Delocamten

— ——Edgewise to Receive $1.55 Billion in Upfront Cash Consideration and is Eligible to Receive up to $1.1 Billion in Regulatory and Commercial Milestones Edgewise将获15.5亿美元前期现金对价，并有资格获得最高11亿美元的监管与商业化里程碑付款。— ——— Transaction Creates Focused Cardiovascular Company with Enhanced Strategic Clarity —— 本次交易打造了一家战略定位更加清晰的专注型心血管企业— ——— Upfront Proceeds Expected to Fully Fund EDG-7500 Development Through Potential Approval — 预期首付款将全额支持EDG-7500的研发，直至潜在获批— ——— On Track to Report 12-Week CIRRUS-HCM Part D Data in Q2 2026 — — 预计将于2026年第二季度公布CIRRUS-HCM试验D部分12周数据 —BOULDER, Colo. 博尔德，科罗拉多州, ，June 1, 2026 2026年6月1日/PRNewswire/ --Edgewise Therapeutics, Inc. (Nasdaq: /美通社/——Edgewise Therapeutics公司（纳斯达克：EWTX EWTX), a leading muscle disease biopharmaceutical company, today announced that it has entered into a definitive agreement under which Servier, an independent international pharmaceutical group governed by a foundation, will acquire sevasemten and Edgewise's muscular dystrophy business for $1.55 billion in upfront cash consideration and up to $1.1 billion in additional milestone payments, for aggregate potential consideration of up to $2.65 billion. The transaction meaningfully strengthens Edgewise's balance sheet, providing enhanced financial flexibility and sharpening the Company's strategic focus to accelerate and unlock the full potential of its cardiovascular pipeline. ），一家领先的肌肉疾病生物制药公司今日宣布已达成最终协议。根据该协议，由基金会管理的独立国际制药集团施维雅（Servier）将以15.5亿美元的前期现金对价及最高11亿美元的额外里程碑付款，收购sevasemten及Edgewise的肌营养不良业务，潜在总对价最高可达26.5亿美元。该交易将显著增强Edgewise的资产负债表实力，提升财务灵活性，并使公司战略重心更加聚焦，从而加速推进并充分释放其心血管产品管线的全部潜力。Following the closing of the transaction, Edgewise will become a cardiovascular focused company, with a pipeline comprising EDG-7500 for hypertrophic cardiomyopathy, EDG-15400 for HFpEF and EDG-003 for an undisclosed target.. 交易完成后，Edgewise将成为一家专注于心血管领域的公司，其研发管线包括用于治疗肥厚型心肌病的EDG-7500、用于治疗HFpEF的EDG-15400，以及针对未公开靶点的EDG-003。Under the terms of the agreement, Servier will acquire all rights to sevasemten, including related intellectual property, know-how, key agreements, regulatory filings, and clinical data required to operate the muscular dystrophy business. All Edgewise employees who primarily support the muscular dystrophy business will receive a comparable offer at Servier to ensure continuity of development and future commercial execution. 根据协议条款，施维雅将获得 sevasemten 的全部权利，包括运营肌营养不良症业务所需的知识产权、专有技术、关键协议、监管申报资料及临床数据。所有主要支持肌营养不良症业务的 Edgewise 员工都将获得施维雅提供的条件相当的聘用要约，以确保研发的连续性及未来商业化的顺利推进。The transaction reflects Edgewise's strategic focus on advancing its cardiovascular portfolio, while positioning sevasemten with an acquirer who brings the global development, regulatory, and commercial capabilities required to fully realize sevasemten's potential for patients.. 