WILMINGTON, Del.--(BUSINESS WIRE)--Incyte (Nasdaq:INCY) today announced that it will pause enrollment in the ongoing Phase 2 study of MRGPRX2 (INCB000262) in chronic spontaneous urticaria (CSU). The decision was made following the observation of certain in vivo preclinical toxicology findings.

特拉华州威尔明顿（商业新闻短讯）--Incyte（纳斯达克：INCY）今天宣布，将暂停正在进行的慢性自发性荨麻疹（CSU）MRGPRX2（INCB000262）第二阶段研究的注册。该决定是在观察某些体内临床前毒理学发现后做出的。

These data have been shared with the U.S. Food and Drug Administration (FDA) and Incyte will work closely with the FDA to determine next steps.

这些数据已与美国食品和药物管理局（FDA）共享，Incyte将与FDA密切合作，以确定下一步。

Enrollment in the other INCB000262 proof-of-concept studies is complete and data from all clinical studies will help inform its future development and guide the potential development of back-up molecules.

其他INCB000262概念验证研究的注册已完成，所有临床研究的数据将有助于为其未来发展提供信息，并指导备用分子的潜在发展。

In addition, data from the Phase 2 study evaluating MRGPRX4 (INCB000547) in cholestatic pruritus (CP) does not support further development.

此外，评估胆汁淤积性瘙痒症（CP）中MRGPRX4（INCB000547）的2期研究数据不支持进一步发展。

About Incyte

关于Incyte

A global biopharmaceutical company on a mission to Solve On., Incyte follows the science to find solutions for patients with unmet medical needs. Through the discovery, development and commercialization of proprietary therapeutics, Incyte has established a portfolio of first-in-class medicines for patients and a strong pipeline of products in Oncology and Inflammation & Autoimmunity.

Incyte是一家全球生物制药公司，其使命是解决on问题，它遵循科学原理，为未满足医疗需求的患者寻找解决方案。通过专有疗法的发现、开发和商业化，Incyte为患者建立了一流的药物组合，并在肿瘤学、炎症和自身免疫领域建立了强大的产品线。

Headquartered in Wilmington, Delaware, Incyte has operations in North America, Europe and Asia..

Incyte总部位于特拉华州的威尔明顿，在北美、欧洲和亚洲都有业务。。

For additional information on Incyte, please visit Incyte.com or follow us on social media: LinkedIn, X, Instagram, Facebook, YouTube.

有关Incyte的更多信息，请访问Incyte.com或在社交媒体上关注我们：LinkedIn、X、Instagram、Facebook、YouTube。

Forward-Looking Statements

前瞻性声明

Except for the historical information set forth herein, the matters set forth in this press release contain predictions, estimates and other forward-looking statements, including any discussion of the ongoing Phase 2 study of MRGPRX2 (INCB000262), Incyte’s decision to pause enrollment in that study, Incyte’s intent to work with FDA to determine next steps, and future development of INCB000262 and other back-up molecules..

除了此处列出的历史信息外，本新闻稿中列出的事项还包含预测，估计和其他前瞻性陈述，包括对正在进行的MRGPRX2（INCB000262）第二阶段研究的任何讨论，Incyte决定暂停该研究的注册，Incyte打算与FDA合作确定下一步，以及INCB000262和其他备用分子的未来发展。。

These forward-looking statements are based on Incyte’s current expectations and subject to risks and uncertainties that may cause actual results to differ materially, including unanticipated developments in and risks related to: further research and development and the possibility that results of clinical trials will be negative and/or insufficient to meet applicable regulatory standards or warrant continued development; the ability to enroll sufficient numbers of subjects in clinical trials and the ability to enroll subjects in accordance with planned schedules; determinations made by FDA and other regulatory agencies; the efficacy or safety of Incyte’s products; the acceptance of Incyte’s products in the marketplace; market competition; unexpected variations in the supply of and/or demand for Incyte’s products; the effects of announced or unexpected price regulation or limitations on reimbursement or coverage for Incyte’s products; sales, marketing, manufacturing and distribution requirements, including Incyte’s ability to successfully commercialize and build commercial infrastructure for newly approved products and any additional products that become approved; greater than expected expenses, including expenses relating to litigation or strategic activities; variations in foreign currency exchange rates; and other risks detailed in Incyte’s reports filed with the Securities and Exchange Commission, including its quarterly report on form 10-Q for the quarter ended September 30, 2024.

这些前瞻性陈述基于Incyte目前的预期，并受到可能导致实际结果产生重大差异的风险和不确定性的影响，包括与以下方面相关的意外发展和风险：进一步的研究和开发以及临床试验结果可能为负和/或不足以满足适用的监管标准或保证持续发展；能够在临床试验中招募足够数量的受试者，并能够按照计划的时间表招募受试者；FDA和其他监管机构做出的决定；Incyte产品的功效或安全性；Incyte产品在市场上的接受程度；市场竞争；；宣布或意外的价格监管或限制对Incyte产品报销或保险范围的影响；销售、营销、制造和分销要求，包括Incyte成功商业化和为新批准的产品和任何获得批准的其他产品建立商业基础设施的能力；超出预期的费用，包括与诉讼或战略活动有关的费用；外币汇率变动；以及Incyte向美国证券交易委员会提交的报告中详述的其他风险，包括截至2024年9月30日的10-Q表季度报告。

Incyte disclaims any intent or obligation to update these forward-looking statements..

Incyte不承担更新这些前瞻性声明的任何意图或义务。。