Mesoblast share price rockets 51%, receive positive FDA feedback on Remestemcel-L
Mesoblast share price rockets 51%, receive positive FDA feedback on Remestemcel-L
On Tuesday, $Mesoblast Ltd (MSB.AU)$ shares soared by over 51%, following the company announced receiving positive feedback from the FDA regarding Remestemcel-L.
星期二， $Mesoblast Ltd (MSB.AU)$ 該公司宣佈收到美國食品藥品管理局對Remestemcel-L的積極反饋後，股價飆升了51％以上。
The FDA has reviewed the phase 3 trial data and indicated that it supports the potential submission of a Biologics License Application (BLA) for the treatment of pediatric patients with steroid-refractory acute graft versus host disease.
美國食品藥品管理局已經審查了3期試驗數據，並表示支持可能提交的生物製劑許可申請（BLA），用於治療類固醇難治性急性移植物抗宿主病的兒科患者。
Mesoblast's CEO, Silviu Itescu, expressed his gratitude: “We thank the agency for their collaborative approach. The responses and guidance from FDA are clear and provide us with a high level of confidence to refile our BLA for remestemcel-L in children with SRaGVHD.”
Mesoblast的首席執行官西爾維烏·伊特斯庫表示感謝：“我們感謝該機構的合作方式。美國食品藥品管理局的回應和指導非常明確，這使我們有很高的信心爲sragVHD兒童重新申報Remestemcel-L的BLA。”
