Solid Biosciences（SLDB）近日披露，公司计划在2026年上半年与美国食品药品监督管理局（FDA）举行后续会议，旨在就基因疗法SGT-003可能适用的加速批准路径获取进一步指导。
此次会议将聚焦于探讨SGT-003是否符合加速审批的资格标准，以及需要满足哪些监管要求。公司希望通过与FDA的深入沟通，明确后续临床开发及申报策略，为这款针对杜氏肌营养不良症（DMD）的潜在疗法铺平道路。
加速审批路径通常允许基于替代终点或中间临床终点提前批准用于严重疾病的药物，以更快满足患者需求。Solid Biosciences此举显示出其积极推进SGT-003研发进程的决心。
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