- Veligrotug BLA accepted for thyroid eye disease (TED) with PDUFA target action date of June 30, 2026 under Priority Review; commercial preparations on track -

- Veligrotug BLA 获受理用于治疗甲状腺眼病（TED），PDUFA目标行动日期为2026年6月30日，进入优先审查；商业化准备按计划进行 -

- Topline phase 3 results for subcutaneous elegrobart (VRDN-003) on track for Q1 2026 for REVEAL-1 and Q2 2026 for REVEAL-2 for active and chronic TED, respectively -

- 皮下注射Elegrobart（VRDN-003）的3期顶线结果预计将于2026年第一季度针对REVEAL-1、2026年第二季度针对REVEAL-2分别用于活动性和慢性TED -

- IND submitted for half-life extended FcRn-inhibitor, VRDN-008; healthy volunteer (HV) data expected in 2H 2026 -

- 已提交IND申请，用于半衰期延长的FcRn抑制剂VRDN-008；预计健康志愿者（HV）数据将在2026年下半年获得 -

- Unveiling new program targeting thyroid-stimulating hormone receptor (TSHR); IND expected Q4 2026 -

- 揭幕针对促甲状腺激素受体（TSHR）的新项目；预计2026年第四季度提交IND -

- Cash position of approximately $888 million as of October 31, 2025 -

- 截至2025年10月31日，现金头寸约为8.88亿美元 -

- Company expects its current business plans to be funded through profitability -

- 公司预计其当前的业务计划将通过盈利能力获得资金 -

WALTHAM, Mass.--(BUSINESS WIRE)--

马萨诸塞州沃尔瑟姆--(BUSINESS WIRE)--

Viridian Therapeutics, Inc. (NASDAQ: VRDN), a biotechnology company focused on discovering, developing and commercializing potential best-in-class medicines for serious and rare diseases, today announces the company’s key priorities and anticipated catalysts for 2026.

Viridian Therapeutics, Inc.（纳斯达克股票代码：VRDN）是一家专注于发现、开发和商业化潜在的同类最佳药物以治疗严重和罕见疾病的生物技术公司，今天宣布了公司2026年的关键优先事项和预期催化剂。

“Following another year of strong execution across our portfolio, we enter 2026 positioned for meaningful value-creation and progress,” said Steve Mahoney, President and Chief Executive Officer of Viridian. “The FDA’s acceptance of the veligrotug BLA under Priority Review underscores the need for additional treatment options in TED and reinforces our conviction in veligrotug’s strong clinical profile.

“在我们投资组合中又一年的强劲执行之后，我们进入2026年，为实现有意义的价值创造和进展做好了准备，”Viridian总裁兼首席执行官史蒂夫·马奥尼表示。“FDA接受veligrotug的生物制品许可申请（BLA）并给予优先审查，突显了TED领域对更多治疗选择的需求，同时也加强了我们对veligrotug卓越临床表现的信心。”

Our priorities this year are clear: deliver pivotal topline data for elegrobart in Q1 and Q2, prepare for a potential mid‑year approval and launch of veligrotug, and advance our broader pipeline throughout with disciplined execution to create long-term value for patients and shareholders.”.

我们今年的重点很明确：在第一季度和第二季度为依利格鲁巴特提供关键的头条数据，为年中可能获批和推出的维利格鲁图格做好准备，并通过有纪律的执行推进我们更广泛的管道，为患者和股东创造长期价值。”

IGF‑1R Inhibitor Portfolio for TED Positioned for Transformational Impact in 2026

针对TED的IGF‑1R抑制剂组合有望在2026年产生变革性影响

Veligrotug BLA granted Priority Review; Prescription Drug User Fee Act (PDUFA) target date June 30, 2026

Veligrotug BLA获得优先审查；处方药用户收费法案（PDUFA）目标日期为2026年6月30日。

The veligrotug BLA, submitted in October 2025, is supported by positive data from two of the largest phase 3 clinical trials conducted in TED to date, THRIVE and THRIVE‑2 in active and chronic TED, respectively.

