— Edgewise receives

— Edgewise 接收

$1.55 billion in upfront cash and is eligible to receive up to $1.1 billion in regulatory and commercial milestones —

15.5亿美元的预付款现金，并有资格获得高达11亿美元的监管和商业里程碑付款——

— Transaction creates strategically focused cardiovascular company —

— 交易打造战略聚焦的心血管疾病公司 —

— Upfront proceeds expected to fully fund EDG-7500 development through potential approval —

— 预计前期收益将足以全额资助EDG-7500的研发，直至可能获得批准 —

BOULDER, Colo.

科罗拉多州博尔德

,

，

July 13, 2026

2026年7月13日

/PRNewswire/ -- Edgewise Therapeutics, Inc. (Nasdaq:

/美通社/ -- Edgewise Therapeutics, Inc.（纳斯达克：

EWTX

EWTX

), a leading clinical-stage biopharmaceutical company focused on cardiovascular diseases, today announced the successful completion of its previously announced definitive agreement under which Servier, an independent international pharmaceutical group governed by a foundation, acquired 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.

），一家专注于心血管疾病的领先临床阶段生物制药公司，今日宣布其此前宣布的最终协议已顺利完成。根据该协议，由基金会管理的独立国际制药集团施维雅（Servier）以15.5亿美元的预付现金对价以及高达11亿美元的额外里程碑付款，收购了sevasemten和Edgewise的肌营养不良症业务，潜在总对价高达26.5亿美元。

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. This transaction marks Edgewise's transition to a cardiovascular-focused company, with a pipeline comprising EDG-7500 for hypertrophic cardiomyopathy, EDG-15400 for HFpEF and EDG-003 for an undisclosed target..

该交易显著增强了 Edgewise 的资产负债表，提升了财务灵活性，并使公司战略焦点更加明确，以加速释放其心血管产品管线的全部潜力。此次交易标志着 Edgewise 向专注于心血管领域的公司转型，其产品线包括用于肥厚型心肌病的 EDG-7500、用于射血分数保留的心力衰竭（HFpEF）的 EDG-15400，以及针对未公开靶点的 EDG-003。

Under the terms of the agreement, Servier acquired all rights to sevasemten, including related intellectual property, know-how, key agreements, regulatory filings, and clinical data required to operate the muscular dystrophy business. The core Edgewise employee group primarily supporting the muscular dystrophy business received offers to transition to Servier to ensure continuity of development and future commercial execution.

根据协议条款，Servier 获得了 sevasemten 的所有权利，包括相关的知识产权、专有技术、关键协议、监管文件以及运营肌肉萎缩症业务所需的临床数据。主要支持肌肉萎缩症业务的 Edgewise 核心员工团队收到了加入 Servier 的邀请，以确保研发工作的连续性以及未来商业执行的顺利进行。

The transaction reflects Edgewise's strategic focus on advancing its cardiovascular portfolio, while positioning sevasemten with Servier, which brings the global development, regulatory, and commercial capabilities required to fully realize sevasemten's potential for patients..

此次交易体现了Edgewise专注于推进其心血管产品组合的战略重点，同时通过与Servier合作推广sevasemten，借助后者具备的全球开发、监管和商业能力，充分实现sevasemten为患者带来的潜力。

'Completing this transaction with Servier marks an important milestone for Edgewise and for the sevasemten program,' said Kevin Koch, Ph.D., President and Chief Executive Officer of Edgewise Therapeutics. 'I want to thank the many colleagues whose dedication and expertise have advanced sevasemten to this point; this progress would not have been possible without their contributions.

“与施维雅完成此次交易，标志着Edgewise公司以及sevasemten项目的一个重要里程碑。” Edgewise Therapeutics 的总裁兼首席执行官 Kevin Koch 博士表示。“我要感谢众多同事，他们的敬业精神和专业知识推动了 sevasemten 发展到当前阶段；没有他们的贡献，这一进展将不可能实现。

We're confident Servier's global scale, deep expertise in rare diseases, and commitment to patients will help fully realize sevasemten's potential for individuals living with Becker and Duchenne muscular dystrophy. This transaction also strengthens our balance sheet and provides the financial flexibility to advance EDG-7500 and EDG-15400 through key value-inflection points.'.

我们坚信，施维雅的全球规模、在罕见病领域的深厚专业知识以及对患者的承诺，将有助于充分实现sevasemten为贝克氏肌营养不良和杜氏肌营养不良患者带来的潜力。此次交易也强化了我们的资产负债表，并为推进EDG-7500和EDG-15400度过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 neuromuscular conditions,' said Olivier Laureau, President of Servier. 'With the successful closing of this acquisition, we are pleased to welcome a highly experienced team and a strong ambition in Becker and Duchenne muscular dystrophy to Servier.

“Edgewise 是肌肉疾病生物学领域的先驱，在发现和开发针对严重神经肌肉疾病患者的精准疗法方面拥有经证实的卓越记录。”施维雅总裁奥利维耶·拉罗表示，“随着此次收购顺利完成，我们很高兴欢迎一支经验丰富的团队加入施维雅，并期待其在贝克型肌营养不良和杜氏肌营养不良领域展现出的远大抱负。”

This is a strategic milestone in achieving Servier 2030 to become a new player in rare neurology and to serve patients living with devastating rare diseases.'.

“这是实现‘Servier 2030’战略目标的重要里程碑，旨在成为罕见神经疾病领域的新兴力量，并为遭受毁灭性罕见疾病困扰的患者提供服务。”

Advancing the Cardiovascular Pipeline

推进心血管产品管线

Separately, based on recent positive 12-week data from Part D of the CIRRUS-HCM Phase 2 trial of EDG-7500, which included safety, echocardiographic, biomarker, and patient-reported outcome assessments across both oHCM and nHCM, the Company is expecting to initiate a Phase 3 trial in the fourth quarter of 2026.

