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uniQure NV

47.46

-0.9100-1.88%

Post-market: 47.460.00000.00%16:15 EDT

Volume:920.82K

Turnover:43.56M

Market Cap:3.29B

PE:-11.75

High:48.04

Open:48.00

Low:46.34

Close:48.37

52wk High:71.50

52wk Low:8.73

Shares:69.37M

Float Shares:57.53M

Volume Ratio:1.02

T/O Rate:1.60%

Dividend:- -

Dividend Rate:- -

EPS(TTM):-4.0399

EPS(LYR):-3.4602

ROE:-157.61%

ROA:-15.72%

PB:10.16

PE(LYR):-13.72

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Overview Company News Filings

uniQure Is Maintained at Outperform by Leerink Partners

UniQure's Approval Path Looks Stronger After US FDA Feedback, RBC Capital Markets Says

MT Newswires Live

uniQure price target raised to $70 from $36 at Leerink

Analysts Are Bullish on These Healthcare Stocks: uniQure (QURE), Biohaven Ltd. (BHVN)

uniQure upgraded to Overweight from Equal Weight at Barclays

RBC Raises Price Target on uniQure to $65 From $35, Keeps Outperform, Speculative Risk

MT Newswires Live

Uniqure Nv : Leerink Partners Raises Target Price to $70 From $36

THOMSON REUTERS

TD Cowen Sticks to Their Buy Rating for uniQure (QURE)

uniQure director Madhavan Balachandran disposes of USD 278,500 in common shares

Under the Radar: uniQure Shares Surge After FDA's Reversal on Gene Therapy -- WSJ

Top Midday Gainers

MT Newswires Live

uniQure upgraded to Overweight from Neutral at Cantor Fitzgerald

BUZZ-U.S. STOCKS ON THE MOVE-Jabil, BWX Technologies, Micron

UniQure Stock (QURE) Rockets on an FDA Update

This Biotech Stock Is Surging 66% on Surprise Good News From FDA -- Barrons.com

Uniqure Nv : Van Lanschot Kempen Raises Target Price to $60 From $27

THOMSON REUTERS

uniQure AMT-130 update ‘materially positive,’ says H.C. Wainwright

UniQure to Seek FDA Approval to Market Huntington's Disease Drug

uniQure announces plan for BLA submission for AMT-130

uniQure says FDA accepts Phase I/II data as basis for AMT-130 accelerated approval BLA