此次交易反映了Edgewise专注于推进其心血管管线的战略重点，同时为sevasemten引入了具备全球研发、监管及商业化能力的收购方，以充分实现该药物惠及患者的潜力。'Servier's focus on precision therapeutics and its dedication to rare neurological and neuromuscular diseases make them the ideal steward for the program,' said Kevin Koch, Ph.D., President and Chief Executive Officer of Edgewise Therapeutics. 'This transaction delivers immediate, significant value — including $1.55 billion upfront — while placing sevasemten with an acquirer that has the global scale, patient commitment, and commercial reach to maximize its potential for individuals living with Becker and Duchenne muscular dystrophy. “施维雅专注于精准治疗，且致力于罕见神经与神经肌肉疾病领域，这使其成为该项目的理想负责方，”Edgewise Therapeutics总裁兼首席执行官凯文·科赫博士表示，“此次交易将带来即时且显著的价值——包括15.5亿美元首付款——同时将sevasemten交由一家具备全球规模、深切致力于患者并拥有强大商业化网络的收购方，从而最大化该药物为贝克型肌营养不良症和杜氏肌营养不良症患者带来的潜力。”Equally important, this transaction strengthens our balance sheet and provides financial flexibility to advance EDG-7500 and EDG-15400 through key value-inflection points.'. 同样重要的是，此次交易增强了我们的资产负债表，并为推进 EDG-7500 和 EDG-15400 跨越关键价值拐点提供了财务灵活性。'Edgewise is a pioneer in muscle disease biology with a proven track record of discovering and developing precision therapies for patients with serious neurological conditions,' said Olivier Laureau, President of Servier. 'The acquisition of sevasemten and Edgewise's muscular dystrophy business, including highly experienced talent across research, development, regulatory, and commercial functions, provides an immediate platform to expand our portfolio into Becker and Duchenne muscular dystrophy. 施维雅总裁奥利维耶·拉罗表示：“Edgewise是肌肉疾病生物学领域的先驱，在为患者发现和开发治疗严重神经系统疾病的精准疗法方面拥有经过验证的成功记录。收购sevasemten及Edgewise的肌营养不良症业务，连同在研发、监管和商业化职能方面经验丰富的人才，为我们提供了一个现成平台，使我们能够迅速将产品管线拓展至贝克尔型与杜氏肌营养不良症领域。”In line with our 2030 ambition, this positions us as a major player in neuromuscular indications to serve more patients living with devastating rare diseases.'. 秉承我们2030年的战略目标，此举将确立我们在神经肌肉适应症领域的重要地位，从而惠及更多饱受严重罕见病折磨的患者。Advancing the Cardiovascular Pipeline 推进心血管研发管线Separately, the Company reaffirmed that it plans to report 12-week data from Part D of the CIRRUS-HCM Phase 2 trial of EDG-7500 in the second quarter of 2026. The 12-week Part D data, which will include safety, echocardiographic, biomarker, and patient-reported outcome assessments across both oHCM and nHCM, are expected to inform the Phase 3 design, with initiation targeted for the fourth quarter of 2026. In parallel, Edgewise remains on track to initiate a Phase 2 trial of EDG-15400 in heart failure with preserved ejection fraction (HFpEF), further advancing the Company's cardiovascular pipeline. 