Why Is UniQure Stock Skyrocketing On Tuesday?
Why Is UniQure Stock Skyrocketing On Tuesday?
Huntington's disease is a rare, inherited neurodegenerative disorder that causes progressive motor dysfunction, cognitive decline, and behavioral changes.uniQure N.V. (NASDAQ:QURE) shares are rising following a significant development in its efforts to treat Huntington's disease.
UniQure N.V.（纳斯达克股票代码：QURE）的股价正在上涨，此前其治疗亨廷顿氏病的努力取得了重大进展。
The company has made a key breakthrough with its treatment, AMT-130. The company announced that the FDA has agreed on important elements for an accelerated approval pathway for AMT-130, a potential therapy aimed at slowing the disease's progression.
该公司的治疗方法AMT-130取得了关键突破。该公司宣布，美国食品药品管理局已经商定了加快AMT-130批准途径的重要内容，AMT-130是一种旨在减缓疾病进展的潜在疗法。
The FDA's decision followed discussions regarding data from ongoing Phase I/II clinical studies. The FDA has confirmed that the data, compared to a natural history control, can be used for the Biologics License Application (BLA), bypassing the need for additional pre-submission studies.
FDA的决定是在讨论正在进行的I/II期临床研究数据之后做出的。美国食品和药物管理局已经证实，与自然史对照相比，这些数据可以用于生物制剂许可证申请（BLA），无需进行额外的提交前研究。
Huntington's disease is a rare, inherited neurodegenerative disorder that causes progressive motor dysfunction, cognitive decline, and behavioral changes.
亨廷顿氏病是一种罕见的遗传性神经退行性疾病，可导致进行性运动功能障碍、认知能力下降和行为改变。
This latest agreement marks a crucial milestone for the Huntington's disease community, as AMT-130 could soon become a groundbreaking therapy.
这项最新协议标志着亨廷顿舞蹈症界的重要里程碑，因为AMT-130可能很快成为一种开创性的疗法。
The FDA also acknowledged reductions in neurofilament light chain (NfL), a biomarker of neurodegeneration, as supportive evidence of the therapy's potential benefits.
美国食品药品管理局还承认，神经变性的生物标志物神经丝轻链（nFL）的减少是该疗法潜在益处的支持性证据。
uniQure continues its efforts in advancing AMT-130, with BLA readiness activities underway and plans to engage further with the FDA in early 2025.
UniQure继续努力推进AMT-130，BLA准备活动正在进行中，并计划在2025年初与美国食品药品管理局进一步接触。
According to Benzinga Pro, QURE stock has gained over 2% in the past year. Investors can gain exposure to the stock via Virtus LifeSci Biotech Clinical Trials ETF (NYSE:BBC).
根据Benzinga Pro的数据，QURE的股票在过去一年中上涨了2％以上。投资者可以通过Virtus LifeSCI生物技术临床试验ETF（纽约证券交易所代码：BBC）获得股票敞口。
Price Action: QURE shares are trading higher by 87.8% to $13.70 in the premarket session on Tuesday.
价格走势：周二盘前交易中，QURE股价上涨87.8％，至13.70美元。