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The firm caught up with uniQ...","market":"us","thumbnail":null,"type":0,"news_type":0,"thumbnails":[],"rights":{"source":"tipranks_highlight","url":"https://www.tipranks.com/news/the-fly/uniqure-price-target-raised-to-70-from-36-at-leerink-thefly-news?utm_source=itigerup.com&utm_medium=referral","rn_cache_url":null,"directOrigin":true},"property":[],"language":"en","translate_title":"","themeId":null,"theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"https://www.tipranks.com/news/the-fly/uniqure-price-target-raised-to-70-from-36-at-leerink-thefly-news?utm_source=itigerup.com&utm_medium=referral","is_publish_highlight":false,"source_rank":0,"column":"","sentiment":"1","news_top_title":null,"news_tag":"","news_rank":0,"length":0,"strategy_id":0,"source":"tipranks_highlight","symbols":["LU0109394709.USD","QURE","LU0889565916.HKD","LU0320765992.SGD","BK4139"],"isVideo":false,"video":null,"gpt_icon":0},{"id":"2644088464","title":"Analysts Are Bullish on These Healthcare Stocks: uniQure (QURE), Biohaven Ltd. 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upgraded to Overweight from Equal Weight at Barclays","url":"https://stock-news.laohu8.com/highlight/detail?id=2644700705","media":"TIPRANKS","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2644700705?lang=en_us&edition=fundamental","pubTime":"2026-06-18 19:12","pubTimestamp":1781781152,"startTime":"0","endTime":"0","summary":"Barclays upgraded uniQure (QURE) to Overweight from Equal Weight with a $65 price target Published first on TheFly – the ultimate source for 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18:41","pubTimestamp":1781779270,"startTime":"0","endTime":"0","summary":null,"market":"fut","thumbnail":null,"type":0,"news_type":0,"thumbnails":[],"rights":null,"property":[],"language":"en","translate_title":"","themeId":null,"theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"https://api.refinitiv.com/data/news/v1/stories/urn:newsml:reuters.com:20260618:nFWN42Q0MF:1","is_publish_highlight":false,"source_rank":0,"column":"","sentiment":"0","news_top_title":null,"news_tag":"","news_rank":0,"length":0,"strategy_id":0,"source":"reuters_en_live","symbols":["QURE","LU0109394709.USD","LU0889565916.HKD","BK4139","LU0320765992.SGD"],"isVideo":false,"video":null,"gpt_icon":0},{"id":"2644691770","title":"TD Cowen Sticks to Their Buy Rating for uniQure (QURE)","url":"https://stock-news.laohu8.com/highlight/detail?id=2644691770","media":"TIPRANKS","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2644691770?lang=en_us&edition=fundamental","pubTime":"2026-06-18 14:55","pubTimestamp":1781765749,"startTime":"0","endTime":"0","summary":"In a report released yesterday, Joseph Thome from TD Cowen maintained a Buy rating on uniQure. The company’s shares closed yesterday at $48.16. Acc...","market":"nz","thumbnail":null,"type":0,"news_type":0,"thumbnails":[],"rights":{"source":"tipranks_highlight","url":"https://www.tipranks.com/news/blurbs/td-cowen-sticks-to-their-buy-rating-for-uniqure-qure-blurbs-news?utm_source=itigerup.com&utm_medium=referral","rn_cache_url":null,"directOrigin":true},"property":["rate"],"language":"en","translate_title":"","themeId":null,"theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"https://www.tipranks.com/news/blurbs/td-cowen-sticks-to-their-buy-rating-for-uniqure-qure-blurbs-news?utm_source=itigerup.com&utm_medium=referral","is_publish_highlight":false,"source_rank":0,"column":"","sentiment":"1","news_top_title":null,"news_tag":"","news_rank":0,"length":0,"strategy_id":0,"source":"tipranks_highlight","symbols":["TD","QURE","COWN"],"isVideo":false,"video":null,"gpt_icon":0},{"id":"2644724602","title":"uniQure director Madhavan Balachandran disposes of USD 278,500 in common shares","url":"https://stock-news.laohu8.com/highlight/detail?id=2644724602","media":"Reuters","labels":["insiderTrades"],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2644724602?lang=en_us&edition=fundamental","pubTime":"2026-06-18 05:02","pubTimestamp":1781730174,"startTime":"0","endTime":"0","summary":"uniQure director Balachandran Madhavan sold 10,000 ordinary shares on June 15, 2026 at a weighted average price of USD 27.85.The sale followed the exercise of stock options for 10,000 shares at USD 8.49 on the same day.Madhavan ended the day with 43,254 ordinary shares beneficially owned.Disclaimer: This news brief was created by Public Technologies  using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. uniQure NV published the original content used to generate this