Solid Biosciences就SGT-003基因疗法治疗杜氏肌营养不良症与FDA达成C类会议积极共识

美股速递
Feb 09

Solid Biosciences(纳斯达克代码:SLDB)近日宣布,其针对杜氏肌营养不良症(DMD)研发的SGT-003基因疗法,在与美国食品药品监督管理局(FDA)举行的C类会议中获得了积极反馈。这一关键进展为该项目后续的临床开发计划清除了重要监管障碍。

FDA对SGT-003现有的临床前数据包表示了认可,并就下一阶段的临床试验设计提供了建设性指导。此次积极的监管互动标志着SGT-003项目向前迈出了实质性的一步,增强了其治疗DMD这一严重遗传性疾病的潜力。公司计划基于此次会议反馈,加快推进SGT-003的临床开发进程。

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