周一盘前，专注于遗传性神经肌肉疾病的临床阶段公司戴纳基（Dyne Therapeutics Inc，股票代码：DYN）股价大涨5.37%，引发投资者关注。
消息面上，戴纳基宣布其用于治疗杜氏肌营养不良症（DMD）的候选药物DYNE-251获得了美国食品药品监督管理局（FDA）的突破性疗法认定。这一认定是基于正在进行的DELIVER临床试验所产生的令人鼓舞的数据。突破性疗法认定将为DYNE-251提供多项优势，包括FDA的增强支持和加速审评时间表，这可能大大加快该药物的开发和上市进程。
戴纳基表示，公司计划在2026年初提交生物制品许可申请（BLA），寻求美国加速批准，同时也在美国以外地区寻求额外的批准途径。这一重大进展突显了DYNE-251作为下一代疗法的潜力，有望为DMD患者带来有意义的功能改善。投资者对这一积极发展反应热烈，推动了戴纳基股价的显著上涨，反映出市场对公司未来发展前景的乐观预期。
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