2025年10月提交的veligrotug BLA得到了迄今为止在TED中进行的两项最大规模的3期临床试验THRIVE和THRIVE‑2的积极数据支持，分别针对活动性和慢性TED。

Across active and chronic TED, following five infusions, veligrotug demonstrated rapid onset of treatment effect, clinically meaningful improvements in proptosis and diplopia, durable responses, and was generally well-tolerated.

在活动性和慢性TED患者中，经过五次输注后，veligrotug显示出治疗效果的快速起效、眼球突出和复视的临床显著改善、持久的反应，并且总体耐受性良好。

Priority Review designation is granted to applications for drugs that, if approved, would be a significant improvement in the safety or effectiveness of treating a serious condition.

优先审查资格授予那些如果获得批准，将在治疗严重疾病的安全性或有效性方面取得重大改进的药物申请。

Commercial and field medical affairs preparation continues in anticipation of a potential mid‑2026 U.S. launch. Sales, market access, patient services, and medical affairs leadership teams have been in place, and engagement is ongoing with a target core prescriber base of ~2,000 physicians in the annualizing $2 billion U.S.

商业和现场医疗事务准备正在继续，以预期2026年中可能的美国上市。销售、市场准入、患者服务和医疗事务领导团队已经就位，并正在与年度化20亿美元的美国市场中约2000名核心处方医生进行持续接触。

TED market..

TED市场。

Viridian is on track to submit a Marketing Authorization Application (MAA) to the European Medicines Agency in Q1 2026.

Viridian 计划在 2026 年第一季度向欧洲药品管理局提交上市许可申请 (MAA)。

Subcutaneous elegrobart (VRDN‑003) topline data on track for Q1 and Q2 2026

皮下注射Elegrobart（VRDN-003）的初步数据预计将在2026年第一季度和第二季度发布。

Topline data are expected in Q1 2026 for REVEAL‑1 (active TED) and Q2 2026 for REVEAL‑2 (chronic TED).

预计REVEAL-1（活跃期TED）的顶线数据将在2026年第一季度公布，REVEAL-2（慢性TED）的顶线数据将在2026年第二季度公布。

Enrollment in REVEAL‑1 and REVEAL‑2 completed in 2025, with each study exceeding target enrollment due to strong patient demand; the majority of patients in both studies were enrolled in the U.S.

2025年，REVEAL-1和REVEAL-2的注册完成，由于患者需求旺盛，每项研究的注册人数均超过了目标；两项研究中的大多数患者都在美国注册。

Elegrobart is being developed as a potential best-in-class subcutaneous anti-IGF-1R therapy for self-administration at home in a low‑volume autoinjector, with every-4-week or every-8-week dosing.

Elegrobart正在被开发为一种潜在的同类最佳皮下注射抗IGF-1R疗法，适用于在家使用低容量自动注射器自行给药，每4周或每8周一次。

Elegrobart is expected to be the only autoinjector for TED available at the time of anticipated launch.

预计Elegrobart将在预期上市时成为唯一可用的TED自动注射器。

Commercial infrastructure for veligrotug launch is expected to lay the groundwork for and to accelerate launch planning for elegrobart.

预计用于发射维利格罗 tug 的商业基础设施将为加速规划埃莱格罗巴特的发射奠定基础。

Expanding Viridian’s TED Pipeline with Potential Best-in-Class TSHR Program

扩大Viridian的TED管线，具有潜在的同类最佳TSHR项目

Announcing new TSHR inhibitor program with IND expected in Q4 2026

宣布新的TSHR抑制剂项目，预计2026年第四季度提交IND申请。

Viridian is advancing a potential best-in-class, half-life extended, monoclonal antibody that inhibits TSHR, designed for subcutaneous delivery in an autoinjector with the potential to support extended dosing intervals designed for patient convenience.

