生物技术公司uniQure的股价在周三飙升了78%。此前该公司宣布，美国食品药品监督管理局（FDA）已转变立场，同意接受该公司早期试验的数据，用以支持其针对罕见遗传病亨廷顿病的基因疗法的上市申请提交。
FDA最初在2024年批准了总部位于阿姆斯特丹的uniQure，允许其在不进行通常所需的第三阶段临床试验的情况下提交上市申请。然而，到了2025年，该机构却改变了方向，尽管引用的数据与当初接受的数据相同。进入2026年初，FDA开始推动uniQure进行一项新的、长达数年的试验，该试验要求将患者随机分配接受真实疗法或安慰剂，之后才允许提交申请。周三的这一反转，距离Marty Makary卸任FDA局长一职仅一个多月，使得公司得以免去这项试验，直接提交申请。
Disclaimer: Investing carries risk. This is not financial advice. The above content should not be regarded as an offer, recommendation, or solicitation on acquiring or disposing of any financial products, any associated discussions, comments, or posts by author or other users should not be considered as such either. It is solely for general information purpose only, which does not consider your own investment objectives, financial situations or needs. TTM assumes no responsibility or warranty for the accuracy and completeness of the information, investors should do their own research and may seek professional advice before investing.