萘芬及肼屈嗪等经典药物外，质子泵抑制剂（PPI）及抗 TNF 药物也逐渐成为 SCLE 常见诱因。 建议补充维生素 D，因为其在健康志愿者中已被证实具有光保护作用。此外，CLE 患者更易存在维生素 D 缺乏，补充维生素 D 与 CLE 改善相关。 一线治疗包括抗疟药（主要为羟氯喹）联合外用治疗。小型随机对照试验证实，外用糖皮质激素及外用钙调磷酸酶抑制剂均对 CLE 有效。近期系统综述显示，0.05% 氯倍他索、4% 及 2% 烟酰胺以及 0.1% 他克莫司均优于安慰剂。 对于轻度 CLE，推荐仅采用外用治疗作为一线方案，但也有研究显示，早期使用羟氯喹可降低进展为 SLE 的风险。 系统性糖皮质激素适用于严重或广泛 CLE，但在 CLE 中的疗效尚缺乏明确证据。推荐剂量为 0.5~1 mg/kg.d，疗程不超过 2~4 周。对于未合并 SLE 的患者，不推荐长期使用糖皮质激素。 若抗疟药疗效欠佳，可考虑优化方案，例如，将羟氯喹更换为氯喹；在羟氯喹或氯喹基础上联合阿的平（quinacrine）；根据血药浓度调整羟氯喹剂量。 二线及三线治疗 不同指南对于二、三线治疗推荐略有差异，尤其取决于 CLE 是否合并 SLE。需要强调的是，目前生物制剂仅获批用于合并 SLE 患者。使用免疫抑制剂时，应根据当前风湿免疫疾病免疫抑制患者指南及时更新。 甲氨蝶呤被所有 CLE 指南推荐为二线药物，有研究显示，甲氨喋呤治疗 DLE 和 SCLE 的 CLASI-50 应答率分别为 46% 和 72%；吗替麦考酚酯在所有 CLE 亚型中的 CLASI-50 应答率达到 70%。甲氨蝶呤推荐剂量为每周 15~25 mg，口服或皮下注射；口服吗替麦考酚酯剂量为 2000~3000 mg/d。 沙利度胺在 CLE 中被推荐为二线或三线药物，起效快，剂量通常为 50~100 mg/d，应注意其不良反应风险如致畸性、周围神经病变及血栓栓塞，并以最小有效剂量用药。来那度胺 5 mg/d 显示出类似疗效，CLASI-50 应答率可达 80%～88%。 阿维 A 50 mg/d 与羟氯喹 400 mg/d 的疗效相似，但羟氯喹耐受性更佳。异维 A 酸及阿利维 A 酸也在小型病例系列中显示出对 CLE 有效。在指南中，维 A 酸类主要推荐用于角化过度型 DLE。 氨苯砜被推荐为 CLE 的二线或三线药物。值得注意的是，它是目前唯一被推荐可在妊娠期或哺乳期使用的二线药物，推荐剂量为 50~150 mg/d。 生物制剂 利妥昔单抗常作为重度或难治性 SLE 患者的二线或三线治疗，但对 CLE 的治疗价值有限。贝利尤单抗可降低 SLE 整体疾病活动度并延长复发时间，还改善狼疮性肾炎。但该药对难治性 CLE 的疗效数据仍有限。 阿尼鲁单抗于 2022 年在欧洲获批用于 SLE，多项真实世界研究报道，该药对合并 SLE 的难治性 CLE 具有快速疗效，覆盖所有 CLE 亚型，包括冻疮样狼疮及狼疮性脂膜炎等罕见亚型。 新兴治疗 近年来，CLE 新型治疗药物的研发迅速扩展。目前已有多项专门针对 CLE 的 Ⅲ 期临床试验正在进行，包括： I 型干扰素通路相关治疗：阿尼鲁单抗皮下注射方案（150 mg，每周一次）Ⅲ 期研究目前正在伴有或不伴 SLE 的 CLE 患者中开展；Dazukibart 是一种中和 IFN-β 的单克隆抗体，在皮肌炎中已显示良好前景，目前正在 CLE 患者开展 Ⅱ 期临床试验。 多种靶向浆细胞样树突细胞（pDC）的药物已显示出令人鼓舞的结果，包括 litifilimab（抗BDCA2抗体）和 daxdilimab（抗ILT7抗体）。在 litifilimab 的 Ⅱ 期研究中，第 16 周时治疗组 43.6% 的患者达到 CLASI-50，而安慰剂组仅为 22%。daxdilimab 的 I 期研究显示，该药可改善 CLASI-A 评分。 TLR7/8 抑制剂 Afimetoran和enpatoran 是可逆性抑制 TLR7/8 信号通路的小分子药物。Enpatoran 在 Ⅱ 期研究中显示出良好前景，治疗组中最高 91.3% 的患者在第 16 周达到 CLASI-50。Afimetoran 在 I 期研究中耐受性良好，8 例患者中有 5 例在第 16 周时 CLASI-A 改善超过 50%。 TYK2 抑制剂 deucravacitinib（已获批用于银屑病）在 Ⅱ 期 CLE 研究中显示出较好疗效：第 16 周时 54.5% 的患者达到 CLASI-50，而安慰剂组仅为 19%。局部 JAK 抑制剂也正在研究中，例如芦可替尼、迪高替尼乳膏。 小结： CLE 的临床表现多样且有时较为复杂，因此在诊断过程中，即使患者已明确存在 CLE 或 SLE，也应始终谨慎排除 CLE 模拟疾病。 CLE 的管理需要综合性策略，包括：一般预防措施、外用治疗、抗疟药、系统性免疫抑制剂、新兴生物制剂。治疗方案应根据CLE亚型、疾病严重程度、瘢痕风险以及是否存在系统受累进行个体化制定。 特别说明 | 本文仅供医疗卫生等专业人士阅读 参考文献： [1]Chasset F, Teboul A. Update on cutaneous lupus erythematosus pathogenesis, diagnosis and management. J Eur Acad Dermatol Venereol, 2026, 40(5):782-800. 投稿：wudan1@dxy.cn 题图来源：参考文献

THOUSAND OAKS, Calif., Aug. 4, 2026 /PRNewswire/ -- Amgen (NASDAQ: AMGN) today announced financial results for the second quarter of 2026. "Our results demonstrate strong performance across our business. Our six key growth drivers grew 26% year over year, generating nearly 70% of second-quarter product sales. As we expand the potential of our existing medicines through new indications and advance the next wave of pipeline molecules through Phase 3, we remain confident in our ability to deliver growth well into the next decade," said Robert A. Bradway, chairman and chief executive officer. Key results include: For the second quarter, total revenues increased 10% to $10.1 billion in comparison to the second quarter of 2025. Product sales grew 9%, driven by volume growth. Twenty-two products delivered at least double-digit sales growth in the second quarter. Seventeen products are annualizing at more than $1 billion based on second quarter sales. GAAP earnings per share (EPS) increased 65% from $2.65 to $4.37 for the second quarter, driven by higher revenues. For the second quarter, GAAP operating income increased from $2.7 billion to $3.5 billion, and GAAP operating margin increased 6.5 percentage points to 36.8%. Non-GAAP EPS increased 4% from $6.02 to $6.29 for the second quarter, primarily driven by higher revenues, partially offset by higher operating expenses and higher income tax expense. For the second quarter, non-GAAP operating income increased from $4.3 billion to $4.6 billion, and non-GAAP operating margin decreased 0.5 percentage points to 48.4%. The Company generated $3.5 billion of free cash flow in the second quarter of 2026 versus $1.9 billion in the second quarter of 2025. The increase reflects the final repatriation tax payment in the second quarter of 2025 and current period business performance, partially offset by timing of working capital. References in this release to "non-GAAP" measures, measures presented "on a non-GAAP basis," and "free cash flow" (computed by subtracting capital expenditures from operating cash flow) refer to non-GAAP financial measures. Adjustments to the most directly comparable GAAP financial measures and other items are presented on the attached reconciliations. Refer to Non-GAAP Financial Measures below for further discussion. Product Sales Performance General Medicine Repatha® (evolocumab) sales increased 37% year-over-year to $953 million in the second quarter, driven by volume growth EVENITY® (romosozumab-aqqg) sales increased 38% year-over-year to $714 million in the second quarter, driven by volume growth. Prolia® (denosumab) sales decreased 