news brief via EDGAR, the Electronic Data Gathering, Analysis, and Retrieval system operated by the U.S. Securities and Exchange Commission , on June 17, 2026, and is solely responsible for the information contained therein.","market":"nz","thumbnail":null,"type":0,"news_type":0,"thumbnails":[],"rights":null,"property":[],"language":"en","translate_title":"","themeId":null,"theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"https://api.refinitiv.com/data/news/v1/stories/urn:newsml:reuters.com:20260617:nNDLtl6Bj:1","is_publish_highlight":false,"source_rank":0,"column":"","sentiment":"0","news_top_title":"uniQure director Madhavan Balachandran disposes of USD 278,500 in common shares","news_tag":"insiderTrades","news_rank":0,"length":0,"strategy_id":0,"source":null,"symbols":["LU0889565916.HKD","LU0109394709.USD","QURE","LU0320765992.SGD","BK4139"],"isVideo":false,"video":null,"gpt_icon":0},{"id":"2644045721","title":"Under the Radar: uniQure Shares Surge After FDA's Reversal on Gene Therapy -- WSJ","url":"https://stock-news.laohu8.com/highlight/detail?id=2644045721","media":"Dow Jones","labels":["productRelease"],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2644045721?lang=en_us&edition=fundamental","pubTime":"2026-06-18 04:48","pubTimestamp":1781729280,"startTime":"0","endTime":"0","summary":"Shares of biotech uniQure jumped 78% on Wednesday after it said the Food and Drug Administration had reversed itself and agreed to accept data from the company's early-stage trial to support an approval filing for its gene therapy for a rare inherited condition called Huntington's disease.The FDA first gave Amsterdam-based uniQure the go-ahead to submit its application for approval without running a Phase 3 trial-which is what is typically needed for such a submission-in 2024. The agency reversed course in 2025, citing the same data it had once accepted. By early 2026, it was pushing uniQure toward a new, yearslong trial that would randomly assign patients to the real therapy or a placebo before allowing any filing. Wednesday's reversal, which comes just over a month after the departure of Marty Makary as FDA Commissioner, allows the company to file without that trial.This item is part of a Wall Street Journal live coverage event. The full stream can be found by searching P/WSJL .","market":"other","thumbnail":null,"type":0,"news_type":0,"thumbnails":[],"rights":null,"property":[],"language":"en","translate_title":"","themeId":null,"theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"https://dowjonesnews.com/newdjn/logon.aspx?AL=N","is_publish_highlight":false,"source_rank":0,"column":"","sentiment":"2","news_top_title":null,"news_tag":"productRelease","news_rank":0,"length":0,"strategy_id":0,"source":null,"symbols":["QURE","BK4585","LU0889565916.HKD","LU0320765992.SGD","BK4139","LU0109394709.USD","BK4588","LABU"],"isVideo":false,"video":null,"gpt_icon":0},{"id":"2644723557","title":"Top Midday Gainers","url":"https://stock-news.laohu8.com/highlight/detail?id=2644723557","media":"MT Newswires Live","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2644723557?lang=en_us&edition=fundamental","pubTime":"2026-06-18 01:40","pubTimestamp":1781718018,"startTime":"0","endTime":"0","summary":"AstroNova  signed an agreement to be acquired by Arcline Investment Management for $29 per share in an all-cash deal with an enterprise value of about $272 million, it said Wednesday.Shares surged 70% as intraday trading volume jumped to over 1.77 million from a daily average of about 56,000.uniQure's  shares soared 75% amid heavy trading after the company said Wednesday it intends to submit a Biologics License Application for the accelerated approval of AMT-130 to treat Huntington's disease in Q3.Intraday trading volume climbed to more than 13.8 million from a daily average of roughly 1.75 million.La-Z-Boy's  reported overnight a year-over-year gain in fiscal Q4 earnings and said it expects sales to outperform the industry in the ongoing quarter.Shares jumped past 19% following an increase in intraday trading volume to over 1.77 million from a daily average of about 413,000.Price: 28.35, Change: +11.66, Percent Change: +69.88","market":"sh","thumbnail":null,"type":0,"news_type":0,"thumbnails":[],"rights":null,"property":[],"language":"en","translate_title":"","themeId":null,"theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"https://www.mtnewswires.com/","is_publish_highlight":false,"source_rank":0,"column":"","sentiment":"0","news_top_title":null,"news_tag":"","news_rank":0,"length":0,"strategy_id":0,"source":"mtnewswires_news","symbols":["BK4170","BK4139","LZB","LU0889565916.HKD","BK4095","LU0320765992.SGD","LU0109394709.USD","QURE","ALOT","BK4516"],"isVideo":false,"video":null,"gpt_icon":0},{"id":"2644740581","title":"uniQure