此外，公司重申，计划于2026年第二季度公布EDG-7500在CIRRUS-HCM 2期临床试验D部分的12周数据。该D部分12周数据将涵盖梗阻性肥厚型心肌病（oHCM）和非梗阻性肥厚型心肌病（nHCM）的安全性、超声心动图、生物标志物及患者报告结局评估，预计将为3期临床试验的设计提供依据，启动目标定于2026年第四季度。与此同时，Edgewise正按计划推进EDG-15400在射血分数保留的心力衰竭（HFpEF）领域的2期临床试验，将进一步推进公司的在研心血管管线。Additionally, the Company believes the upfront proceeds from this transaction, combined with its existing cash position, will fully fund EDG-7500 development through potential approval and provide the financial strength to further build and expand its cardiovascular pipeline.. 此外，公司认为，此次交易的首付款结合其现有现金储备，将全额资助EDG-7500的研发直至潜在获批，并为其进一步构建和拓展心血管管线提供充足的资金实力。Advisors 顾问Centerview Partners LLC is acting as exclusive financial advisorto Edgewise with Wilson Sonsini Goodrich & Rosati serving as legal counsel. Centerview Partners LLC 担任 Edgewise 的独家财务顾问，Wilson Sonsini Goodrich & Rosati 担任法律顾问。The transaction is subject to customary closing conditions, including expiration of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976. The transaction has been unanimously approved by the boards of directors of both Edgewise Therapeutics and Servier. Subject to the satisfaction or waiver of customary closing conditions, Servier and Edgewise expect the transaction to close in the third quarter of 2026.. 该交易须满足惯例交割条件，包括《1976年哈特-斯科特-罗迪诺反垄断改进法》项下的等待期届满。该交易已获Edgewise Therapeutics与Servier双方董事会一致批准。在满足或豁免惯例交割条件的前提下，Servier与Edgewise预计该交易将于2026年第三季度完成交割。About Sevasemten 关于 SevasemtenSevasemten presents a novel mechanism of action designed to selectively limit the exaggerated muscle damage caused by the absence or loss of functional dystrophin. Sevasemten is being studied in late-stage clinical trials in Becker and Duchenne muscular dystrophy. If approved, sevasemten would be the first therapy indicated for Becker muscular dystrophy, a rare, genetic, X-linked neuromuscular disorder that predominantly affects males and for which approximately 12,000 individuals are affected in the U.S., EU-5, and Japan.. Sevasemten具有全新的作用机制，旨在选择性地减轻因功能性肌营养不良蛋白缺失或丧失而导致的过度肌肉损伤。目前，Sevasemten正在针对贝克型肌营养不良症和杜氏肌营养不良症开展后期临床试验。若获批上市，Sevasemten将成为首个用于治疗贝克型肌营养不良症的疗法。该病是一种罕见的遗传性X连锁神经肌肉疾病，主要影响男性，在美国、欧盟五国及日本约有1.2万名患者。Sevasemten has demonstrated sustained disease stabilization in clinical studies spanning more than three years of treatment. In the MESA open-label extension study, participants maintained stable North Star Ambulatory Assessment (NSAA) scores in marked contrast to the functional decline expected from Becker natural history data. Sevasemten在涵盖超过三年治疗的临床研究中已证实可实现持续的病情稳定。在MESA开放标签扩展研究中，受试者的北星步行评估（NSAA）评分保持稳定，这与根据贝克型肌营养不良自然病史数据预期的功能衰退形成了鲜明对比。