32% year-over-year to $759 million in the second quarter, driven by 20% lower volume and 12% lower net selling price as multiple biosimilars have launched globally with more biosimilars expected. Rare Disease TEPEZZA® (teprotumumab-trbw) sales increased 14% year-over-year to $576 million in the second quarter, primarily driven by 6% higher net selling price and 6% volume growth. KRYSTEXXA® (pegloticase) sales increased 15% year-over-year to $400 million in the second quarter, driven by 23% higher net selling price, partially offset by lower inventory levels. UPLIZNA® (inebilizumab-cdon) sales increased 90% year-over-year to $335 million in the second quarter, primarily driven by volume growth. TAVNEOS® (avacopan) sales increased 36% year-over-year to $150 million in the second quarter, driven by volume growth. We continue to engage with the U.S. Food and Drug Administration (FDA) and believe that TAVNEOS demonstrates clinical effectiveness and a favorable benefit-risk profile. Inflammation TEZSPIRE® (tezepelumab-ekko) sales increased 42% year-over-year to $486 million in the second quarter, driven by volume growth. Otezla® (apremilast) sales decreased 21% year-over-year to $491 million in the second quarter, primarily driven by 9% lower net selling price and 6% lower volume. Enbrel® (etanercept) sales decreased 4% year-over-year to $580 million in the second quarter, primarily driven by 22% lower net selling price, partially offset by 16% favorable changes to estimated sales deductions. The decline in net selling price reflects the impact of U.S. Medicare Part D price setting under the Inflation Reduction Act, effective January 1, 2026, as well as an increased 340B Program mix. AMJEVITA® (adalimumab-atto)/AMGEVITA™ (adalimumab) sales increased 17% year-over-year to $155 million in the second quarter, primarily driven by volume growth. PAVBLU® (aflibercept-ayyh) sales increased 121% year-over-year to $287 million in the second quarter, primarily driven by volume growth based on its position as the only commercially available biosimilar to EYLEA ® in the U.S. during this period. Oncology BLINCYTO® (blinatumomab) sales increased 23% year-over-year to $472 million in the second quarter, primarily driven by 16% volume growth. IMDELLTRA® (tarlatamab-dlle)/IMDYLLTRA™ (tarlatamab) sales increased 115% year-over-year to $288 million in the second quarter, primarily driven by volume growth. Vectibix® (panitumumab) sales increased 11% year-over-year to $338 million in the second quarter, primarily driven by volume growth. KYPROLIS® (carfilzomib) sales decreased 17% year-over-year to $314 million in the second quarter, driven by lower volume. LUMAKRAS®/LUMYKRAS™ (sotorasib) sales increased 23% year-over-year to $111 million in the second quarter, primarily driven by volume growth. Nplate® (romiplostim) sales increased 17% year-over-year to $430 million in the second quarter, driven by 13% volume growth and higher net selling price. XGEVA® (denosumab) sales decreased 34% year-over-year to $352 million in the second quarter, primarily driven by 22% lower volume and 8% lower net selling price as multiple biosimilars have launched globally with more biosimilars expected. MVASI® (bevacizumab-awwb) sales decreased 20% year-over-year to $153 million in the second quarter, driven by 16% lower net selling price and lower volume. Established Products Our established products, which consist of Aranesp® (darbepoetin alfa), Neulasta® (pegfilgrastim), and Parsabiv® (etelcalcetide), generated $632 million of sales in the second quarter. Sales increased 19% year-over-year, driven by 15% higher net selling price and 2% volume growth. Product Sales Detail by Product and Geographic Region Operating Expense, Operating Margin and Tax Rate Analysis On a GAAP basis: Total Operating Expenses remained relatively unchanged year-over-year for the second quarter. Cost of Sales as a percentage of product sales decreased 4.8 percentage points, driven by lower amortization expense from acquisition-related assets, partially offset by higher profit share expense, higher manufacturing costs and changes in our sales mix. Research & Development (R&D) expenses increased 7% driven by higher spend in both Later-Stage Clinical Programs, primarily those related to MariTide and Marketed Product Support. Selling, General & Administrative (SG&A) expenses increased 3% driven by higher general and administrative expenses and higher commercial product-related expenses. Other operating expenses for the second quarter included litigation expenses. Operating Margin as a percentage of product sales increased 6.5 percentage points to 36.8%. Tax Rate increased 5.5 percentage points for the second quarter, primarily driven by the change in earnings mix, including lower amortization expense from acquisition-related assets. On a non-GAAP basis: Total Operating Expenses increased 11% year-over-year for the second quarter. Cost of Sales as a