Edgewise Therapeutics报告2026年第一季度财务业绩并推进肌肉萎缩症和心血管适应症的临床项目-动脉网

Edgewise Therapeutics Reports First Quarter 2026 Financial Results and Advances Clinical Programs in Muscular Dystrophy and Cardiovascular Indications

PR Newswire 等信源发布 2026-05-07 19:58

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Announced positive long-term sevasemten data demonstrating sustained functional stabilization in Becker muscular dystrophy (Becker) up to 3.5 years of follow-up –

宣布了积极的长期sevasemten数据，显示在贝克尔肌营养不良症（Becker）中长达3.5年的随访中持续的功能稳定——

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CIRRUS-HCM 12-week data of EDG-7500 in obstructive and nonobstructive hypertrophic cardiomyopathy (HCM) expected in Q2 2026 –

CIRRUS-HCM 12周数据：EDG-7500用于梗阻性和非梗阻性肥厚型心肌病（HCM），预计将于2026年第二季度发布。

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Pivotal GRAND CANYON results for sevasemten in Becker expected in Q4 2026

2026年第四季度预计将迎来贝克尔Sevasemten的关键GRAND CANYON结果

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BOULDER, Colo.

科罗拉多州博尔德

，

May 7, 2026

2026年5月7日

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

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

EWTX

), a leading muscle disease biopharmaceutical company, today reported financial results for the first quarter of 2026 and recent business highlights

），一家领先的肌肉疾病生物制药公司，今天报告了2026年第一季度的财务结果和最近的业务亮点。

。

'For the first time with an investigational agent, we have generated long-term data showing that people with Becker remain stable despite a disease that typically leads to significant functional decline,' said Kevin Koch, Ph.D., President and Chief Executive Officer of Edgewise. 'We remain on track to report pivotal top-line data from GRAND CANYON evaluating sevasemten, which has the potential to support our first marketing application in Becker.

“我们首次使用一种研究性药物，生成了长期数据，表明贝克尔患者尽管通常会导致显著的功能衰退，但仍然保持稳定，”Edgewise 总裁兼首席执行官 Kevin Koch 博士说道。“我们正按计划报告 GRAND CANYON 评估 sevasemten 的关键主要数据，这有可能支持我们在贝克尔症上的首个上市申请。”

We also anticipate results this quarter from CIRRUS-HCM 12-week Part D evaluating EDG-7500 in HCM, which will help refine our Phase 3 strategy. With multiple near-term catalysts and a highly focused team, we are well positioned to advance our programs and deliver potentially transformative therapeutic options for patients facing serious muscle diseases facing high unmet need.'.

我们还预计本季度将从CIRRUS-HCM的12周D部分获得评估EDG-7500在肥厚型心肌病（HCM）中的结果，这将有助于完善我们的第三阶段策略。凭借多个短期催化剂和高度专注的团队，我们有能力推进我们的项目，并为面临严重肌肉疾病且未满足需求高的患者提供可能具有变革性的治疗选择。

Recent Highlights

近期亮点

Muscular Dystrophy Program

肌肉萎缩症项目

MESA open-label extension trial in adults with Becker:

MESA 开放标签扩展试验，针对贝克尔型肌营养不良症成人患者：

MESA is an open-label extension study evaluating sevasemten long-term safety, tolerability, and efficacy in adults and adolescents with Becker previously treated in sevasemten clinical trials. Nearly all eligible participants (99%) from prior sevasemten studies (including ARCH, DUNE and CANYON/GRAND CANYON) chose to enroll in the MESA open-label extension study..

MESA 是一项开放标签扩展研究，评估塞伐森坦在先前参与塞伐森坦临床试验的贝克尔病成人和青少年中的长期安全性、耐受性和有效性。几乎所有符合条件的参与者（99%）来自之前的塞伐森坦研究（包括 ARCH、DUNE 和 CANYON/GRAND CANYON），选择加入 MESA 开放标签扩展研究。

At the 2026 MDA Clinical and Scientific Conference, the Company presented long-term data from MESA showing participants on sevasemten experienced stabilization of function up to 3.5 years in marked contrast to the functional decline expected from Becker natural history data. The data reinforce prior clinical findings of sevasemten in Becker, a rare disease with no approved treatments.

