智通财经APP获悉，周二，UniQure NV(QURE.US)开盘飙升超121%，一度触发熔断，报14.87美元。消息面上，作为uniQure的再生医学先进疗法(RMAT)Type b会议的一部分，FDA同意将正在进行的I/II期研究的数据与自然历史外部对照进行比较，可以作为加速批准路径下提交BLA的主要依据，从而避免额外的预提交研究。FDA还同意将cUHDRS作为中间临床终点，并且在脑脊液(CSF)中测量的神经纤维轻链(NfL)的减少可以作为加速批准申请中治疗效果的支持证据。
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