Viridian正在开发一种潜在的最佳同类、半衰期延长的单克隆抗体，该抗体抑制TSHR，设计用于通过自动注射器进行皮下给药，有可能支持为患者便利而设计的延长给药间隔。

Viridian expects to submit an IND for this program in Q4 2026.

Viridian 预计将在 2026 年第四季度为该计划提交 IND。

FcRn Portfolio Continues to Advance

FcRn产品组合持续取得进展

VRDN-006 achieved IgG reduction proof-of-concept in healthy volunteers

VRDN-006在健康志愿者中实现了IgG减少的概念验证

As previously disclosed, phase 1 healthy volunteer data demonstrated proof‑of‑concept IgG reduction in line with the FcRn inhibitor class and spared albumin and LDL. VRDN-006 was generally well-tolerated.

此前披露的数据显示，第一阶段健康志愿者数据证明了IgG减少的概念验证，这与FcRn抑制剂类一致，并且不影响白蛋白和LDL。VRDN-006通常具有良好的耐受性。

Viridian expects to communicate development plans for VRDN-006 in 2026.

Viridian预计将在2026年公布VRDN-006的开发计划。

VRDN-008 IND submitted in December 2025; phase 1 HV data expected in 2H 2026

VRDN-008 IND于2025年12月提交；预计2026年下半年获得一期健康志愿者数据

IND was submitted in December 2025; healthy volunteer data are expected in 2H 2026.

IND于2025年12月提交；健康志愿者数据预计在2026年下半年获得。

VRDN-008 is a bi-specific half-life extended FcRn inhibitor. As previously disclosed, after a single, high dose head-to-head study in non-human primates, VRDN-008 showed a longer half-life and more sustained IgG reduction versus efgartigimod.

VRDN-008是一种双特异性半衰期延长的FcRn抑制剂。如前所述，在非人类灵长类动物中进行的单次高剂量头对头研究后，VRDN-008显示出比efgartigimod更长的半衰期和更持久的IgG降低效果。

Well-Capitalized to Deliver on Priorities Through Profitability

资本充足，通过盈利能力实现优先事项

Viridian ended October 2025 with approximately $888 million in cash and investments.

Viridian在2025年10月结束时拥有约8.88亿美元的现金和投资。

Together with anticipated milestone payments from the DRI royalty agreement and anticipated future commercial revenues from veligrotug and elegrobart (if approved), the company expects to fund its current business plans through profitability.

公司预计，结合DRI特许权协议的预期里程碑付款以及veligrotug和elegrobart（如果获批）未来预期的商业收入，将能够为其当前的业务计划提供资金直至实现盈利。

About Viridian Therapeutics

关于Viridian Therapeutics

Viridian is a biopharmaceutical company focused on discovering, developing, and commercializing potential best-in-class medicines for patients with serious and rare diseases. Viridian’s expertise in antibody discovery and protein engineering enables the development of differentiated therapeutic candidates for previously validated drug targets in commercially established disease areas..

Viridian是一家生物制药公司，专注于为患有严重和罕见疾病的患者发现、开发和商业化潜在的最佳药物。Viridian在抗体发现和蛋白质工程方面的专业知识使其能够在商业上已确立的疾病领域中，针对先前已验证的药物靶点开发出具有差异化的治疗候选药物。

Viridian is advancing multiple late-stage, anti-insulin-like growth factor-1 receptor (IGF-1R) candidates in the clinic for the treatment of patients with thyroid eye disease (TED). The company conducted a pivotal program for veligrotug, including two global phase 3 clinical trials (THRIVE and THRIVE-2), to evaluate its efficacy and safety in patients with active and chronic TED.

