Naxitamab

8月5日，专注于罕见病和医疗紧急情况药物的全球特种制药公司SERB Pharmaceuticals和专注于癌症抗体治疗药物开发和商业化的商业级生物制药公司Y-mAbs Therapeutics（Nasdaq:YMAB）宣布已达成最终合并协议，SERB将收购Y-mAbs，包括其主要商业化肿瘤资产DANYELZA®（naxit amab-gqgk）(赛生药业拥有大中华区权益)，在一项全现金交易中Y-mAbs的股权价值约为4.12亿美元。交易完成后Y-mAbs的股票将不再在纳斯达克交易所上市。该交易预计将于2025年第四季度完成。 根据合并协议的条款，SERB将开始全现金要约收购Y-mAbs普通股的所有已发行股份。Y-mAbs普通股的持有人将获得每股8.60美元的现金，比Y-mAbs在2025年8月4日（交易公告前的最后一个完整交易日）的收盘价溢价约105%。 在外部顾问的协助下，Y-mAbs董事会审查了为Y-mAbs股东实现价值最大化的战略选择后，一致批准了该交易。该过程包括与众多潜在买家单独讨论Y-mAb或DANYELZA或放射性制药业务。此外，董事会审查了额外资本的潜在来源，以支持加快公司管线的进一步发展。 Y-mAbs专注于儿科肿瘤学，成功开发并商业化了抗GD2疗法DANYELZA（naxitamab gqgk）。DANYELZA是FDA批准的第一种治疗复发或难治性高风险神经母细胞瘤（一种罕见和侵袭性的癌症儿科癌症）的治疗方法，并在美国根据总体反应率和反应持续时间加速批准。DANYELZA适用于治疗一岁及以上的儿科患者，以及对先前治疗有部分反应、轻微反应或疾病稳定的复发或难治性高危神经母细胞瘤患者。除了住院使用外，医生还可以选择在门诊环境中给药DANYELZA，这可能会减轻患者及其家属的后勤负担。Y-mAbs的产品组合还包括一种针对实体瘤中GD2和循环肿瘤中CD38的研究性疗法，该疗法正在其自组装拆卸（“SADA”）预靶向放射免疫治疗平台（“PRIT”）的1期临床试验中进行。 SERB首席执行官Vanessa Wolfeler表示：“高风险神经母细胞瘤不仅是一种罕见的、毁灭性的癌症儿科癌症，也是最难治疗的癌症之一。DANYELZA被公认为患者的关键治疗选择，并扩大了门诊环境中提供者的治疗途径。我相信，通过与Y-mAbs团队的合作，我们可以继续为该产品生成数据，将合作伙伴关系扩大到更多的肿瘤中心，并对更多神经母细胞癌患者及其家人的生活产生积极影响。” SERB主席Jeremie Urbain表示：“继SERB五年前进军美国市场后，此次收购反映了我们建立全球领先的专业制药平台的增长战略的又一个里程碑。DANYELZA是SERB的绝佳战略选择，因为它加强了我们现有的罕见肿瘤产品组合，并将使我们能够利用我们现有的全球足迹以及我们的医疗、监管和商业专业知识，将DANYELZA的业务范围扩展到新市场。” SERB拥有越来越多的罕见急诊药物、罕见疾病和CBRN准备药物组合，为世界各地的医疗保健提供者提供服务。收购DANYELZA扩大了SERB现有的罕见肿瘤学产品组合（Vorazaze®、Vistogard®、Xermelo®），并进一步推进了其建立领先的药物组合以提高全球患者护理标准的使命。 Y-mAbs总裁、首席执行官兼董事会成员Michael Rossi表示：“我们的董事会定期审查我们的业务，包括我们的战略、生物制药行业的现状以及执行我们的战略计划所需的时间和资源。在探索公司所有潜在前进道路的全面过程之后，我们现在正在推进与SERB的这项协议，我们认为这反映了Y-mAbs最具吸引力的选择，为我们的股东提供了重大、即时和确定的价值。” 关注下方公众号，带你看世界!

Specialty drugmaker SERB Pharmaceuticals plans to buy cancer biotech Y-mAbs Therapeutics to further broaden its portfolio of more than 70 medicines. SERB will pay $8.60 per share to buy Y-mAbs $YMAB , the companies said Tuesday morning. Y-mAbs’ stock price skyrocketed 103% to $8.51 apiece, nearly matching the buyout price, in afternoon trading. The all-cash deal places a $412 million equity value on the New Jersey and Danish biotech, which markets a neuroblastoma treatment called Danyelza, a GD2 antibody that was approved in November 2020. In May, the biotech guided to full-year 2025 revenues of $75 million to $90 million. Over the years, Y-mAbs had faced multiple setbacks, including the FDA’s rejection of its other neuroblastoma drug called omburtamab . It resorted to multiple rounds of layoffs. The company was founded in 2015 by Thomas Gad , whose daughter was diagnosed with high-risk neuroblastoma at a young age. The startup went public via a $96 million IPO in September 2018. More recently, Y-mAbs had also been building out an early-stage pipeline in the hot radiopharmaceuticals space to pad its longer-term future. SERB CEO Vanessa Wolfeler told Endpoints News that the company will work with Y-mAbs and others to “find the best path for this platform.” In the deal announcement, Y-mAbs said its sale process involved talks with “numerous potential buyers” for the company, for Danyelza on its own, and for the radiopharmaceutical unit as a standalone. The board also looked at “potential sources of additional capital” to keep its pipeline R&D humming. SERB’s Y-mAbs deal could be further augmented by additional acquisitions, Wolfeler said. Business development has been a core strategy for the pharmaceutical company over the years, including last year’s deal to land a frostbite treatment from CiVi Biopharma. One of its biggest deals to date was the $800 million cash purchase of BTG Specialty Pharmaceuticals. That deal, which closed in 2021, included three drugs that were expected to garner a total of $210 million in revenue in 2020. SERB plans to continue growing across more disease areas and patient populations, said Wolfeler, who joined last year after leading Sanofi’s US Dupixent business and rare disease franchise. Growth could come via label expansion and new indications for existing treatments and acquisitions. That growth could also come via geographic expansion. The company directly sells medicines in 18 countries and supplies treatments in more than 100 countries, according to its website. “We have a lot of products that are not necessarily launched across all geographies, and we have a global platform that we can leverage to continue to expand into new geographies,” Wolfeler said. SERB is currently about a $400 million-per-year revenue company, Wolfeler said. The goal is to grow to $1 billion per year in revenues, she added. The company has more than 500 employees, with about one-third each in the US, UK and rest of Europe, the CEO said. It is backed by private equity firms Charterhouse Capital Partners, Partners Group and Mérieux Equity Partners, among others.