upgraded to Overweight from Neutral at Cantor Fitzgerald","url":"https://stock-news.laohu8.com/highlight/detail?id=2644740581","media":"TIPRANKS","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2644740581?lang=en_us&edition=fundamental","pubTime":"2026-06-17 23:45","pubTimestamp":1781711156,"startTime":"0","endTime":"0","summary":"Cantor Fitzgerald analyst Kristen Kluska upgraded uniQure (QURE) to Overweight from Neutral. Published first on TheFly – the ultimate source for re...","market":"fut","thumbnail":null,"type":0,"news_type":0,"thumbnails":[],"rights":{"source":"tipranks_highlight","url":"https://www.tipranks.com/news/the-fly/uniqure-upgraded-to-overweight-from-neutral-at-cantor-fitzgerald-thefly-news?utm_source=itigerup.com&utm_medium=referral","rn_cache_url":null,"directOrigin":true},"property":[],"language":"en","translate_title":"","themeId":null,"theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"https://www.tipranks.com/news/the-fly/uniqure-upgraded-to-overweight-from-neutral-at-cantor-fitzgerald-thefly-news?utm_source=itigerup.com&utm_medium=referral","is_publish_highlight":false,"source_rank":0,"column":"","sentiment":"1","news_top_title":null,"news_tag":"","news_rank":0,"length":0,"strategy_id":0,"source":"tipranks_highlight","symbols":["QURE","LU0109394709.USD","LU0320765992.SGD","BK4139","LU0889565916.HKD"],"isVideo":false,"video":null,"gpt_icon":0},{"id":"2644751747","title":"BUZZ-U.S. STOCKS ON THE MOVE-Jabil, BWX Technologies, Micron","url":"https://stock-news.laohu8.com/highlight/detail?id=2644751747","media":"Reuters","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2644751747?lang=en_us&edition=fundamental","pubTime":"2026-06-17 23:42","pubTimestamp":1781710974,"startTime":"0","endTime":"0","summary":"BUZZ-U.S. STOCKS ON THE MOVE-Jabil, BWX Technologies, MicronWorkspace search string for individual stock moves: STXBZThe Day Ahead newsletter: https://refini.tv/3LI4BU7The Morning News Call newsletter","market":"fut","thumbnail":null,"type":0,"news_type":0,"thumbnails":[],"rights":null,"property":[],"language":"en","translate_title":"","themeId":null,"theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"https://api.refinitiv.com/data/news/v1/stories/urn:newsml:reuters.com:20260617:nL6N42P12K:1","is_publish_highlight":false,"source_rank":0,"column":"","sentiment":"0","news_top_title":null,"news_tag":"","news_rank":0,"length":0,"strategy_id":0,"source":null,"symbols":["MU","KLAG","ASTS","BIRD","VSTM","AMAT","PTRN","CVNA","ICCM","INTC","TGE","WNC","SOPH","SHAZ","SNBRQ","ADTX","LZB","HOOX","CVNX","KMX","LRCX","BWXT","SATG","CME","EHGO","SVAQ","DSX","JBL","SNBR","WBX","SKIL","TXG","KLAC","LDOS","ASTN","LRCU","HOOD","HOOY","ADPT","QURE","WDC","ASTX","INTW","ECHO","LINT","MUU","INLF","NEO","SATS","GNK","HOOI","FTHM"],"isVideo":false,"video":null,"gpt_icon":0},{"id":"2644742749","title":"UniQure Stock (QURE) Rockets on an FDA Update","url":"https://stock-news.laohu8.com/highlight/detail?id=2644742749","media":"TIPRANKS","labels":["policyRegulatory"],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2644742749?lang=en_us&edition=fundamental","pubTime":"2026-06-17 22:56","pubTimestamp":1781708164,"startTime":"0","endTime":"0","summary":"UniQure stock was up on Wednesday after the company announced an updated from the FDA.","market":"nz","thumbnail":null,"type":0,"news_type":0,"thumbnails":[],"rights":{"source":"tipranks_highlight","url":"https://www.tipranks.com/news/uniqure-stock-qure-rockets-on-an-fda-update?utm_source=itigerup.com&utm_medium=referral","rn_cache_url":null,"directOrigin":true},"property":[],"language":"en","translate_title":"","themeId":null,"theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"https://www.tipranks.com/news/uniqure-stock-qure-rockets-on-an-fda-update?utm_source=itigerup.com&utm_medium=referral","is_publish_highlight":false,"source_rank":0,"column":"","sentiment":"2","news_top_title":null,"news_tag":"policyRegulatory","news_rank":0,"length":0,"strategy_id":0,"source":"tipranks_highlight","symbols":["LU0109394709.USD","LU0320765992.SGD","QURE","BK4588","LU0889565916.HKD","LABU","BK4585","BK4139"],"isVideo":false,"video":null,"gpt_icon":0},{"id":"2644573744","title":"This Biotech Stock Is Surging 66% on Surprise Good News From FDA -- Barrons.com","url":"https://stock-news.laohu8.com/highlight/detail?id=2644573744","media":"Dow