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NASDAQ:QURE 24 September 2025 - 18 June 2026

uniQure Gets Go-Ahead From FDA for AMT-130 Huntington’s Gene Therapy Application

uniQure shares steady after FDA momentum, Huntington’s filing on radar

uniQure N.V. shares on the Nasdaq held much of Wednesday’s big jump in premarket trade Thursday. The U.S. FDA has cleared a route for the Netherlands-based gene-therapy firm to pursue approval of its experimental Huntington’s disease drug, AMT-130. The stock finished at $48.16 on Wednesday, climbing 78.4% from $26.99 a day before. uniQure says the news is key right now since AMT-130 is its main pipeline asset and there’s no approved drug for Huntington’s disease that puts off symptoms or slows things down. Huntington’s is a genetic brain disease causing movement problems, mental decline, and changes in behavior.
18 June 2026
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uniQure Gets Go-Ahead From FDA for AMT-130 Huntington’s Gene Therapy Application

uniQure Gets Go-Ahead From FDA for AMT-130 Huntington’s Gene Therapy Application

uniQure said Wednesday the U.S. Food and Drug Administration will let it use three-year data from its early Huntington’s gene therapy trial as the basis for an accelerated approval filing, changing course in the dragged-out regulatory battle over the therapy. The company will go ahead with a biologics license application in the third quarter. That application is the standard FDA process for marketing a biologic drug in the U.S. The move is significant now as it gives AMT-130 a U.S. path forward in the near term, after the agency earlier cast doubt on whether its overall data would be enough for an approval filing. Reuters said FDA officials late last year saw the data as lacking, and quoted a senior regulator who called the therapy a “failed product.”
17 June 2026
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Atara Biotherapeutics Stock Jumps 18% as FDA Shake-Up Puts Ebvallo Back in Focus

Atara Biotherapeutics Stock Jumps 18% as FDA Shake-Up Puts Ebvallo Back in Focus

Atara Biotherapeutics jumped roughly 18% late Monday morning, rallying alongside other rare-disease biotech stocks after word got out that the FDA’s head of biologics is set to depart next month. uniQure picked up about 15%, while Regenxbio climbed close to 20%. This is significant: Atara remains in pursuit of a U.S. route for EBVALLO, also known as tabelecleucel, a cell therapy targeting Epstein-Barr virus-positive post-transplant lymphoproliferative disease. The condition—rare, frequently deadly—can turn up after organ or stem-cell transplants, and, right now, there are no approved therapies for it in the U.S.
9 March 2026
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uniQure stock jolts higher again after FDA biologics chief set to exit

uniQure stock jolts higher again after FDA biologics chief set to exit

uniQure shares surged roughly 34% to $14.27 in U.S. premarket action on Monday, following reports that the FDA’s vaccines and biologics chief plans to exit in April. The stock had already leapt 57% after hours on Friday after the initial report. This goes beyond a staffing shuffle. uniQure is scrambling to keep its U.S. submission for AMT-130 alive. The FDA has told the company its Phase 1/2 results, stacked up against an external control arm, won’t cut it for a marketing application.
9 March 2026
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uniQure (QURE) Stock Jumps in Pre-Market on Dec. 16, 2025: FDA AMT-130 Uncertainty, Analyst Price Targets, and Key Catalysts Ahead

uniQure (QURE) Stock Jumps in Pre-Market on Dec. 16, 2025: FDA AMT-130 Uncertainty, Analyst Price Targets, and Key Catalysts Ahead

Dec. 16, 2025 — uniQure N.V. is back in the spotlight Tuesday after a notable extended-hours rebound. The gene therapy developer’s shares were highlighted among top pre-market gainers, rising about 15% to roughly $23.50 in early trading, following a strong after-hours move the prior session. StockAnalysis+1 The snapback comes at a time when the fundamental narrative around uniQure remains dominated by one big question: how the U.S. FDA will allow AMT-130—uniQure’s Huntington’s disease gene therapy—to move toward a Biologics License Application after the agency signaled the current evidence package is not sufficient as “primary” support for approval. GlobeNewswire+1
16 December 2025
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UniQure’s Roller-Coaster: Gene Therapy Breakthrough, FDA Setback, and What’s Next for QURE Stock

UniQure’s Roller-Coaster: Gene Therapy Breakthrough, FDA Setback, and What’s Next for QURE Stock