percentage of product sales increased 1.9 percentage points, driven by higher profit share expense, higher manufacturing costs and changes in our sales mix. R&D expenses increased 10%, primarily driven by higher spend in both Later-Stage Clinical Programs, primarily those related to MariTide, and Marketed Product Support. SG&A expenses increased 4%, primarily driven by higher general and administrative expenses and higher commercial product-related expenses. Operating Margin as a percentage of product sales decreased 0.5 percentage points for the second quarter to 48.4%. Tax Rate increased 1.4 percentage points for the second quarter, primarily driven by the change in earnings mix and net unfavorable items in the current-year period. Cash Flow and Balance Sheet The Company generated $3.5 billion of free cash flow in the second quarter of 2026 versus $1.9 billion in the second quarter of 2025. The increase reflects the final repatriation tax payment in the second quarter of 2025 and current period business performance, partially offset by timing of working capital. The Company declared a second quarter 2026 dividend on March 4, 2026 of $2.52 per share that was paid on June 5, 2026 to all stockholders of record as of May 15, 2026, representing a 6% increase from the same period in 2025. During the second quarter of 2026, there were no repurchases of shares of common stock under our stock repurchase program. Cash and cash equivalents totaled $14.0 billion and debt outstanding totaled $57.3 billion as of June 30, 2026. 2026 Guidance For the full year 2026, the Company expects: Total revenues in the range of $38.2 billion to $39.4 billion. On a GAAP basis, EPS in the range of $15.80 to $17.08, and a tax rate in the range of 14.5% to 16.0%. On a non-GAAP basis, EPS in the range of $22.30 to $23.50, and a tax rate in the range of 15.0% to 16.5%. Capital expenditures to be approximately $2.6 billion. Share repurchases not to exceed $3.0 billion. Second Quarter Product and Pipeline Update The Company provided the following updates on selected product and pipeline programs: General Medicine MariTide (maridebart cafraglutide/AMG 133) MariTide is a differentiated antibody-peptide conjugate that activates the glucagon-like peptide-1 (GLP-1) receptor and antagonizes the glucose-dependent insulinotropic polypeptide receptor (GIPR). MariTide's long-acting design supports starting with monthly dosing, and staying on MariTide with as few as 4 or 6 doses per year. MARITIME-1, a Phase 3 study of MariTide for chronic weight management, is ongoing in adults living with obesity or overweight, without Type 2 diabetes (T2D). MARITIME-2, a Phase 3 study of MariTide for chronic weight management, is ongoing in adults living with obesity or overweight, with T2D. MARITIME-CV, a Phase 3 study of MariTide on cardiovascular (CV) outcomes, is enrolling adults living with established atherosclerotic cardiovascular disease and obesity or overweight. MARITIME-HF, a Phase 3 study of MariTide on reduction of heart failure events and cardiovascular risk, is enrolling adults living with heart failure with preserved or mildly reduced ejection fraction and obesity. MARITIME-OSA-1, a Phase 3 study of MariTide, is enrolling adults living with obstructive sleep apnea on positive airway pressure therapy and living with obesity or overweight. MARITIME-OSA-2, a Phase 3 study of MariTide, is enrolling adults living with obstructive sleep apnea not on positive airway pressure therapy and living with obesity or overweight. MARITIME-SWITCH, a Phase 3 study of MariTide, is enrolling adults living with obesity or overweight who will be switching from weekly tirzepatide or weekly semaglutide to MariTide on an every eight-week or quarterly dosing schedule. MARITIME-1 EXTENSION, a Phase 3 long-term extension study of MariTide, to evaluate the maintenance of weight loss with monthly, every eight-week or quarterly dosing, is enrolling adults living with obesity or overweight without T2D who completed the MARITIME-1 study. MARITIME-2 EXTENSION, a Phase 3 long-term extension study of MariTide, to evaluate the maintenance of weight loss with monthly and every eight-week dosing, is enrolling adults living with obesity or overweight with T2D who completed the MARITIME-2 study. Three Phase 3 studies of MariTide in people living with T2D will be initiated in 2026. A Phase 2b study of MariTide to assess the effect of MariTide on liver fat reduction and weight loss is enrolling adults living with obesity or overweight with elevated liver fat. AMG 513 Future development of AMG 513 will be discontinued. A Phase 1 study of AMG 513 in adults living with obesity will remain ongoing to follow enrolled participants through completion of the study. Repatha In May, results from a new analysis of the Phase 3 VESALIUS-CV pre-cardiovascular event trial in a subgroup of patients who had a prior percutaneous coronary intervention (PCI) were presented