Jones","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2644573744?lang=en_us&edition=fundamental","pubTime":"2026-06-17 22:10","pubTimestamp":1781705400,"startTime":"0","endTime":"0","summary":"Gene therapy company uniQure has faced a brutal uphill battle to commercialize its experimental treatment for Huntington's disease, but its outlook suddenly has brightened.Shares of the Amsterdam-based biopharmaceutical company surged 66% on Wednesday after uniQure said it would seek regulatory approval to bring its gene therapy candidate, AMT-130, to market.The Food and Drug Administration has cleared uniQure to submit a Biologics License Application for the drug, the company said. A BLA is a formal request to market and distribute a medical product derived from living organisms across state lines.The FDA's position is an about-face. Months ago, the agency declared that uniQure's Phase I and II data wasn't enough to support a BLA, and as recently as March the agency suggested running another study. In a recent meeting, however, the FDA reversed course, telling uniQure that a three-year analysis of those same Phase I and II trials can now serve as the primary basis for their applicatio","market":"sh","thumbnail":null,"type":0,"news_type":0,"thumbnails":[],"rights":null,"property":[],"language":"en","translate_title":"","themeId":null,"theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"https://dowjonesnews.com/newdjn/logon.aspx?AL=N","is_publish_highlight":false,"source_rank":0,"column":"","sentiment":"2","news_top_title":null,"news_tag":"","news_rank":0,"length":0,"strategy_id":0,"source":null,"symbols":["XBI","LU0109394709.USD","BK4585","LABU","BK4581","LU0889565916.HKD","BK4139","LU0320765992.SGD","QURE","BK4588"],"isVideo":false,"video":null,"gpt_icon":0},{"id":"2644741508","title":"Uniqure Nv : Van Lanschot Kempen Raises Target Price to $60 From $27","url":"https://stock-news.laohu8.com/highlight/detail?id=2644741508","media":"THOMSON REUTERS","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2644741508?lang=en_us&edition=fundamental","pubTime":"2026-06-17 21:40","pubTimestamp":1781703617,"startTime":"0","endTime":"0","summary":null,"market":"us","thumbnail":null,"type":0,"news_type":0,"thumbnails":[],"rights":null,"property":[],"language":"en","translate_title":"","themeId":null,"theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"https://api.refinitiv.com/data/news/v1/stories/urn:newsml:reuters.com:20260617:nFWN42P06C:1","is_publish_highlight":false,"source_rank":0,"column":"","sentiment":"0","news_top_title":null,"news_tag":"","news_rank":0,"length":0,"strategy_id":0,"source":"reuters_en_live","symbols":["LU0889565916.HKD","QURE","LU0320765992.SGD","LU0109394709.USD","BK4139"],"isVideo":false,"video":null,"gpt_icon":0},{"id":"2644749742","title":"uniQure AMT-130 update ‘materially positive,’ says H.C. 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Wainwright analyst Patrick Trucchio reiterates a Buy rating on uniQure (QURE) after the company announced that, during a recent Type B meeting...","market":"nz","thumbnail":null,"type":0,"news_type":0,"thumbnails":[],"rights":{"source":"tipranks_highlight","url":"https://www.tipranks.com/news/the-fly/uniqure-amt-130-update-materially-positive-says-h-c-wainwright-thefly-news?utm_source=itigerup.com&utm_medium=referral","rn_cache_url":null,"directOrigin":true},"property":[],"language":"en","translate_title":"","themeId":null,"theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"https://www.tipranks.com/news/the-fly/uniqure-amt-130-update-materially-positive-says-h-c-wainwright-thefly-news?utm_source=itigerup.com&utm_medium=referral","is_publish_highlight":false,"source_rank":0,"column":"","sentiment":"1","news_top_title":null,"news_tag":"dataReport","news_rank":0,"length":0,"strategy_id":0,"source":"tipranks_highlight","symbols":["BK4084","BK4534","LU0889565916.HKD","BK4139","BK4585","LU0109394709.USD","BK4588","BK4581","BK4554","QURE","LU0320765992.SGD","BK4219","AMT"],"isVideo":false,"video":null,"gpt_icon":0},{"id":"2644272743","title":"UniQure to Seek FDA Approval to Market Huntington's Disease Drug","url":"https://stock-news.laohu8.com/highlight/detail?id=2644272743","media":"Dow Jones","labels":["productRelease"],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2644272743?lang=en_us&edition=fundamental","pubTime":"2026-06-17 19:41","pubTimestamp":1781696460,"startTime":"0","endTime":"0","summary":"UniQure said it plans to apply for regulatory approval to market one of its primary investigational gene therapies as a treatment