Sevasemten has maintained a favorable safety and tolerability profile, with no discontinuations or dose reductions due to adverse events.. Sevasemten的安全性和耐受性良好，未发生因不良事件导致的停药或剂量减少。Sevasemten has achieved notable regulatory milestones by securing FDA Orphan Drug Designation for the treatment of Becker and Duchenne, Rare Pediatric Disease Designation (RPDD) for the treatment of Duchenne, and Fast Track designations for the treatment of Becker and Duchenne. Further, sevasemten secured the EMA Orphan Drug Designations for the treatment of Becker and Duchenne.. Sevasemten已取得重要的监管里程碑，获得了FDA针对贝克型与杜氏型肌营养不良症治疗的孤儿药资格认定、针对杜氏型肌营养不良症治疗的罕见儿科疾病资格认定（RPDD），以及针对贝克型与杜氏型肌营养不良症治疗的快速通道资格认定。此外，Sevasemten还获得了EMA针对贝克型与杜氏型肌营养不良症治疗的孤儿药资格认定。The GRAND CANYON pivotal cohort in Becker is fully enrolled with 175 participants and powered at greater than 98% to deliver a statistically significant difference versus placebo, with top-line data expected in the fourth quarter of 2026. GRAND CANYON研究中Becker关键队列的175名受试者已全部入组，该队列统计功效超过98%，足以得出与安慰剂相比具有统计学显著差异的结果，顶线数据预计将于2026年第四季度公布。About Edgewise Therapeutics 关于 Edgewise TherapeuticsEdgewise Therapeutics is a leading muscle disease biopharmaceutical company developing novel therapeutics for muscular dystrophies and serious cardiac conditions. The Company's deep expertise in muscle physiology is driving a new generation of novel therapeutics. Sevasemten is an orally administered first-in-class fast skeletal myosin inhibitor in late-stage clinical trials in Becker and Duchenne muscular dystrophies. 埃奇威斯治疗公司（Edgewise Therapeutics）是一家领先的肌肉疾病生物制药企业，致力于研发用于治疗肌营养不良症和严重心脏疾病的新型治疗药物。公司在肌肉生理学领域的深厚专长正推动着新一代创新疗法的研发。塞瓦塞腾（Sevasemten）是一种口服的同类首创快速骨骼肌肌球蛋白抑制剂，目前正针对贝克型肌营养不良症和杜氏肌营养不良症开展后期临床试验。EDG-7500 is a novel cardiac sarcomere modulator for the treatment of symptomatic hypertrophic cardiomyopathy, currently in Phase 2 clinical development. EDG-15400 is a novel cardiac sarcomere modulator for the treatment of heart failure, currently in Phase 1 clinical development. The entire team at Edgewise is dedicated to our mission: changing the lives of patients and families affected by serious muscle diseases. EDG-7500是一种用于治疗症状性肥厚型心肌病的新型心肌肌节调节剂，目前正处于II期临床开发阶段。EDG-15400是一种用于治疗心力衰竭的新型心肌肌节调节剂，目前正处于I期临床开发阶段。Edgewise团队全体成员致力于我们的使命：改变受严重肌肉疾病影响的患者及其家庭的生活。To learn more, go to edgewisetx.com or follow us on LinkedIn, X, Facebook and Instagram.. 如需了解更多信息，请访问 edgewisetx.com，或在 LinkedIn、X、Facebook 和 Instagram 上关注我们。