Regulatory Approval Drives Sharp Increase In Mesoblast (MESO) Shares
Regulatory Approval Drives Sharp Increase In Mesoblast (MESO) Shares
The company's top product candidate, Ryoncil, is an experimental treatment consisting of culture-expanded mesenchymal stromal cells taken from an unrelated donor's bone marrow and given intravenously over many infusions.Upon the announcement of the acceptance of Mesoblast Limited's (NASDAQ: MESO) licensing application by regulatory authorities, the company's shares have witnessed a significant rise on the US stock charts. The price of MESO shares increased by 9.27% to $8.25 as of the most recent check made during the current trading session.
监管机构宣布接受Mesoblast Limited（纳斯达克股票代码：MESO）的许可申请后，该公司的股票在美国股市排行榜上大幅上涨。截至本交易时段的最新支票，MESO股票的价格上涨了9.27％，至8.25美元。
Table of Contents
目录
- FDA Approves Mesoblast's Application
- Designations for Priority and Fast Track Reviews
- Implications for Ryoncil Approval
- FDA 批准 Mesoblast 的申请
- 优先审核和快速审核指定
- 对 Ryoncil 批准的影响
FDA Approves Mesoblast's Application
FDA 批准 Mesoblast 的申请
Mesoblast (MESO) said that their Biologics License Application (BLA) for resubmission has been accepted by the US Food and Drug Administration (FDA). Regarding Ryoncil, this BLA is intended for the treatment of pediatric patients with steroid-refractory acute graft versus host disease (SR-aGVHD).
Mesoblast（MESO）表示，他们重新提交的生物制剂许可证申请（BLA）已被美国食品药品监督管理局（FDA）接受。关于Ryoncil，该BLA旨在治疗类固醇难治性急性移植物抗宿主病（sr-AGVHD）的儿科患者。
The company's top product candidate, Ryoncil, is an experimental treatment consisting of culture-expanded mesenchymal stromal cells taken from an unrelated donor's bone marrow and given intravenously over many infusions.
该公司的主要候选产品Ryoncil是一种实验性疗法，由培养扩张的间充质基质细胞组成，该细胞取自非亲属捐赠者的骨髓，通过静脉注射多次输液。
Immunomodulatory characteristics of ryoncil work against the inflammatory pathways linked to SR-aGVHD. This is accomplished by preventing effector T cell activation and proliferation, reducing pro-inflammatory cytokine production, and promoting the migration of anti-inflammatory cells to impacted tissues.
ryoncil 的免疫调节特性对抗与 sr-AGVHD 相关的炎症途径。这是通过防止效应 t 细胞的激活和增殖、减少促炎细胞因子的产生以及促进抗炎细胞向受影响组织迁移来实现的。
Designations for Priority and Fast Track Reviews
优先审核和快速审核指定
Remetemcel-L, the active component of Ryoncil, has been given Fast Track status by the FDA, which will speed up the research and evaluation of treatments for severe illnesses with unmet medical needs.
Ryoncil的活性成分Remetemcel-L已被美国食品药品管理局授予快速通道地位，这将加快对医疗需求未得到满足的严重疾病治疗的研究和评估。
It has also been granted the Priority Review classification, which is given to medications that treat critical illnesses and provide considerable increases in either safety or efficacy above currently available therapies.
它还被授予优先审查分类，该分类适用于治疗严重疾病的药物，其安全性或疗效比目前可用的疗法大幅提高。
The FDA's approval of the resubmission is regarded as a full response, and Mesoblast hopes to hear back from the agency by January 7, 2025, the Prescription Drug User Fee Act's (PDUFA) deadline.
美国食品药品管理局批准重新提交的申请被视为全面回应，Mesoblast希望在2025年1月7日，即《处方药使用者费用法》（PDUFA）的最后期限之前收到该机构的回复。
In its resubmission on July 8, 2024, Mesoblast addressed the remaining Chemistry, Manufacturing, and Controls (CMC) issues in response to FDA input in March 2024 that said the clinical results from the Phase 3 trial MSB-GVHD001 looked good enough to warrant the BLA submission.
在2024年7月8日重新提交的文件中，Mesoblast回应了美国食品药品管理局在2024年3月提出的意见，即3期试验MSB-GVHD001的临床结果看起来足够好，足以证明提交BLA的理由，回应了剩余的化学、制造和控制（CMC）问题。
Moreover, no Form 483 was issued as a consequence of the FDA's Pre-License Inspection (PLI) of the remestemcel-L manufacturing process in May 2023.
此外，由于美国食品药品管理局于2023年5月对Remestemcel-L制造工艺进行了许可前检查（PLI），没有发布任何483表格。
Implications for Ryoncil Approval
对 Ryoncil 批准的影响
The FDA's acceptance of the BLA resubmission for review marks a critical step towards the potential approval of Ryoncil for treating children with SR-aGVHD, signifying a significant milestone for Mesoblast Limited.
美国食品和药物管理局接受BLA重新提交审查，这标志着Ryoncil可能批准用于治疗sr-AGVHD儿童方面迈出了关键一步，这标志着Mesoblast Limited的一个重要里程碑。