Atacicept

Positive Phase 3 data from ORIGIN 3 study of atacicept in IgA nephropathy (IgAN) presented at American Society of Nephrology (ASN) Kidney Week and published in the New England Journal of Medicine U.S. Food and Drug Administration (FDA) granted priority review to Biologics License Application (BLA) for atacicept with Prescription Drug User Fee Act (PDUFA) date of July 7, 2026; potential commercial launch of atacicept expected in mid-2026 Strong balance sheet bolstered by equity and debt financings in 2025 expected to be sufficient to fund company beyond atacicept approval and U.S. commercial launch BRISBANE, Calif., Feb. 26, 2026 (GLOBE NEWSWIRE) -- Vera Therapeutics, Inc. (Nasdaq: VERA), a late clinical-stage biotechnology company focused on developing and commercializing transformative treatments for patients with serious immunological diseases, today reported its business highlights and financial results for the full year ended December 31, 2025. “In 2025, Vera Therapeutics delivered on several key milestones as we advanced atacicept toward potential FDA approval and commercialization,” said Marshall Fordyce, M.D., Founder and CEO of Vera Therapeutics. “The BLA has been granted priority review and we expect to be commercially prepared to successfully launch atacicept in IgAN in mid-2026 if approved. Our commercial team brings decades of experience launching innovative therapies and is eager to bring this potentially disease-modifying therapy to patients with IgAN and other autoimmune kidney diseases.” “Vera Therapeutics has established a leadership position within the IgAN space based on the compelling pro atacicept. Data from the ORIGIN clinical program have shown that blocking BAFF and APRIL with atacicept results in clinically meaningful reductions to proteinuria, Gd-IgA1, and hematuria (Phase 2 and 3) and a stabilization of eGFR (Phase 2),” said Robert M. Brenner, M.D., Chief Medical Officer of Vera Therapeutics. “Vera is confident in the strength of the atacicept data package to support approval and deliver a potential new therapy to the IgAN patients and caregivers whom we serve.” Key Full Year 2025 and Recent Business Highlights Positive primary endpoint results from the ORIGIN Phase 3 clinical trial of atacicept for the treatment of IgAN were presented in a featured late-breaking oral presentation during the opening plenary session of ASN Kidney Week 2025 and published in the New England Journal of Medicine FDA granted priority review to the atacicept BLA for the treatment of IgAN in adults, and assigned a PDUFA target action date of July 7, 2026; Vera Therapeutics plans for a potential commercial launch in mid-2026 Matt Skelton, Chief Commercial Officer , advancing preparations for U.S. commercial launch Appointed James R. Meyers , an accomplished biopharmaceutical executive with over three decades of commercial leadership experience, to Board of Directors Successfully completed an equity financing and entered into a debt agreement resulting in combined potential gross proceeds of $800 million, strengthening Vera Therapeutics’ balance sheet to fund operations beyond the potential approval and U.S. commercial launch of atacicept Anticipated Upcoming Milestones Potential FDA approval of atacicept in IgAN – PDUFA date of July 7, 2026 Planned U.S. commercial launch of atacicept, pending FDA approval – mid-2026 Initial results from PIONEER – a Phase 2 basket trial evaluating atacicept in expanded IgAN populations, and other autoimmune kidney diseases – expected in 1H 2026 Pivotal ORIGIN 3 study completion with two-year eGFR data – expected in 2027 Financial Results for the Year Ended December 31, 2025 For the year ended December 31, 2025, Vera Therapeutics reported a net