在2026年MDA临床与科学会议上，该公司展示了来自MESA的长期数据，显示接受sevasemten治疗的参与者功能稳定长达3.5年，这与贝克尔肌营养不良自然病史数据中预期的功能下降形成鲜明对比。这些数据进一步验证了sevasemten在贝克尔肌营养不良中的先前临床研究结果，这是一种尚无获批治疗方法的罕见疾病。

The results can be found .

结果可以找到。

here

这里

. The Company also presented a poster with new analysis from the CANYON study showing sevasemten had a well-tolerated cardiac profile over 12 months, with no adverse effects on left ventricular ejection fraction (LVEF) or NT‑proBNP and evidence of LVEF improvement in certain subgroups, with positive trends observed across all adult participants versus placebo.

公司还展示了一张海报，其中包含了来自CANYON研究的新分析，显示sevasemten在12个月内具有良好的心脏耐受性，对左心室射血分数（LVEF）或NT-proBNP没有不良影响，并且在某些亚组中观察到LVEF改善的证据，所有成年参与者相对于安慰剂均显示出积极趋势。

The poster can be viewed .

海报可以查看。

here

这里

. To learn more about MESA or CANYON, go to clinicaltrials.gov (MESA:

要了解更多关于MESA或CANYON的信息，请访问clinicaltrials.gov（MESA：

NCT06066580

, CANYON (

，峡谷（

NCT05291091

）。

GRAND CANYON, a global pivotal placebo-controlled cohort in Becker:

大峡谷，贝克尔全球关键的安慰剂对照队列：

GRAND CANYON is designed to assess the efficacy and safety of sevasemten over an 18-month period, with North Star Ambulatory Assessment (NSAA) as the primary endpoint. The study is highly powered to be able to show a statistically significant difference in NSAA versus placebo over 18 months. The Company expects to report top-line data in the fourth quarter of 2026 and is continuing preparations for a potential marketing application to seek approval as the first targeted therapy for this underserved population, planned for the first half of 2027.

GRAND CANYON 旨在评估 sevasemten 在 18 个月期间的疗效和安全性，其主要终点为北极星移动能力评估（NSAA）。该研究具备高度统计效力，能够在 18 个月内显示出 NSAA 相较于安慰剂的统计学显著差异。公司预计将在 2026 年第四季度公布初步数据，并继续为潜在的上市申请做准备，目标是寻求在 2027 年上半年将该药物作为首个针对这一未满足需求人群的靶向疗法获批。

To learn more about GRAND CANYON, go to clinicaltrials.gov (.

要了解更多关于大峡谷的信息，请访问clinicaltrials.gov。

NCT05291091

）。

LYNX and FOX Phase 2 placebo-controlled trials in boys with Duchenne:

LYNX 和 FOX 第二阶段安慰剂对照试验，针对患有杜氏肌营养不良症的男孩：

LYNX is designed to evaluate the effect of sevasemten on safety, biomarkers of muscle damage and function in boys with Duchenne in a placebo-controlled dose ranging study, followed by an open-label extension period. FOX is designed to evaluate the effect of sevasemten on safety, biomarkers of muscle damage and function in children and adolescents with Duchenne who have been previously treated with gene therapy.

LYNX 旨在评估sevasemten在安慰剂对照的剂量范围研究中对杜氏肌营养不良男孩的安全性、肌肉损伤和功能的生物标志物的影响，随后是一个开放标签的延长期。FOX 旨在评估sevasemten在之前接受过基因治疗的杜氏肌营养不良儿童和青少年中的安全性、肌肉损伤和功能的生物标志物的影响。

The Company continues to collect longer-term data in the open-label extension portion of these Phase 2 programs to inform the future clinical studies in Duchenne. For more information, go to clinicaltrials.gov to learn more about LYNX (.

