Shares of Humacyte, Inc. (HUMA) fell more than 10% in after-hours trading Friday after the Food and Drug Administration said it will require more time to review acellular tissue engineered vessel (ATEV) in the vascular trauma indication.The ATEV trauma program BLA was submitted to FDA in December 2023, and the FDA granted a Priority Review in February 2024 and assigned a PDUFA date of August 10, 2024.The company specified that FDA did not disclose a new PDUFA date.'FDA leadership noted that Humacyte's ATEV is a first-in-class product, and that Priority Review had been granted, which allows only a six-month review cycle, as compared to the standard ten-month review cycle for most products', said Laura Niklason, M.D., Ph.D., Chief Executive Officer of Humacyte.

在美国食品和药物管理局表示需要更多时间来审查血管创伤适应症中的无细胞组织工程血管（ATEV）后，Humacyte，Inc.（HUMA）的股价在周五盘后交易中下跌超过10%。ATEV创伤计划BLA于2023年12月提交给FDA，FDA于2024年2月批准了优先审查，并将PDUFA日期指定为2024年8月10日。该公司指定FDA没有披露新的PDUFA日期。”FDA领导层指出，Humacyte的ATEV是一流的产品，并且已获得优先审查，与大多数产品的标准十个月审查周期相比，只允许六个月的审查周期”，Humacyte首席执行官劳拉·尼克拉森（LauraNiklason）医学博士说。

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'During the course of the BLA review, the FDA has conducted inspections of our manufacturing facilities and clinical sites and has actively engaged with us in multiple discussions regarding our BLA filing, including post-marketing and labeling discussions. Based on these interactions, we are confident in the approvability of the ATEV in treating vascular trauma', she added.HUMA stock had closed at $7.91, down 1.13 percent on Friday.

“在BLA审查过程中，FDA对我们的生产设施和临床场地进行了检查，并积极与我们就我们的BLA申请进行了多次讨论，包括上市后和标签讨论。基于这些相互作用，我们相信ATEV在治疗血管创伤方面的可行性”，她补充道。HUMA股价周五收于7.91美元，下跌1.13%。

In after-hours, the shares further declined 10.38% to $7.09. For comments and feedback contact: editorial@rttnews.com.

盘后，该股进一步下跌10.38%，至7.09美元。如需评论和反馈，请联系：editorial@rttnews.com.

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