loss of $299.6 million, or a net loss per diluted share of $4.66, compared to a net loss of $152.1 million, or a net loss per diluted share of $2.75, for the year ended December 31, 2024. During the year ended December 31, 2025, net cash used in operating activities was $241.1 million, compared to $134.7 million for the year ended December 31, 2024. Vera Therapeutics reported $714.6 million in cash, cash equivalents, and marketable securities as of December 31, 2025, which combined with availability under its debt facility, Vera Therapeutics believes to be sufficient to fund operations through potential approval and U.S. commercial launch of atacicept and beyond. About Atacicept Atacicept is an investigational recombinant fusion protein that contains the soluble transmembrane activator and calcium-modulating cyclophilin ligand interactor (TACI) receptor that binds to the cytokines B-cell activating factor (BAFF) and A PRoliferation-Inducing Ligand (APRIL). These cytokines are members of the tumor necrosis factor family that promote B-cell survival and autoantibody production associated with IgAN, lupus nephritis, and other autoimmune kidney diseases. About the Atacicept Clinical Program The ORIGIN Phase 2b clinical trial of atacicept in IgAN met its primary and key secondary endpoints, with statistically significant and clinically meaningful proteinuria reductions and stabilization of eGFR versus placebo through 36 weeks. The safety pro the randomized period was comparable between atacicept and placebo. Through 96 weeks, atacicept demonstrated further improvements in Gd-IgA1, hematuria, and proteinuria, as well as stabilization of eGFR reflecting a pro with that of the general population without IgAN. The ORIGIN Phase 3 trial met the primary endpoint with a statistically significant and clinically meaningful reduction in proteinuria at week 36, in the prespecified interim analysis. Across the ORIGIN program in IgAN, the safety pro atacicept appears favorable, and comparable to placebo. The trial continues in a placebo-controlled blinded manner to evaluate the change in kidney function over two years as measured by eGFR, with results expected in 2027. For more information about ORIGIN 3, please visit Atacicept has received FDA Breakthrough Therapy Designation for the treatment of IgAN, which reflects the FDA’s determination that, based on an assessment of data from the ORIGIN Phase 2b clinical trial, atacicept may demonstrate substantial improvement on a clinically significant endpoint over available therapies for patients with IgAN. Vera Therapeutics believes atacicept is positioned for best-in-class potential, targeting B cells to reduce autoantibodies and having been administered to more than 1,500 patients in clinical trials across different disease areas. The ORIGIN Extend study provides ORIGIN study participants with extended access to atacicept until its potential commercial availability in their region and captures longer-term safety and efficacy data. Atacicept is also being evaluated in expanded IgAN populations, anti-PLA2R positive primary membranous nephropathy, and anti-nephrin positive focal segmental glomerulosclerosis (FSGS) and minimal change disease (MCD) patients in the PIONEER trial. About Vera Therapeutics Vera Therapeutics is a late clinical-stage biotechnology company focused on developing treatments for serious immunological diseases. Vera Therapeutics’ mission is to advance treatments that target the source of disease in order to change the standard of care for patients. Vera Therapeutics’ lead product candidate is atacicept, a fusion protein self-administered at home as a subcutaneous once weekly injection that blocks both BAFF and APRIL, which stimulate B cells