公司继续在这些二期项目的开放标签扩展部分收集长期数据，以告知未来在杜氏肌营养不良症中的临床研究。欲了解更多信息，请访问 clinicaltrials.gov 了解更多关于 LYNX 的信息。

NCT05540860

) and FOX (

）和FOX（

NCT06100887

）。

Cardiovascular Programs

心血管项目

CIRRUS-HCM Phase 2 trial in adults with symptomatic HCM:

CIRRUS-HCM 第2阶段试验，针对有症状的成人HCM患者：

The Company is advancing CIRRUS-HCM, a multi-part, open-label trial, in participants with HCM at over 20 clinical sites in the U.S. Part A of the trial evaluated the safety and tolerability of a single oral dose of EDG-7500 in participants with obstructive HCM (oHCM). Parts B and C evaluated fixed doses of EDG-7500 over 28 days in oHCM and nonobstructive HCM (nHCM), respectively.

公司正在美国超过20个临床试验点推进CIRRUS-HCM，这是一项多部分、开放标签的试验，针对肥厚型心肌病（HCM）患者。试验的A部分评估了单次口服EDG-7500在梗阻性肥厚型心肌病（oHCM）患者中的安全性和耐受性。B部分和C部分分别评估了EDG-7500固定剂量在oHCM和非梗阻性肥厚型心肌病（nHCM）患者中持续28天的效果。

The results can be found .

结果可以找到。

here

这里

. Part D is a 12-week study with an open-label extension including participants with oHCM and nHCM designed to explore dose response and optimization. The Company plans to report 12-week Part D data (oHCM and nHCM) in the second quarter of 2026 and initiate Phase 3 in the second half of 2026. To learn more about CIRRUS-HCM, visit clinicaltrials.gov, .

第D部分是一项为期12周的开放标签扩展研究，包括oHCM和nHCM患者，旨在探索剂量反应和优化。公司计划在2026年第二季度报告第D部分12周的数据（oHCM和nHCM），并在2026年下半年启动第三阶段。要了解有关CIRRUS-HCM的更多信息，请访问clinicaltrials.gov。

NCT06347159

。

EDG-15400 and heart failure:

EDG-15400 与心力衰竭：

EDG-15400 is a novel oral, selective, cardiac sarcomere modulator, targeted for the treatment of heart failure and other diseases of diastolic dysfunction. EDG-15400 is currently being evaluated in healthy adults in a Phase 1, randomized, double-blind, placebo-controlled, single and multiple ascending dose study evaluating safety, tolerability, pharmacokinetics and pharmacodynamics.

EDG-15400 是一种新型的口服、选择性心脏肌节调节剂，旨在治疗心力衰竭和舒张功能障碍相关疾病。目前，EDG-15400 正在健康成人中进行一项一期随机、双盲、安慰剂对照的单次和多次递增剂量研究，以评估其安全性、耐受性、药代动力学和药效学。

The Company expects to initiate a Phase 2 trial in participants with heart failure with preserved ejection fraction (HFpEF) in the second half of 2026. To learn more about this study, go to clinicaltrials.gov (.

公司预计将在2026年下半年启动针对射血分数保留的心力衰竭（HFpEF）患者的二期试验。如需了解更多关于本研究的信息，请访问clinicaltrials.gov。

NCT07177066

）。

First Quarter 2026 Financial Results

2026年第一季度财务业绩

Cash, cash equivalents and marketable securities

现金、现金等价物和可出售证券

were approximately $499.6 million as of March 31, 2026.

截至2026年3月31日，约为4.996亿美元。

Research and development (R&D) expenses

研发费用

were $42.7 million for the first quarter of 2026, compared to $36.8 million for the same period in 2025. The increase was primarily driven by increased clinical development activity related to EDG‑7500 and EDG‑15400, as well as higher internal personnel‑related costs to support the advancement of the Company's clinical‑stage programs.

2026年第一季度为4,270万美元，而2025年同期为3,680万美元。增长的主要原因是与EDG-7500和EDG-15400相关的临床开发活动增加，以及支持公司临床阶段项目进展的内部人员相关成本上升。

These increases were partially offset by lower sevasemten clinical program expenses due to timing of activity in the GRAND CANYON study and patient rollover into the MESA open‑label extension study..

这些增长部分被塞瓦森临床项目费用的减少所抵消，原因是大峡谷研究活动的时间安排以及患者转入MESA开放标签扩展研究。

General and Administrative (G&A) expenses

一般及行政（G&A）费用

were $11.5 million for the first quarter of 2026, compared to $9.2 million for the same period in 2025. The increase was primarily due to higher personnel‑related costs, including stock‑based compensation, as the Company expanded its organizational capabilities to support clinical development, as well as increased professional fees and other administrative costs..