at the European Paris Course on Revascularization (EuroPCR) and simultaneously published in Circulation. In this subset of 3,627 patients who had prior PCI, Repatha: demonstrated a 30% relative reduction in the risk of a composite of coronary heart disease death, heart attack or ischemic stroke (3-P MACE). demonstrated an 18% relative reduction in a broader composite that also included ischemia-driven revascularization (4-P MACE). reduced the relative risk of heart attack by 50%, with the effect seen as soon as 6 months after randomization. was associated with nominal 34% decreased risk of cardiovascular death and 24% decreased risk of all-cause death. In June, results from a new analysis of VESALIUS-CV in a subgroup of patients with high-risk diabetes with and without known atherosclerosis were presented at the American Diabetes Association Scientific Sessions and simultaneously published in Diabetes Care. In this subset of 6,002 patients with high-risk diabetes with and without known atherosclerosis, Repatha: demonstrated a 29% relative reduction in the risk of a composite of coronary heart disease death, heart attack or ischemic stroke (3-P MACE). demonstrated a 21% relative reduction in a broader composite that also included ischemia-driven revascularization (4-P MACE). was associated with a nominal 21% decreased risk of all-cause death. Further data from three new pre-specified analyses of the VESALIUS-CV study demonstrating the protective effects of Repatha on total cardiovascular events, myocardial infarction and fatal outcomes, will be presented as oral abstracts at the European Society of Cardiology (ESC) Congress in August 2026. EVOLVE-MI, a Phase 4 study of Repatha initiated within 10 days of an acute myocardial infarction to reduce the risk of cardiovascular events, is ongoing. Olpasiran (AMG 890) Olpasiran is a potentially best-in-class small interfering ribonucleic acid (siRNA) molecule that reduces lipoprotein(a) (Lp(a)) synthesis in the liver. The OCEAN(a)-Outcomes trial, a Phase 3 secondary prevention CV outcomes study, is ongoing in patients with established atherosclerotic CV disease and elevated Lp(a). The OCEAN(a)-PreEvent trial, a Phase 3 primary prevention CV outcomes study, is enrolling patients with elevated Lp(a) at high risk for a first major CV event. The OCEAN(a)-Coronary Computed Tomography Angiography (CCTA), a Phase 3 coronary artery plaque study, is enrolling patients with atherosclerotic CV disease and elevated Lp(a). Rare Disease UPLIZNA In June, new open-label extension data from the Phase 3 MITIGATE study in patients with immunoglobulin G4-related disease (IgG4-RD) were presented at the European Alliance of Associations for Rheumatology (EULAR) 2026 Congress. Key findings included: sustained response and disease control with continued UPLIZNA treatment at Year 1 of the open label period (OLP). 100% of patients remained flare-free and 71.4% of patients achieved both flare-free and glucocorticoid-free complete remission with continued UPLIZNA treatment through Year 1 of the OLP. UPLIZNA continued to demonstrate a safety profile consistent with the established safety profile of UPLIZNA across all approved indications. efficacy and safety outcomes support the longer-term use of UPLIZNA for the treatment of IgG4-RD. MERCURY, a Phase 2/3 study of UPLIZNA, was initiated in patients with autoimmune hepatitis (AIH). A Phase 3 study of UPLIZNA in patients with chronic inflammatory demyelinating polyneuropathy (CIDP) will be initiated H2 2026 - H1 2027. TEPEZZA A Phase 3 study of TEPEZZA in Japan is ongoing in patients with chronic/low clinical activity score thyroid eye disease (TED). TAVNEOS TAVNEOS (avacopan), a product the Company acquired in connection with its acquisition of ChemoCentryx, Inc. in 2022, was approved by the FDA in October 2021. TAVNEOS is indicated for the adjunctive treatment of adult patients with severe active anti-neutrophil cytoplasmic autoantibody (ANCA)-associated vasculitis (AAV) in combination with standard therapy including glucocorticoids. The Company continues to engage the FDA regarding the Center for Drug Evaluation and Research's request to voluntarily withdraw TAVNEOS from the U.S. market. On June 1, 2026, the Company requested a hearing to discuss this topic and submitted supporting materials to the FDA on July 23, 2026. The Company believes that these materials support a favorable benefit-risk profile of TAVNEOS for patients with AAV. A Phase 3, open-label study of TAVNEOS in combination with rituximab or a cyclophosphamide-containing regimen, has completed enrollment of patients from 6 years to < 18 years of age with active AAV (Granulomatosis with Polyangiitis (GPA)/Microscopic Polyangiitis (MPA)). Dazodalibep Dazodalibep is a fusion protein that inhibits CD40 ligand (CD40L). Two Phase 3 studies of dazodalibep in Sjögren's disease are underway. The first study is ongoing in patients with moderate-to-severe