FDA要求开展III期试验 uniQure(QURE.US)亨廷顿病基因疗法上市受阻股价重挫约33%

智通财经03-03

智通财经APP获悉，基因治疗公司uniQure(QURE.US)原本寄望其亨廷顿病候选药物AMT-130能获得美国FDA的加速批准，但这一期望近日落空。FDA明确告知这家生物制药公司，需开展一项随机、双盲、假手术对照的III期临床试验。受此消息影响，公司股价周一收盘大跌约33%。根据公司发布的新闻稿，uniQure此前计划基于一项与外部对照比较的I/II期研究数据申请批准。然而FDA认为，现有数据...

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