for Huntington's disease.During a recent meeting with the Food and Drug Administration, the agency told the company that a three-year analysis from a study of UniQure's AMT-130 drug would be acceptable as the primary basis for a Biologics License Application to accelerate approval of the drug in Huntington's disease, UniQure said.The FDA is also seeking to align on the design of a confirmatiory study prior to the submission of the application, the company said.UniQure said it is committed to conducting the confirmatory study without delay and expects to align with the FDA on the details. It aims to submit the application in the third quarter of this year.","market":"sg","thumbnail":null,"type":0,"news_type":0,"thumbnails":[],"rights":null,"property":[],"language":"en","translate_title":"","themeId":null,"theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"https://dowjonesnews.com/newdjn/logon.aspx?AL=N","is_publish_highlight":false,"source_rank":0,"column":"","sentiment":"1","news_top_title":null,"news_tag":"productRelease","news_rank":0,"length":0,"strategy_id":0,"source":null,"symbols":["BK4588","BK4585","BK4139","LU0889565916.HKD","LABU","LU0109394709.USD","QURE","LU0320765992.SGD"],"isVideo":false,"video":null,"gpt_icon":0},{"id":"2644585743","title":"uniQure announces plan for BLA submission for AMT-130","url":"https://stock-news.laohu8.com/highlight/detail?id=2644585743","media":"TIPRANKS","labels":["productRelease"],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2644585743?lang=en_us&edition=fundamental","pubTime":"2026-06-17 19:10","pubTimestamp":1781694612,"startTime":"0","endTime":"0","summary":"uniQure (QURE) announced that, during a recent Type B meeting with the FDA, the FDA communicated that the three-year analysis from the Phase I/II s...","market":"fut","thumbnail":null,"type":0,"news_type":0,"thumbnails":[],"rights":{"source":"tipranks_highlight","url":"https://www.tipranks.com/news/the-fly/uniqure-announces-plan-for-bla-submission-for-amt-130-thefly-news?utm_source=itigerup.com&utm_medium=referral","rn_cache_url":null,"directOrigin":true},"property":[],"language":"en","translate_title":"","themeId":null,"theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"https://www.tipranks.com/news/the-fly/uniqure-announces-plan-for-bla-submission-for-amt-130-thefly-news?utm_source=itigerup.com&utm_medium=referral","is_publish_highlight":false,"source_rank":0,"column":"","sentiment":"1","news_top_title":null,"news_tag":"productRelease","news_rank":0,"length":0,"strategy_id":0,"source":"tipranks_highlight","symbols":["AMT","QURE","BK4585","LU0109394709.USD","BK4534","BK4084","LU0320765992.SGD","LU0889565916.HKD","BK4139","LABU","BK4581","BK4588","BK4219","BK4554"],"isVideo":false,"video":null,"gpt_icon":0},{"id":"2644482227","title":"uniQure says FDA accepts Phase I/II data as basis for AMT-130 accelerated approval BLA","url":"https://stock-news.laohu8.com/highlight/detail?id=2644482227","media":"Reuters","labels":["policyRegulatory"],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2644482227?lang=en_us&edition=fundamental","pubTime":"2026-06-17 19:05","pubTimestamp":1781694320,"startTime":"0","endTime":"0","summary":"uniQure plans to submit a BLA in Q3 2026 seeking FDA accelerated approval for AMT-130 in Huntington’s disease.FDA indicated the Phase I/II 3-year analysis could support the filing as the primary basis for review.Agency wants alignment on the confirmatory study design before submission, including a concurrent standard-of-care control instead of a sham procedure.","market":"fut","thumbnail":null,"type":0,"news_type":0,"thumbnails":[],"rights":null,"property":[],"language":"en","translate_title":"","themeId":null,"theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"https://api.refinitiv.com/data/news/v1/stories/urn:newsml:reuters.com:20260617:nNDL10hJX1:1","is_publish_highlight":false,"source_rank":0,"column":"","sentiment":"1","news_top_title":null,"news_tag":"policyRegulatory","news_rank":0,"length":0,"strategy_id":0,"source":null,"symbols":["BK4585","LU2095319765.USD","LU2210149790.SGD","IE00BKPKM429.USD","LU0889565916.HKD","SG9999014013.SGD","IE00BGHQF748.EUR","IE00BN0W2V16.EUR","LU0314104364.USD","QURE","SG9999014039.USD","BK4588","IE00BN0W2T93.GBP","IE00B3QW5Z07.USD","SG9999014005.SGD","NDAQ","LU0109394709.USD","IE00BN0W2W23.USD","IE00B64PRP62.GBP","BK4139","SG9999014021.USD","BK4112","LU2210150020.SGD","LU0320765992.SGD"],"isVideo":false,"video":null,"gpt_icon":0}],"pageSize":20,"totalPage":9,"pageCount":3,"totalSize":166,"code":"91000000","status":"200"}]}}