systemic disease activity. The second study is ongoing in patients with moderate to high symptom burden with low systemic disease activity. Completion of both studies is expected in H2 2026. Daxdilimab Daxdilimab is a first-in-class plasmacytoid dendritic cell (pDC) depleting monoclonal antibody targeting immunoglobulin-like transcript 7 (ILT7). The Company is taking steps to advance daxdilimab to a registrational phase of development. AMG 732 AMG 732 is an insulin-like growth factor-1 receptor (IGF-1R) targeting monoclonal antibody. A Phase 2 study of AMG 732 has completed enrollment of patients with moderate-to-severe active TED. Inflammation TEZSPIRE A Phase 3 study of TEZSPIRE is ongoing in patients with eosinophilic esophagitis. Study completion is expected in H2 2026. Two Phase 3 studies of TEZSPIRE are enrolling adults with moderate to very severe chronic obstructive pulmonary disease (COPD) and a blood eosinophil count (BEC) ≥ 150 cells/µL. Blinatumomab Blinatumomab is a bispecific T-cell engager (BiTE®) molecule targeting CD19. A Phase 2 study of blinatumomab in autoimmune disease is enrolling adults with refractory rheumatoid arthritis. A Phase 2 study of blinatumomab in autoimmune disease is ongoing in adults with systemic lupus erythematosus (SLE) with and without nephritis. Inebilizumab Inebilizumab is a B-cell depleting monoclonal antibody targeting CD19. A Phase 2 study of inebilizumab in autoimmune disease is enrolling adults with SLE with nephritis. Sunakiment (AMG 104/AZD8630) Sunakiment is an inhaled anti-thymic stromal lymphopoietin (TSLP) fragment antigen-binding (Fab) protein. LEVANTE, a Phase 2 study of sunakiment in patients with asthma, is complete. The results of this dose-ranging study were encouraging and informative for dose selection. In collaboration with AstraZeneca, the Company is planning a Phase 3 development program in asthma. Oncology BLINCYTO/blinatumomab Golden Gate, a Phase 3 study of BLINCYTO alternating with low-intensity chemotherapy, has completed enrollment of older adult patients with newly diagnosed CD19-positive Ph-negative B-cell precursor acute lymphoblastic leukemia (B-ALL). A potentially registration-enabling Phase 2 study of subcutaneous blinatumomab in both adults and adolescents with relapsed or refractory CD19-positive Philadelphia chromosome (Ph) negative B-ALL has paused enrollment of new patients following a partial clinical hold by the FDA. A Phase 1b/2 study of subcutaneous blinatumomab in pediatric patients with relapsed or refractory and minimal residual disease positive (MRD+) B-ALL has paused enrollment of new patients following a partial clinical hold by the FDA. Discussions are underway with the FDA on a path forward to reopen both subcutaneous blinatumomab studies. IMDELLTRA/tarlatamab IMDELLTRA is the first and only FDA-approved delta-like ligand 3 (DLL3) targeting BiTE molecule. In May, the European Commission approved IMDYLLTRA as a monotherapy for the treatment of adults with extensive-stage small cell lung cancer (ES-SCLC) who require systemic therapy following disease progression on or after first-line platinum-based chemotherapy. Also in May, the China National Medical Products Administration (NMPA) granted full approval to IMDELLTRA for the treatment of second-line ES-SCLC and will be commercialized by BeOne in China. The Company is advancing a comprehensive, global clinical development program across extensive-stage (ES) and limited-stage (LS) SCLC: DeLLphi-303, a Phase 1b study of IMDELLTRA in combination with a programmed cell death protein ligand-1 (PD-L1) inhibitor, carboplatin and etoposide or separately in combination with a PD-L1 inhibitor alone, is ongoing in patients with first-line ES-SCLC. DeLLphi-305, a Phase 3 study of IMDELLTRA and durvalumab, is ongoing in first-line ES-SCLC in the maintenance setting. DeLLphi-306, a Phase 3 study of IMDELLTRA following concurrent chemoradiation therapy, is ongoing in patients with LS-SCLC. DeLLphi-308, a Phase 1b study evaluating subcutaneous tarlatamab, is enrolling patients with second-line or later ES-SCLC. DeLLphi-309, a Phase 2 study evaluating alternative intravenous dosing regimens of IMDELLTRA, has completed its primary analysis. The primary analysis demonstrated that extended dosing intervals can result in durable responses with encouraging survival, with a safety profile in line with expectation. The Company will discuss these new data with regulators and detailed results will be presented at an upcoming medical congress. DeLLphi-310, a Phase 1b study of IMDELLTRA in combination with YL201, a B7-H3 targeting antibody-drug conjugate (ADC), with or without a PD-L1 inhibitor, has completed enrollment of patients with ES-SCLC. DeLLphi-311, a Phase 1b study of IMDELLTRA in combination with etakafusp alfa (AB248), a novel CD8+ T-cell selective interleukin-2 (IL-2), is enrolling patients with second-line or later ES-SCLC. DeLLphi-312, a