Viridian公司正在临床中推进多个晚期抗胰岛素样生长因子-1受体（IGF-1R）候选药物，用于治疗甲状腺眼病（TED）患者。该公司开展了针对veligrotug的关键项目，包括两项全球III期临床试验（THRIVE和THRIVE-2），以评估其在活动性和慢性TED患者中的有效性和安全性。

Both THRIVE and THRIVE-2 reported positive topline data, meeting the primary and all secondary endpoints of each study. Viridian is also advancing elegrobart (VRDN-003) as a potential best-in-class subcutaneous therapy for the treatment of TED, including two ongoing global phase 3 pivotal clinical trials, REVEAL-1 and REVEAL-2, to evaluate the efficacy and safety of elegrobart in patients with active and chronic TED..

THRIVE 和 THRIVE-2 均报告了积极的顶线数据，达到了各自研究的主要终点和所有次要终点。Viridian 还正在推进 elegrobart（VRDN-003）作为一种潜在的同类最优皮下治疗药物，用于治疗 TED，包括两项正在进行的全球 3 期关键临床试验 REVEAL-1 和 REVEAL-2，以评估 elegrobart 在活动性和慢性 TED 患者中的疗效和安全性。

In addition to its IGF‑1R inhibitor portfolio, Viridian is developing an anti–thyroid‑stimulating hormone receptor (TSHR) program designed as a potential therapy for TED or Graves disease.

除了其IGF-1R抑制剂组合外，Viridian还在开发一种抗促甲状腺激素受体（TSHR）项目，旨在作为TED或格雷夫斯病的潜在疗法。

Viridian is also advancing a novel portfolio of neonatal Fc receptor (FcRn) inhibitors, including VRDN-006 and VRDN-008, which have the potential to be developed in multiple autoimmune diseases.

Viridian公司还在推进一个新颖的新生儿Fc受体（FcRn）抑制剂组合，包括VRDN-006和VRDN-008，这些药物有潜力在多种自身免疫疾病中开发。

Viridian is based in Waltham, Massachusetts. For more information, please visit

Viridian 总部位于马萨诸塞州沃尔瑟姆。欲了解更多信息，请访问

www.viridiantherapeutics.com

www.viridiantherapeutics.com

. Follow Viridian on

关注Viridian

LinkedIn

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Forward Looking Statements

前瞻性声明

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of words such as, but not limited to, “anticipate,” “believe,” “become,” “continue,” “could,” “design,” “estimate,” “expect,” “intend,” “may,” “might,” “on track,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” or “would” or other similar terms or expressions that concern our expectations, plans and intentions.

本新闻稿包含1995年《私人证券诉讼改革法案》意义下的前瞻性陈述。这些陈述可以通过使用诸如（但不限于）“预期”、“相信”、“成为”、“继续”、“可能”、“设计”、“估计”、“期望”、“意图”、“或许”、“可能”、“按计划进行”、“计划”、“潜力”、“预测”、“预计”、“应该”、“目标”、“将”或“会”等词语或其他类似的术语或表达来识别，这些词语或表达涉及我们的期望、计划和意图。

Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based on our current beliefs, expectations, and assumptions. Forward-looking statements include, without limitation, statements regarding: Viridian’s expectation that 2026 will be transformational; Viridian’s expectation for its current business plans to be funded through profitability; preclinical development, clinical development, and anticipated commercialization of Viridian’s product candidates veligrotug, elegrobart (formerly VRDN-003), VRDN-006, VRDN-008, and the TSHR inhibitor; anticipated data results and timing of their disclosure, including VRDN-003 topline data from the REVEAL-1 and REVEAL-2 trials in the first half of 2026 and VRDN-008 phase 1 healthy volunteer data in the second half of 2026; regulatory interactions and anticipated timing of regulatory submissions, including the anticipated MAA submission to the European Medicines Agency in the first quarter of 2026, and IND submission for the TSHR product candidate by year-end 2026, the PDUFA target action date based on Priority Review, and any other FDA designations; the potential utility, efficacy, potency, safety, clinical benefits, clinical response, convenience, and number of indications.

