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.（納斯達克股票代碼：QURE）的股價正在上漲，此前其治療亨廷頓氏病的努力取得了重大進展。
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.
該公司的治療方法AMT-130取得了關鍵突破。該公司宣佈，美國食品藥品管理局已經商定了加快AMT-130批准途徑的重要內容，AMT-130是一種旨在減緩疾病進展的潛在療法。
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的決定是在討論正在進行的I/II期臨床研究數據之後做出的。美國食品和藥物管理局已經證實，與自然史對照相比，這些數據可以用於生物製劑許可證申請（BLA），無需進行額外的提交前研究。
Huntington's disease is a rare, inherited neurodegenerative disorder that causes progressive motor dysfunction, cognitive decline, and behavioral changes.
亨廷頓氏病是一種罕見的遺傳性神經退行性疾病，可導致進行性運動功能障礙、認知能力下降和行爲改變。
This latest agreement marks a crucial milestone for the Huntington's disease community, as AMT-130 could soon become a groundbreaking therapy.
這項最新協議標誌着亨廷頓舞蹈症界的重要里程碑，因爲AMT-130可能很快成爲一種開創性的療法。
The FDA also acknowledged reductions in neurofilament light chain (NfL), a biomarker of neurodegeneration, as supportive evidence of the therapy's potential benefits.
美國食品藥品管理局還承認，神經變性的生物標誌物神經絲輕鏈（nFL）的減少是該療法潛在益處的支持性證據。
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繼續努力推進AMT-130，BLA準備活動正在進行中，並計劃在2025年初與美國食品藥品管理局進一步接觸。
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).
根據Benzinga Pro的數據，QURE的股票在過去一年中上漲了2％以上。投資者可以通過Virtus LifeSCI生物技術臨床試驗ETF（紐約證券交易所代碼：BBC）獲得股票敞口。
Price Action: QURE shares are trading higher by 87.8% to $13.70 in the premarket session on Tuesday.
價格走勢：週二盤前交易中，QURE股價上漲87.8％，至13.70美元。