to produce autoantibodies contributing to certain autoimmune diseases, including IgAN and lupus nephritis. Beyond IgAN, Vera Therapeutics is evaluating additional diseases where the reduction of autoantibodies by atacicept may prove clinically meaningful. In addition, Vera Therapeutics holds an exclusive license agreement with Stanford University for a novel, next generation fusion protein targeting BAFF and APRIL, known as VT-109, with wide therapeutic potential across the spectrum of B-cell-mediated diseases. Vera Therapeutics is also evaluating development of MAU868, a monoclonal antibody designed to neutralize infection with BK virus, which can have devastating consequences in kidney transplant recipients. Vera Therapeutics retains all global developmental and commercial rights to atacicept, VT-109 and MAU868. For more information, please visit . Forward-looking Statements Statements contained in this press release regarding matters, events or results that may occur in the future are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements include statements regarding, among other things, approval of atacicept by the FDA, including expected timing; the timing, preparedness and success of the commercial launch of atacicept in the U.S.; the ability of atacicept to be a disease-modifying therapy for patients with IgAN and other autoimmune kidney diseases; Vera Therapeutics' confidence in the strength of the atacicept data package to support FDA approval; Vera Therapeutics' ability to fund operations beyond anticipated approval and U.S. commercial launch of atacicept; timing of initial results from PIONEER and completion of ORIGIN 3; atacicept’s positioning for best-in-class potential; and the plans, commitments, aspirations and goals under the caption “About Vera Therapeutics”. Words such as “anticipate,” “believe,” “expect,” “may,” “plan,” “potential,” “will” and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based upon Vera Therapeutics’ current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, which include, without limitation, risks related to the regulatory approval process, results of earlier clinical trials may not be obtained in later clinical trials, preliminary results may not be predictive of topline results, risks and uncertainties associated with Vera Therapeutics’ business in general, the impact of macroeconomic and geopolitical events, and the other risks described in Vera Therapeutics' filings with the U.S. Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made and are based on management’s assumptions and estimates as of such date. Vera Therapeutics undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by law. For more information, please contact: Investor Contact: Joyce Allaire LifeSci Advisors 212-915-2569 jallaire@lifesciadvisors.com Media Contact: Debra Charlesworth Vera Therapeutics 415-854-8051 corporatecommunications@veratx.com VERA THERAPEUTICS, INC. Condensed Statements of Operations and Comprehensive Loss (in thousands, except share and per share amounts) (Unaudited) For the Year Ended December 31, 2025 2024 Operating expenses: Research and development $ 215,256 $ 126,172 General and administrative 100,217 40,998 Total operating expenses 315,473 167,170 Loss from operations (315,473 ) (167,170 ) Other income, net 15,859 15,023 Provision for income taxes (1 ) (1 ) Net loss $ (299,615 ) $ (152,148 ) Change in fair value on marketable securities 393 142 Comprehensive loss $ (299,222 ) $ (152,006 ) Net loss per share attributable to common stockholders, basic and diluted $ (4.66 ) $ (2.75 ) Weighted-average shares used in computing net loss per share attributable to common stockholders, basic and diluted 64,233,814 55,326,680 VERA THERAPEUTICS, INC. Condensed