前瞻性声明既不是历史事实，也不是未来表现的保证。相反，它们是基于我们当前的信念、期望和假设。前瞻性声明包括但不限于以下内容：Viridian 预计 2026 年将是转型的一年；Viridian 预计其当前业务计划将通过盈利能力获得资金支持；veligrotug、elegrobart（原 VRDN-003）、VRDN-006、VRDN-008 和 TSHR 抑制剂等 Viridian 候选产品的临床前开发、临床开发及预期商业化；预期数据结果及其披露时间，包括 2026 年上半年 REVEAL-1 和 REVEAL-2 试验中 VRDN-003 的顶线数据，以及 2026 年下半年 VRDN-008 第一阶段健康志愿者的数据；监管互动及预期的监管提交时间，包括预计在 2026 年第一季度向欧洲药品管理局提交 MAA 申请，2026 年底前为 TSHR 候选产品提交 IND 申请，基于优先审查的 PDUFA 目标行动日期，以及任何其他 FDA 指定；潜在效用、疗效、效力、安全性、临床益处、临床反应、便利性及适应症数量。

New risks and uncertainties may emerge from time to time, and it is not possible to predict all risks and uncertainties. No representations or warranties (expressed or implied) are made about the accuracy of any such forward-looking statements. Such forward-looking statements are subject to a number of material risks and uncertainties including but not limited to: potential utility, efficacy, potency, safety, clinical benefits, clinical response, and convenience of Viridian’s product candidates; that results or data from completed or ongoing clinical trials may not be representative of the results of ongoing or future clinical trials; that preliminary data may not be representative of final data; the timing, progress and plans for our ongoing or future research, preclinical, and clinical development programs; changes to trial protocols for ongoing or new clinical trials; expectations and changes regarding the timing for regulatory filings; regulatory interactions; expectations and changes regarding the timing for enrollment and data; uncertainty and potential delays related to clinical drug development; the duration and impact of regulatory delays in our clinical programs; the timing of and our ability to obtain and maintain regulatory approvals for our therapeutic candidates; manufacturing risks; competition from other therapies or products; estimates of market size; other matters that could affect the sufficiency of existing cash, cash equivalents, and short-term investments to fund operations; our financial position and projected cash runway; our future operating results and financial performance; Viridian’s intellectual property position; the timing of preclinical and clinical trial activities and reporting results from same; that our product candidates may not be c.

新的风险和不确定性可能不时出现，无法预测所有风险和不确定性。对于任何此类前瞻性陈述的准确性，不作任何明示或暗示的声明或保证。此类前瞻性陈述受多种重大风险和不确定性的影响，包括但不限于：Viridian产品候选物的潜在效用、功效、效力、安全性、临床益处、临床反应和便利性；已完成或正在进行的临床试验的结果或数据可能无法代表正在进行或未来临床试验的结果；初步数据可能无法代表最终数据；我们正在进行或未来的研发、临床前和临床开发计划的时间、进展和规划；正在进行或新临床试验的试验方案变更；对监管文件时间的预期和变化；与监管机构的互动；对入组和数据时间的预期和变化；与临床药物开发相关的不确定性和潜在延迟；我们临床项目中监管延迟的持续时间和影响；我们获得和维持治疗候选物监管批准的时间和能力；生产风险；来自其他疗法或产品的竞争；市场规模的估计；可能影响现有现金、现金等价物和短期投资是否足以支持运营的其他事项；我们的财务状况和预计现金跑道；我们未来的运营结果和财务表现；Viridian的知识产权地位；临床前和临床试验活动的时机以及相关结果报告；我们的候选产品可能无法...

Investors

投资者

Greg Rossino

格雷格·罗西诺

grossino@viridiantherapeutics.com

grossino@viridiantherapeutics.com

Media

媒体

Lisa Lopez

丽莎·洛佩兹

llopez@viridiantherapeutics.com

llopez@viridiantherapeutics.com

Source: Viridian Therapeutics, Inc.

来源：Viridian Therapeutics, Inc.