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.
監管機構宣佈接受Mesoblast Limited（納斯達克股票代碼：MESO）的許可申請後，該公司的股票在美國股市排行榜上大幅上漲。截至本交易時段的最新支票，MESO股票的價格上漲了9.27％，至8.25美元。
Table of Contents
目錄
- FDA Approves Mesoblast's Application
- Designations for Priority and Fast Track Reviews
- Implications for Ryoncil Approval
- FDA 批准 Mesoblast 的申請
- 優先審核和快速審核指定
- 對 Ryoncil 批准的影響
FDA Approves Mesoblast's Application
FDA 批准 Mesoblast 的申請
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，他們重新提交的生物製劑許可證申請（BLA）已被美國食品藥品監督管理局（FDA）接受。關於Ryoncil，該BLA旨在治療類固醇難治性急性移植物抗宿主病（sr-AGVHD）的兒科患者。
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.
該公司的主要候選產品Ryoncil是一種實驗性療法，由培養擴張的間充質基質細胞組成，該細胞取自非親屬捐贈者的骨髓，通過靜脈注射多次輸液。
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 的免疫調節特性對抗與 sr-AGVHD 相關的炎症途徑。這是通過防止效應 t 細胞的激活和增殖、減少促炎細胞因子的產生以及促進抗炎細胞向受影響組織遷移來實現的。
Designations for Priority and Fast Track Reviews
優先審核和快速審核指定
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已被美國食品藥品管理局授予快速通道地位，這將加快對醫療需求未得到滿足的嚴重疾病治療的研究和評估。
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.
它還被授予優先審查分類，該分類適用於治療嚴重疾病的藥物，其安全性或療效比目前可用的療法大幅提高。
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.
美國食品藥品管理局批准重新提交的申請被視爲全面回應，Mesoblast希望在2025年1月7日，即《處方藥使用者費用法》（PDUFA）的最後期限之前收到該機構的回覆。
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回應了美國食品藥品管理局在2024年3月提出的意見，即3期試驗MSB-GVHD001的臨床結果看起來足夠好，足以證明提交BLA的理由，回應了剩餘的化學、製造和控制（CMC）問題。
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，由於美國食品藥品管理局於2023年5月對Remestemcel-L製造工藝進行了許可前檢查（PLI），沒有發佈任何483表格。
Implications for Ryoncil Approval
對 Ryoncil 批准的影響
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.
美國食品和藥物管理局接受BLA重新提交審查，這標誌着Ryoncil可能批准用於治療sr-AGVHD兒童方面邁出了關鍵一步，這標誌着Mesoblast Limited的一個重要里程碑。