Balance Sheets (in thousands) (Unaudited) December 31, 2025 2024 Assets Current assets: Cash, cash equivalents and marketable securities $ 714,589 $ 640,852 Prepaid expenses and other current assets 14,294 10,366 Total current assets 728,883 651,218 Operating lease right-of-use assets 1,923 3,372 Other noncurrent assets 3,927 1,091 Total assets $ 734,733 $ 655,681 Liabilities and stockholders' equity Current liabilities: Accounts payable $ 21,898 $ 7,665 Operating lease liabilities 549 1,483 Accrued expenses and other liabilities, current 31,008 16,223 Total current liabilities 53,455 25,371 Long-term debt 74,838 50,687 Operating lease liabilities, noncurrent 1,919 2,468 Total liabilities 130,212 78,526 Stockholders' equity Common stock 71 64 Additional paid-in-capital 1,364,529 1,037,948 Accumulated other comprehensive income 786 393 Accumulated deficit (760,865 ) (461,250 ) Total stockholders' equity 604,521 577,155 Total liabilities and stockholders' equity $ 734,733 $ 655,681

导言 2026 年将成为全球制药行业的重磅爆发年！据 Evaluate 最新分析，今年最受期待的十大潜在新药，到 2032 年合计年销售额有望突破459 亿美元，较 2025 年十大新药的 290 亿美元预测额大幅攀升，创下近年新高。其中肥胖与 2 型糖尿病领域的两款 GLP-1 类药物贡献超半壁江山，肿瘤、自身免疫、心血管等领域也迎来多款突破性疗法，全球药企的新一轮竞争正式拉开帷幕。 01 CagriSema：年度最重磅，年销剑指 172 亿美元 作为榜单第一名，诺和诺德的 CagriSema 是首款将司美格鲁肽（Wegovy、Ozempic 活性成分）与长效胰淀素类似物卡格列汀结合的复方制剂，每周一次注射即可实现减重与控糖双重效果。其 FDA 上市申请已于 2025 年底提交，目标适应症为合并至少一种体重相关并发症的肥胖 / 超重成人，临床试验中平均减重 22.7%，显著优于单药治疗。 尽管试验数据未达投资者 25% 以上的减重预期，曾导致诺和诺德股价下跌，但该药物的耐受性表现优异，且公司正研发高剂量版本（7.2mg 司美格鲁肽），未来减重效果有望进一步提升。Evaluate 预测，这款药物 2032 年销售额将达172 亿美元，较 2025 年榜首药物销售额翻倍。 02 Orforglipron：口服 GLP-1 新星，全球 市场成核心优势 礼来的 Orforglipron 是第二款即将获批的口服 GLP-1 受体激动剂，作为小分子药物，其生产可及性远高于诺和诺德的口服司美格鲁肽（肽类），在中印巴等肥胖人口众多的中低收入国家具备显著优势。该药物无需空腹服用，且在减重维持治疗中表现亮眼 —— 从 Wegovy 切换至该药物的患者，几乎能保持此前的减重效果。礼来预计其将于 2026 年第二季度获批，上市后将与诺和诺德展开口服 GLP-1 市场的直接竞争。Evaluate 预测其 2032 年销售额为118 亿美元，而部分分析师对其预期更高，认为 2028 年销售额即可突破 160 亿美元。 03 肿瘤领域：CAR-T 与乳腺癌疗法双突破 Anito-cel：针对复发 / 难治性多发性骨髓瘤的 CAR-T 疗法，临床试验中完全缓解率 74%、18 个月无进展生存率 67.4%，疗效优于强生 / 传奇生物的 Carvykti，且安全性更优。吉利德计划 2026 年下半年推动其上市，2032 年预测销售额25 亿美元，有望成为多发性骨髓瘤领域的新标杆。 Gedatolisib：从辉瑞引进的 PI3K/mTOR 双抑制剂，在 ER 阳性 / HER2 阴性乳腺癌二线治疗中显著延长无进展生存期，让 Celcuity 股价从 14 美元飙升至 100 美元以上。其 2032 年预测销售额21 亿美元，目前正开展 PI3K 突变型乳腺癌的临床试验，未来适应症有望进一步拓展。 Camizestrant：新一代口服 SERD 药物，针对 ESR1 突变的 HR 阳性晚期乳腺癌，临床试验中中位无进展生存期达 16 个月，较标准治疗翻倍，且能显著改善患者生活质量。阿斯利康将其定位为乳腺癌内分泌治疗的新基石，2032 年预测销售额20 亿美元，峰值销售额有望突破 50 亿美元。 04 自身免疫与罕见病：首款靶向疗法填补 临床空白 Brepocitinib：首款获批用于皮肌炎的 TYK2/JAK1 双抑制剂，临床试验疗效显著优于安慰剂，且为口服制剂，较现有激素、免疫抑制剂更具优势。美国约 7 万皮肌炎患者存在巨大未满足需求，该药物 2032 年预测销售额23 亿美元，未来还将拓展至葡萄膜炎、结节病等适应症。 Icotrokinra：全球首款靶向 IL-23 受体的口服肽类药物，针对中重度斑块状银屑病，临床试验疗效优于百时美施贵宝的 Sotyktu，且强生正开展其与注射用生物制剂的头对头试验，有望成为银屑病的一线口服疗法。其 2032 年预测销售额22 亿美元，未来还将拓展至银屑病关节炎、炎症性肠病等领域。 05 心血管与神经领域：首款创新疗法解决 多年难题 Baxdrostat：醛固酮合成酶抑制剂，针对难治性高血压，阿斯利康 2023 年以 18 亿美元收购获得，临床试验中降压效果显著，有望成为高血压治疗的新一代重磅药物。其 2032 年预测销售额20 亿美元，阿斯利康还计划将其与心衰药物 Farxiga 联用，进一步拓展市场。 Ulixacaltamide：针对特发性震颤的首款创新疗法，打破了该领域仅普萘洛尔一款获批药物的局面。尽管研发过程波折（曾因临床试验数据不佳导致股价大跌），但最终三期试验证实其能显著改善患者日常活动能力，且获 FDA 突破性疗法认定。Evaluate 预测其 2032 年销售额21 亿美元，而公司对其峰值销售额预期超 100 亿美元。 06 肾病领域：IgA 肾病迎来三款靶向疗法 竞争 Atacicept：针对 IgA 肾病的融合蛋白药物，能同时抑制 APRIL 和 BAFF 通路，减少肾脏损伤。其最大优势为免疫原性低 —— 抗药抗体发生率仅 2.1%，远低于同类药物 Voyxact（33%）。该药将于 2026 年 7 月迎来 FDA 审批决定，上市后将与大塚、福泰的药物展开三足鼎立，2032 年预测销售额17 亿美元，而分析师因同类药物定价超预期，将其峰值销售额预期上调至 37 亿美元。 07 行业展望：90% 获批率成常态，2026 将迎新药审批潮 Evaluate 的分析显示，2025 年最受期待的十大新药中，9 款均顺利获得 FDA 批准，仅赛诺菲的多发性硬化症药物折戟，这一高获批率为 2026 年新药市场奠定了信心。从赛道来看，GLP-1 类药物仍将是未来数年的核心增长引擎，而肿瘤、自身免疫领域的创新疗法正从 “小众突破” 走向 “大众市场”；同时，药企对 “被放弃的潜力药物” 的再开发（如 Gedatolisib、Baxdrostat）成为新趋势，小众 biotech 凭借差异化研发，也能在巨头环伺的市场中占据一席之地。 2026 年，随着这十大新药的陆续获批，全球制药市场将迎来新一轮的格局重构，而真正的竞争不仅在于上市速度，更在于临床价值、市场可及性与适应症拓展能力 —— 谁能真正解决患者需求，谁就能在百亿市场中站稳脚跟。 原文链接： https://www.fiercepharma.com/pharma/amgen-kyowa-ox40-divorce-roche-rnai-deal-daiichi-adc-cull -End- 点赞在看 转发 留言 欢迎您与我们互动