2026年第一季度为1,150万美元，而2025年同期为920万美元。增长的主要原因是人员相关成本增加，包括基于股票的薪酬，因为公司扩展了其组织能力以支持临床开发，同时专业费用和其他管理成本也有所增加。

Net loss and net loss per share

净亏损和每股净亏损

were $49.0 million or $0.46 per share for the first quarter of 2026, compared to $40.8 million or $0.43 per share for the same period in 2025.

2026年第一季度为4900万美元，即每股0.46美元，而2025年同期为4080万美元，即每股0.43美元。

About Edgewise Therapeutics

关于Edgewise Therapeutics

Edgewise 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.

Edgewise Therapeutics是一家领先的肌肉疾病生物制药公司，专注于开发针对肌肉萎缩症和严重心脏疾病的新型疗法。公司在肌肉生理学方面的深厚专业知识推动了新一代创新治疗药物的发展。Sevasemten是一种口服的首创快速骨骼肌肌球蛋白抑制剂，目前正处于贝克尔和杜氏肌肉萎缩症的晚期临床试验阶段。

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.To learn more, go to .

EDG-7500 是一种新型的心脏肌节调节剂，用于治疗症状性肥厚型心肌病，目前处于二期临床开发阶段。EDG-15400 是一种新型的心脏肌节调节剂，用于治疗心力衰竭，目前处于一期临床开发阶段。Edgewise 的全体团队致力于我们的使命：改变受严重肌肉疾病影响的患者及其家庭的生活。欲了解更多信息，请访问。

edgewisetx.com

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Cautionary Note Regarding Forward-Looking Statements

关于前瞻性陈述的警告性说明

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 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 reporting data (including 12-week data on the CIRRUS-HCM trial, and the data from the GRAND CANYON trial; statements regarding Edgewise's potential marketing application in Becker; statements regarding sevasemten potentially being the first approved therapy for Becker; statements regarding the potential results of Edgewise's GRAND CANYON trial; statements regarding Edgewise's market opportunity; statements regarding Edgewise's plans to continue to collect longer-term open-label extension data for its LYNX and FOX Phase 2 trials; 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 participants with HFpEF; statements regarding Edgewise's ability to advance its pipeline; and statements by Edgewise's President and Chief Executive Officer. Words such as 'believes,' 'anticipates,' 'plans,' 'expects,' 'intends,' 'will,' 'goal,' '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条所定义的前瞻性陈述。本新闻稿中的非纯粹历史性的陈述为前瞻性陈述。这些前瞻性陈述包括但不限于关于Edgewise的产品候选药物和项目的潜力及预期的陈述，包括sevasemten、EDG-7500、EDG-15400及其心血管项目；关于Edgewise对其临床试验的预期陈述，包括数据报告的时间（包括CIRRUS-HCM试验的12周数据和GRAND CANYON试验的数据）；关于Edgewise在贝克尔病中潜在的市场应用陈述；关于sevasemten可能成为贝克尔病首个获批疗法的陈述；关于Edgewise的GRAND CANYON试验潜在结果的陈述；关于Edgewise市场机会的陈述；关于Edgewise计划继续收集LYNX和FOX 2期试验长期开放标签扩展数据的陈述；关于EDG-7500在肥厚型心肌病（HCM）中启动3期试验和EDG-15400在HFpEF患者中启动2期试验时间的陈述；关于Edgewise推进其产品管线能力的陈述；以及Edgewise总裁兼首席执行官的陈述。诸如“相信”、“预期”、“计划”、“预计”、“意图”、“将”、“目标”、“潜力”等词汇及类似表达旨在识别前瞻性陈述。此处包含的前瞻性陈述基于Edgewise的当前预期，并涉及可能永远不会实现或可能被证明为不正确的假设。

。

This press release contains hyperlinks to information that is not deemed to be incorporated by reference into this press release.

本新闻稿包含指向未被视为并入本新闻稿参考的信息的超链接。

Edgewise Therapeutics, Inc.

边缘疗法公司

Condensed Statement of Operations

综合损益表

(in thousands except share and per share amounts, unaudited)

（除股份和每股金额外，单位为千，未经审计）

Three months ended

三个月末

March 31, 2026