Forward-Looking Statements 前瞻性陈述This press release contains forward-looking statements as that term is defined in Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Statements in this press release that are not purely historical are forward-looking statements. Such forward-looking statements include, among other things, statements regarding the sale of sevasemten and Edgewise's muscular dystrophy business to Servier (Transaction), including the Transaction timeline and potential payments which may become owing to Edgewise; the impact and effects of the Transaction on Edgewise's business and financial position; Edgewise's cash runway and use of proceeds from the Transaction; the potential of, and expectations regarding, Edgewise's product candidates and programs, including sevasemten, EDG-7500, EDG-15400 and its cardiovascular programs; statements regarding Edgewise's expectations relating to its clinical trials, including timing of data (including 12-week data on the CIRRUS-HCM trial and data from the GRAND CANYON trial); statements regarding sevasemten potentially being the first approved therapy for Becker; statements regarding timing of Edgewise's initiation of a Phase 3 trial of EDG-7500 in HCM and a Phase 2 trial of EDG-15400 in HFpEF; statements regarding Edgewise's ability to advance its pipeline; and statements by Edgewise's President and Chief Executive Officer and Servier's President. Words such as 'believes,' 'anticipates,' 'plans,' 'expects,' 'intends,' 'will,' 'goal,' 'targets,' 'potential' and similar expressions are intended to identify forward-looking statements. The forward-looking statements contained herein are based upon Edgewise's current expectations and involve assumptions that may never materialize or may prove to be incorrect.. 本新闻稿包含《1933年证券法》第27A条和《1934年证券交易法》第21E条所界定的前瞻性陈述。本新闻稿中非纯粹基于历史事实的陈述均属前瞻性陈述。此类前瞻性陈述包括但不限于：关于向Servier出售sevasemten及Edgewise肌营养不良症业务（“本次交易”）的陈述，涵盖本次交易的时间表及可能应付予Edgewise的款项；本次交易对Edgewise业务与财务状况的影响及效应；Edgewise的资金续航期及本次交易所得款项的用途；关于Edgewise候选产品及研发项目（包括sevasemten、EDG-7500、EDG-15400及其心血管项目）的潜力与相关预期；关于Edgewise临床试验预期的陈述，包括数据发布时间（含CIRRUS-HCM试验的12周数据及GRAND CANYON试验的数据）；关于sevasemten可能成为首个获批治疗贝克型肌营养不良症（Becker）药物的陈述；关于Edgewise启动EDG-7500治疗肥厚型心肌病（HCM）的III期临床试验及EDG-15400治疗射血分数保留的心力衰竭（HFpEF）的II期临床试验时间安排的陈述；关于Edgewise推进其研发管线能力的陈述；以及Edgewise总裁兼首席执行官与Servier总裁的相关发言。“相信”、“预期”、“计划”、“预计”、“打算”、“将”、“目标”、“指标”、“潜在”及类似表述旨在识别前瞻性陈述。本文所载前瞻性陈述基于Edgewise当前的预期，并涉及可能永远无法实现或被证明不正确的假设。SOURCE Edgewise Therapeutics 来源：埃奇韦斯治疗公司21 二十一% 百分号more press release views with 借助……获得更多新闻稿浏览量Request a Demo 申请演示