Phase 3 study of IMDELLTRA in combination with carboplatin, etoposide and durvalumab, is enrolling patients with first-line ES-SCLC. DeLLphi-313, a Phase 1b study of IMDELLTRA in combination with zocilurtatug pelitecan, a DLL3 targeting ADC, with and without a PD-L1 inhibitor, is enrolling patients with ES-SCLC DeLLphi-315, a Phase 3 study of subcutaneous tarlatamab, was initiated in patients with second-line ES-SCLC. Xaluritamig (AMG 509) Xaluritamig is a first-in-class BiTE molecule targeting six-transmembrane epithelial antigen of the prostate 1 (STEAP1). XALute, a Phase 3 study of xaluritamig, has completed enrollment of patients with metastatic castration-resistant prostate cancer (mCRPC) who have previously been treated with taxane-based chemotherapy. XALience, a Phase 3 study of xaluritamig in combination with abiraterone, is enrolling patients with chemotherapy-naïve mCRPC. A Phase 1 study of xaluritamig monotherapy and xaluritamig in combination with abiraterone is enrolling patients with mCRPC who have not yet received taxane-based chemotherapy. This study is ongoing in patients with mCRPC who have previously received taxane-based chemotherapy in a fully outpatient treatment setting to further improve administration convenience. A Phase 1b study of neoadjuvant xaluritamig therapy prior to radical prostatectomy is enrolling patients with newly diagnosed localized intermediate or high–risk prostate cancer. A Phase 1b study of xaluritamig is ongoing in patients with high-risk biochemically recurrent prostate cancer after definitive therapy. A Phase 1b study of xaluritamig in combination with androgen receptor pathway inhibitors is enrolling patients with metastatic hormone-sensitive prostate cancer. A Phase 1b study of xaluritamig is enrolling adults with mCRPC to evaluate an additional dosing regimen. A Phase 1b study of xaluritamig is enrolling adult, adolescent and pediatric patients with relapsed or refractory Ewing sarcoma. LUMAKRAS/LUMYKRAS CodeBreaK 301, a Phase 3 study of LUMAKRAS in combination with Vectibix and FOLFIRI vs. FOLFIRI with or without bevacizumab-awwb, is enrolling patients with first-line KRAS G12C–mutated metastatic colorectal cancer. CodeBreaK 202, a Phase 3 study of LUMAKRAS plus platinum doublet chemotherapy vs. pembrolizumab plus chemotherapy, is enrolling patients with first-line KRAS G12C–mutated and PD-L1 negative advanced non-small cell lung cancer (NSCLC). Nplate PROCLAIM, a Phase 3 study of Nplate for the treatment of chemotherapy-induced thrombocytopenia (CIT), is ongoing in patients with NSCLC, ovarian cancer or breast cancer. ROMISTER, a Phase 3 study of Nplate plus predniso(lo)ne compared with predniso(lo)ne alone, was initiated in patients with untreated primary immune thrombocytopenia (ITP). Biosimilars A randomized, double-blind comparative clinical study of ABP 206 compared with OPDIVO® (nivolumab) is ongoing in patients with treatment-naïve unresectable or metastatic melanoma. A randomized, double-blind pharmacokinetic similarity study of ABP 234 compared with KEYTRUDA® (pembrolizumab) is ongoing in patients with early-stage non-squamous NSCLC as adjuvant treatment. A randomized, double-blind combined pharmacokinetic/comparative clinical study of ABP 234 compared with KEYTRUDA is ongoing in patients with advanced or metastatic non-squamous NSCLC. A randomized, double-blind, pharmacokinetic similarity/comparative clinical study of ABP 692 compared with OCREVUS® (ocrelizumab) has completed enrollment of patients with relapsing-remitting multiple sclerosis. A randomized, double-blind, comparative clinical study of ABP 938 (8 mg) compared with EYLEA HD® (aflibercept) was initiated and is enrolling patients with neovascular age-related macular degeneration. TEZSPIRE is being developed in collaboration with AstraZeneca. Sunakiment (AMG 104/AZD8630) is being developed in collaboration with AstraZeneca. Xaluritamig, formerly AMG 509, is being developed pursuant to a research collaboration with Xencor, Inc. YL201 is an investigational B7-H3 targeting antibody-drug conjugate being developed by MediLink. Zocilurtatug pelitecan is an investigational DLL3 targeting antibody-drug conjugate being developed by Zai Lab Limited. Etakafusp alfa (AB248) is a novel CD8+ T cell selective IL-2 being developed by Asher Biotherapeutics. OPDIVO is a registered trademark of Bristol-Myers Squibb Company. KEYTRUDA is a registered trademark of Merck & Co., Inc. OCREVUS is a registered trademark of Genentech, Inc. EYLEA HD is a registered trademark of Regeneron Pharmaceuticals, Inc. Non-GAAP Financial Measures In this news release, management has presented its operating results for the second quarters of 2026 and 2025, in accordance with U.S. Generally Accepted Accounting Principles (GAAP) and on a non-GAAP basis. In addition, management has presented its full year 2026 EPS and tax guidance in accordance with GAAP and on a non-GAAP basis. These non-GAAP