UniQure’s stock has been on a wild ride in 2025. After starting the year in the mid-teens, QURE shares skyrocketed through mid-2025 on hopes for its Huntington’s gene therapy. The rally hit a fever pitch in late September when Phase 1/2 trial data showed a remarkable 75% reduction in disease progression with AMT-130 – news that caused the stock to surge almost 200% that monthreuters.com. By late October, QURE was hovering around $68–$70, up roughly 300–500% from spring levels. However, in the past few days the stock’s momentum sharply reversed. On Monday, Nov 3, 2025, UniQure revealed a major FDA setback that sent investors fleeing. Shares plunged ~60–67% in a single session, collapsing from the high-$60s to the low-$20smarketbeat.com. In pre-market trading that morning, QURE was down over 58% on the newsreuters.com, and by mid-day it traded around $23. This wipeout has essentially “reset” the stock to its levels from early September, erasing much of the Huntington’s euphoria. Volatility remains extreme – a true roller-coaster for investors. Notably, even after this crash, QURE is still above where it began 2025, reflecting how far it had run up prior to the news. The recent collapse underscores the binary risk inherent in
3 November 2025
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uniQure (QURE) Stock Soars on Huntington’s Breakthrough – Key Facts & 2025 Outlook

A One‑Time Brain Gene Therapy Just Slowed Huntington’s by 75%—Is This the Turning Point Families Have Waited For?

What it is. HD is a progressive brain disorder that typically begins in mid‑adulthood, causing a mix of movement, cognitive and psychiatric symptoms. It is uniformly fatal over years to decades. NIH Neurological Institute+1 Genetics. HD is autosomal dominant: each child of an affected parent has a 50% chance to inherit the expansion. The disease is caused by CAG repeat expansion in HTT: ≥40 repeats almost always cause disease in a normal lifespan; 36–39 have reduced penetrance; 27–35 are intermediate. Anticipation—earlier onset in successive generations—occurs, especially with paternal transmission. NCBI+1
26 September 2025
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uniQure (QURE) Stock Soars on Huntington’s Breakthrough – Key Facts & 2025 Outlook

Gene Therapy Breakthrough: uniQure’s QURE Stock Skyrockets on Huntington’s Triumph

uniQure’s stock performance in 2025 has been remarkably strong, capped by the explosive move on Sep. 24 after the Huntington’s data release. Prior to the announcement, QURE was trading in the mid-teens ts2.tech – already up over 100% year-to-date as anticipation for the trial results built. When the pivotal results hit, trading was halted pre-market due to pending news ts2.tech. Once the halt lifted, the stock opened dramatically higher and at one point reached the mid-$40s per share, up nearly 160–200% in a single session pharmaphorum.com. It eventually closed with a gain of around 150%+ on the day investing.com. This massive one-day jump is one of the biotech sector’s biggest of 2025, reflecting how transformational the news was for uniQure’s outlook. Such a rally vastly increased uniQure’s market capitalization – from roughly $750–800 million before the data to about $2.5–3 billion afterward finance.yahoo.com. Even after this surge, analysts note the valuation still “assigns limited credit” for AMT-130’s full potential ts2.tech. At ~$2.5B market cap, investors are pricing in some probability of success, but not the entirety of a Huntington’s gene therapy addressable market which could translate to blockbuster revenues if approved ts2.tech. For context, Bluebird Bio – another gene therapy
24 September 2025
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uniQure (QURE) Stock Soars on Huntington’s Breakthrough – Key Facts & 2025 Outlook

uniQure (QURE) Stock Soars on Huntington’s Breakthrough – Key Facts & 2025 Outlook

Historic Huntington’s Results: On September 24, 2025, uniQure revealed landmark Phase I/II trial results for its Huntington’s disease gene therapy AMT-130. In patients treated with a one-time injection of AMT-130, disease progression was significantly slowed – by about 75% over three years for those on the high dose reuters.com. Treated patients maintained far more of their motor and cognitive function compared to the expected decline in Huntington’s, which is an invariably progressive and fatal neurodegenerative disorder reuters.com reuters.com. Crucially, there are currently no approved drugs that slow Huntington’s disease, so these results position AMT-130 as potentially the first disease-modifying therapy in this space reuters.com. “These groundbreaking data are the most convincing in the field to date and underscore potential disease-modifying effects in Huntington’s disease, where an urgent need persists,” said Dr. Sarah Tabrizi, director of UCL’s Huntington’s Disease Center, commenting on the trial outcome reuters.com. The gene therapy also appeared safe: no new serious side effects have emerged since 2022 in the study reuters.com, easing earlier safety concerns.
24 September 2025
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Stock Market Today

  • Arm Holdings posts 20% revenue jump, powered by Q4 licensing gains
    July 3, 2026, 12:05 PM EDT. Arm Holdings said Q4 revenue rose 20% from a year ago to $1.49 billion, as licensing and other revenue climbed 29% to $819 million. The company is seeing licensing drive growth with strong demand for its processor designs for AI, cloud and smartphones. Royalty revenue was up 11% to $671 million, as more customers adopt Armv9 and Arm Compute Subsystems. Unlike rivals NVIDIA and AMD, Arm collects both licensing fees and ongoing royalties, giving the company a mix of upfront and recurring revenue as AI and advanced computing markets grow.
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