Merck 应该是MNC中 最有钱的并购或者BD合作方之一，26年预算150亿美元及以上，会更加关注偏后期的资产，甚至商业化的资产，同样会关注后期临床资产的包括  JNJ则更加关注早期资产，选择做小deal，但每个BD都做的很稳健，有POC data 才会出手。 作为下一个心血管健康管理的重磅靶点Lpa 已经很卷了，集齐了Amgen，AZ，Novartis，Merck等； Cardiovascular-pulmonary-Renal 是MNC 关注的下一个重点，已经有几家MNC 开启早期布局了;自免是所有MNC的关注重点 BC领域的布局开始打明牌了，一线的药物开始迭代了，26-27年会有大的BD机会 肥胖领域的自费市场比大家想的大，辉瑞将其类比成了伟哥 Lilly 对于AD preclinical 的Phase3 很有信心，27年读数（也可能是瞎吹） 核药的机会会进一步扩大，个人觉得很适合中国，极有可能是下一个浪潮 MNC作为最大的买家，还是会积极的抢好的资产 AMGEN 前三季度10%的销售额增长，其中14款药物销售额超过10亿美元。其中CV，骨科，和呼吸疾病销售额增长迅速。 Repatha(evocumab): PCSK9抗体，销售额增长33%，前三季度销售额预计30亿美元 EVENITY(Romosozumab): 销售额增长33%，前三季度销售额预计20亿美元 TEZSPIRE（Tezepelumab）: 销售额额增长49%，前三季度销售额预计10亿美元 BiTE 平台产生近20亿美金的销售收入，Tarlatamab 和Blinatumomab 的销售增速都挺超过30%。 Olpasiran（Lpa-SiRNA）应该是Amgen 的下一个重磅，但依然要等待Lpa 的降低对CV Event 的影响。 从BD的角度上：新型的双功能小分子应该是Amgen 关注的重点之一。 在投资人问答上，券商对Amgen 的减肥药兴趣很大，公司回应得比较保守。 BMS Eliquis（通用名：阿哌沙班）目前依然贡献了BMS最大的单品收入，但由于专利即将到期，BMS瞄准了下一个单品小分子FXIa i（Milvexian），在26年读出phase 3临床结果。 Reblozyl全年销售额超过20亿美元，后续还有一个MYK-224 HFpEF (AURORA) 的早期临床资产。 在25年管线数量增长了17%，大部分是早期管线。去年BD了5个资产，26年会继续加强BD，尤其会更加的关注临床Phase 2及以后阶段的资产。BD领域：会关注BMS目前布局的疾病领域，加强管线深度。 目前Phase 3 CV资产比较单薄，所以CV会是BMS BD的重点吗？ JNJ 每年稳定增长的MNC，在药物领域，目前只集中在oncology, immunology and neuroscience 这三个领域，但给自己定了一个巨大的目标：but we have set our goal for oncology to be a $50 billion business for Johnson & Johnson by 2030, being the #1 oncology company. 在自免领域，拥有IL-23 抗体（75%的销售来自于IBD）和口服IL-23R 多肽，这两个都是自免的重磅。在CNS领域，JNJ的布局更多的是在精神类领域，schizophrenia, Bipolar, major depressive disorder等，都是具有不错的市场。额外的是，宣称未来所有的药物都会在美国生产。 关于BD： JNJ的BD重点还是会侧重在早期资产以及小Deal，之前BD进来的资产，也都是在临床早期开始建立合作BD，同时也非常注重Derisk，有一定的POC才会下手。 Merck： 快乐并痛苦中，快乐的是目前K药销售额很好，现金充足，痛苦的是要面临K药销售额的下滑，因此Merck 这几年的动作之一是通过药物联用的策略增加或者尽量保持K药的销售额，二是寻找其他板块的销售额增长点。 从verona pharma 收购的COPD产品OHTUVAYRE 销售放量很快，和PAH的药物是重要的近期增长点之一。 他的潜在增长点包括口服PCSK9 抑制剂，Trop2 ADC ，口服DME药物，TL1A -IBD等，Trop2 ADC 目前已经开了16个Phase 3临床，在探索很多新的适应症；口服PSCK9期待和Lpa小分子（恒瑞）Combo，挑战目前的CV一级预防SOC。  布局的重点还是肿瘤，心脏代谢和心肺领域。尽管目前心肺领域资产比较单一 BD的角度： 26年可以进行150亿美元以上的BD，但会更加关注后期资产特别是Derisk资产，就买贵的。同时也是目前和中国合作比较多的MNC之一。 AZ AZ的布局重点包括CV，ADC，细胞疗法等，baxdrostat（高血压药物）和laroprovstat（PCSK9i） 都是CV领域的潜在重磅药物，与减肥药也有一定的协同。ADC 则手握重磅药物8201，AZ算是目前把细胞治疗作为发展重点之一的MNC药企。与Merck 的财大气粗不同，AZ在26年的总体研发预算有限，不会超过100亿美金的研发预算，还要做104个phase 3， 留给BD的钱就不多了，应该也只能做做小deal. 关于减肥，会计划做差异化布局，因此不排除AZ在减肥领域也会合作一些管线。 AZ在NSCLC，BC和GI都有很强的tumor，因此也不排除在这三个领域会进行一些新的协同布局 Lilly: Lilly的网上药店卖的很好，已经超过100万人购买了，在和辉瑞/诺和的隔空回应很有意思 目前有充足的研发费用/资金来补充管线，看语气更多的是布局早期资产，中间提到核药是重点之一。对Prevention AD 的信心很足，27年会读出数据。 Novartis Novartis 目前最强的是CV和肌肉神经疾病，尤其是在25年的几起并购，把神经肌肉领域的护城河完全建立起来了，肿瘤排在靠后的地位，目前双抗和ADC布局的比较少，后续会加强这两个领域的布局，美国，德国，中国是诺华的前三销售额来源。 对CSU的市场还挺乐观的 BD的动作更多的是聚焦CV-pulmonary disease-renal，神经肌肉疾病（这个领域的王者了），免疫，和部分肿瘤。 上调了Pluvicto的销售目标，预计超过50亿美元的市场，目前在美国已经有超过700个中心可以使用核药，后续核药的临床进度会更快，布局了22个临床前的核药项目，也布局了多种核素。 关于BD： 势在必行要买Oral SERD了，26年会继续买资产，账上还有200亿美金的现金，大爷有钱。特别是愿意花钱在内部有深度理解的领域。 Pfizer： 计划把GLP-1领域的药物当成消费品来卖，类比伟哥。强调了自己的销售能力，26年会有60亿美元的BD预算 Roche 肿瘤，神经，代谢是目前Roche布局的重点，在BD层面更加偏重中早期的项目，希望和现有管线可以形成很好的战略协同。 Sanofi: 炎症和免疫最大的MNC玩家，Dupi 占了销售额增长的1/3，25年BD的钱没有花完，26年会增加Phase 1的项目，但同时也会引进后期的项目。