financial measures are computed by excluding certain items related to acquisitions, restructuring and certain other items from the related GAAP financial measures. Management has presented Free Cash Flow (FCF), which is a non-GAAP financial measure, for the second quarters of 2026 and 2025. FCF is computed by subtracting capital expenditures from operating cash flow, each as determined in accordance with GAAP. The Company believes that its presentation of non-GAAP financial measures provides useful supplementary information to and facilitates additional analysis by investors. The Company uses certain non-GAAP financial measures to enhance an investor's overall understanding of the financial performance and prospects for the future of the Company's normal and recurring business activities by facilitating comparisons of results of normal and recurring business operations among current, past and future periods. The Company believes that FCF provides a further measure of the Company's liquidity. The Company uses the non-GAAP financial measures set forth in the news release in connection with its own budgeting and financial planning internally to evaluate the performance of the business, including to allocate resources and to evaluate results relative to incentive compensation targets. The non-GAAP financial measures are in addition to, not a substitute for, or superior to, measures of financial performance prepared in accordance with GAAP. About Amgen Amgen discovers, develops, manufactures and delivers innovative medicines to fight some of the world's toughest diseases. Harnessing the best of biology and technology, Amgen reaches millions of patients with its medicines. More than 45 years ago, Amgen helped establish the biotechnology industry at its U.S. headquarters in Thousand Oaks, California, and it remains at the cutting edge of innovation, using technology and human genetic data to push beyond what is known today. Amgen is advancing a broad and deep pipeline and portfolio of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases and obesity and obesity-related conditions. Amgen has been consistently recognized for innovation and workplace culture, including honors from Fast Company and Forbes. Amgen is one of the 30 companies that comprise the Dow Jones Industrial Average®, and it is also part of the Nasdaq-100 Index®, which includes the largest and most innovative non-financial companies listed on the Nasdaq Stock Market based on market capitalization. For more information, visit Amgen.com and follow Amgen on X, LinkedIn, Instagram, YouTube, Facebook, TikTok and Threads. Forward-Looking Statements This news release contains forward-looking statements that are based on the current expectations and beliefs of Amgen. All statements, other than statements of historical fact, are statements that could be deemed forward-looking statements, including any statements on the outcome, benefits and synergies of collaborations, or potential collaborations, with any other company (including BeOne Medicines Ltd.), the performance of Otezla® (apremilast), our acquisitions of ChemoCentryx, Inc., Dark Blue Therapeutics, Ltd. or Horizon Therapeutics plc (including the prospective performance and outlook of Horizon's business, performance and opportunities, and any potential strategic benefits, synergies or opportunities expected as a result of such acquisition), as well as estimates of revenues, operating margins, capital expenditures, cash, other financial metrics, expected legal, arbitration, political, regulatory or clinical results or practices, customer and prescriber patterns or practices, reimbursement activities and outcomes, effects of pandemics or other widespread health problems on our business, outcomes, progress, and other such estimates and results. Forward-looking statements involve significant risks and uncertainties, including those discussed below and more fully described in the Securities and Exchange Commission reports filed by Amgen, including our most recent annual report on Form 10-K and any subsequent periodic reports on Form 10-Q and current reports on Form 8-K. Unless otherwise noted, Amgen is providing this information as of the date of this news release and does not undertake any obligation to update any forward-looking statements contained in this document as a result of new information, future events or otherwise. No forward-looking statement can be guaranteed and actual results may differ materially from those we project. Our results may be affected by our ability to successfully market both new and existing products domestically and internationally, clinical and regulatory developments involving current and future products, sales growth of recently launched products, competition from other products including biosimilars, difficulties or delays in manufacturing our products and global economic conditions, including those resulting from geopolitical