此外，基于EDG-7500在CIRRUS-HCM二期试验D部分中最近的阳性12周数据（该部分包括对梗阻性肥厚型心肌病[oHCM]和非梗阻性肥厚型心肌病[nHCM]患者的安全性、超声心动图、生物标志物及患者报告结局的评估），公司预计将于2026年第四季度启动三期临床试验。

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. 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..

与此同时，Edgewise 公司按计划推进 EDG-15400 在射血分数保留型心力衰竭（HFpEF）患者中的 II 期临床试验，进一步推动其心血管产品管线的进展。此外，公司认为，本次交易的前期收益结合其现有现金储备，将足以全额资助 EDG-7500 的研发直至潜在获批，并为其进一步建设和扩展心血管产品管线提供坚实的财务支持。

Advisors

顾问

Centerview Partners LLC acted as exclusive financial advisor to 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。

About Sevasemten

关于 Sevasemten

Sevasemten 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 提出了一种新颖的作用机制，旨在选择性地限制因功能性抗肌萎缩蛋白缺失或丧失而导致的过度肌肉损伤。Sevasemten 正在贝克氏肌营养不良和杜氏肌营养不良的后期临床试验中进行研究。如果获得批准，Sevasemten 将成为首个适用于贝克氏肌营养不良的疗法。贝克氏肌营养不良是一种罕见的、遗传性的、X连锁的神经肌肉疾病，主要影响男性，在美国、欧盟五国和日本约有12,000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在历时三年以上的临床研究中展现出持续的疾病稳定效果。在MESA开放标签扩展研究中，受试者的北星 ambulancy 评估（NSAA）评分保持稳定，与贝克肌营养不良自然病史数据所预期的功能衰退形成鲜明对比。

Sevasemten has maintained a favorable safety and tolerability profile, with no discontinuations or dose reductions due to adverse events..

Sevasemten 保持了良好的安全性和耐受性特征，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 EMA Orphan Drug Designations for the treatment of Becker and Duchenne..

Sevasemten 在监管方面取得了显著进展，获得了美国食品药品监督管理局（FDA）授予的用于治疗贝克型肌营养不良和杜氏肌营养不良的孤儿药资格认定、用于治疗杜氏肌营养不良的罕见儿科疾病资格认定（RPDD），以及用于治疗贝克型肌营养不良和杜氏肌营养不良的快速通道资格认定。此外，Sevasemten 还获得了欧洲药品管理局（EMA）授予的用于治疗贝克型肌营养不良和杜氏肌营养不良的孤儿药资格认定。

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.

Becker 的 GRAND CANYON 关键队列已完全入组，共纳入 175 名参与者，并且具有超过 98% 的把握度来产生与安慰剂相比具有统计学意义的差异。预计将在 2026 年第四季度公布主要数据。

About Edgewise Therapeutics

关于 Edgewise Therapeutics

Edgewise Therapeutics is a leading biopharmaceutical company focused on novel, muscle-targeted therapeutics. Leveraging its expertise in muscle biology and small molecule drug development, Edgewise is advancing a cardiovascular pipeline targeting significant unmet needs, including hypertrophic cardiomyopathy, heart failure and other serious cardiovascular and cardiometabolic conditions.

Edgewise Therapeutics 是一家领先的生物制药公司，专注于新型肌肉靶向疗法。凭借在肌肉生物学和小分子药物开发方面的专业知识，Edgewise 正在推进其心血管产品管线的研发，以满足包括肥厚型心肌病、心力衰竭以及其他严重心血管和心脏代谢疾病在内的重大未满足医疗需求。

To learn more, go to edgewisetx.com or follow us on LinkedIn, X, Facebook and Instagram..

欲了解更多信息，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  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 sevasemten and Edgewise's product candidates and programs, including EDG-7500, EDG-15400 and EDG-003; statements regarding Edgewise's expectations relating to its clinical trials, including the timing of top-line data for the GRAND CANYON pivotal cohort in Becker; the timing of initiation of a Phase 3 trial of EDG-7500 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.

本新闻稿包含经1933年《证券法》第27A条和1934年《证券交易法》第21E条界定的前瞻性陈述。本新闻稿中非纯粹历史性的陈述均为前瞻性陈述。此类前瞻性陈述包括但不限于：关于将sevasemten及Edgewise的肌营养不良症业务出售给Servier（以下简称“本次交易”）的陈述，包括可能应付给Edgewise的潜在款项；本次交易对Edgewise业务及财务状况的影响和效应；Edgewise的现金跑道及对本次交易所得款项的使用；sevasemten以及Edgewise的产品候选物和项目（包括EDG-7500、EDG-15400和EDG-003）的潜力及相关预期；关于Edgewise对其临床试验预期的陈述，包括Becker型肌营养不良症关键队列GRAND CANYON的顶线数据发布时间；启动EDG-7500的III期临床试验以及在射血分数保留的心力衰竭（HFpEF）中启动EDG-15400的II期临床试验的时间安排；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总裁的声明。

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.

“相信”、“预期”、“计划”、“预计”、“打算”、“将”、“目标”、“指标”、“潜力”等词语及类似表述旨在识别前瞻性陈述。本文所载的前瞻性陈述基于 Edgewise 当前的预期，并涉及可能永远无法实现或可能被证明不正确的假设。

Actual results could differ materially from those projected in any forward-looking statements due to numerous risks and uncertainties, including but not limited to: risks related to milestones re.

由于存在多种风险和不确定性，实际结果可能与任何前瞻性陈述中预测的结果存在重大差异，包括但不限于：与里程碑相关的风险。

SOURCE Edgewise Therapeutics

来源：Edgewise Therapeutics

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