relations and government actions. In addition, sales of our products are affected by pricing pressure, political and public scrutiny and reimbursement policies imposed by third-party payers, including governments, private insurance plans and managed care providers and may be affected by regulatory, clinical and guideline developments and domestic and international trends toward managed care and healthcare cost containment. Furthermore, our research, testing, pricing, marketing and other operations are subject to extensive regulation by domestic and foreign government regulatory authorities. We or others could identify safety, side effects or manufacturing problems with our products, including our devices, after they are on the market. Our business may be impacted by government investigations, litigation and product liability claims. In addition, our business may be impacted by the adoption of new tax legislation or exposure to additional tax liabilities. Further, while we routinely obtain patents for our products and technology, the protection offered by our patents and patent applications may be challenged, invalidated or circumvented by our competitors, or we may fail to prevail in present and future intellectual property litigation. We perform a substantial amount of our commercial manufacturing activities at a few key facilities, including in Puerto Rico, and also depend on third parties for a portion of our manufacturing activities, and limits on supply may constrain sales of certain of our current products and product candidate development. An outbreak of disease or similar public health threat, and the public and governmental effort to mitigate against the spread of such disease, could have a significant adverse effect on the supply of materials for our manufacturing activities, the distribution of our products, the commercialization of our product candidates, and our clinical trial operations, and any such events may have a material adverse effect on our product development, product sales, business and results of operations. We rely on collaborations with third parties for the development of some of our product candidates and for the commercialization and sales of some of our commercial products. In addition, we compete with other companies with respect to many of our marketed products as well as for the discovery and development of new products. Discovery or identification of new product candidates or development of new indications for existing products cannot be guaranteed and movement from concept to product is uncertain; consequently, there can be no guarantee that any particular product candidate or development of a new indication for an existing product will be successful and become a commercial product. Further, some raw materials, medical devices and component parts for our products are supplied by sole third-party suppliers. Certain of our distributors, customers and payers have substantial purchasing leverage in their dealings with us. The discovery of significant problems with a product similar to one of our products that implicate an entire class of products could have a material adverse effect on sales of the affected products and on our business and results of operations. Our efforts to collaborate with or acquire other companies, products or technology, and to integrate the operations of companies or to support the products or technology we have acquired, may not be successful, and may result in unanticipated costs, delays or failures to realize the benefits of the transactions. A breakdown, cyberattack or information security breach of our information technology systems could compromise the confidentiality, integrity and availability of our systems and our data. Our stock price is volatile and may be affected by a number of events. Our business and operations may be negatively affected by the failure, or perceived failure, of achieving our sustainability objectives. The effects of global climate change and related natural disasters could negatively affect our business and operations. Global economic conditions may magnify certain risks that affect our business. Our business performance could affect or limit the ability of our Board of Directors to declare a dividend or our ability to pay a dividend or repurchase our common stock. We may not be able to access the capital and credit markets on terms that are favorable to us, or at all. CONTACT: Amgen, Thousand Oaks Elissa Snook, 609-251-1407 (media) Annik Allen, 917-288-9136 (media) Casey Capparelli, 805-447-1746 (investors) Our GAAP diluted EPS guidance does not include the effect of GAAP adjustments triggered by events that may occur subsequent to this press release such as acquisitions, asset impairments, litigation, changes in fair value of our contingent consideration obligations and changes in fair value of our equity investments. SOURCE Amgen 21% more press release views with Request a Demo