uniQure N.V.
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No SEC Form 4 filings for $QURE in the last 30 days.
See all $QURE insider activity →Replimune (REPL) and uniQure (QURE) shares rose 7% and 5% respectively after FDA Commissioner Marty Makary resigned. Makary's departure followed clashes with the Trump administration over e-cigarette authorizations. The FDA previously rejected REPL's melanoma therapy and changed feedback on QURE's Huntington's disease treatment.
uniQure (QURE) submitted a biologics license application for accelerated approval of ifezuntirgene inilparvovec for Huntington's disease, requesting priority review. The application relies on Phase I/II data compared with external controls. The FDA must decide whether to accept the application and if the evidence supports approval.
uniQure has applied to the FDA and UK's MHRA for accelerated approval of AMT-130, a gene therapy for Huntington's disease. The therapy aims to slow disease progression by 75% according to clinical trial data. FDA priority review could shorten the review time to six months.
Over the past 7 days, AlphAI's AI scored 3 news stories mentioning QURE (uniQure N.V.). Coverage has skewed bullish: 2 bullish, 1 neutral, and 0 bearish.
Recent QURE coverage spans regulation and market movers.
Positive short-term price move linked to FDA commissioner turnover.
Positive regulatory milestone may lift the stock if FDA accepts the filing.
Potential approval could unlock significant upside for the biotech, while a denial would pressure the stock.
uniQure submitted a Biologics License Application to the FDA for accelerated approval of its gene therapy AMT-130 for Huntington's disease, with a parallel application to the UK regulator. The therapy, if approved, would be delivered via neurosurgery at specialized centers. The application is based on a Phase 1/2 study with an external control group, and the FDA has not yet decided on priority review.
Potential accelerated approval could lift regulatory risk and drive significant upside.
AlphAI scores every news story that mentions QURE with an AI model for sentiment and relevance, and aggregates insider trades from uniQure N.V.'s SEC EDGAR Form 4 filings. Figures refresh continuously.
Replimune (REPL) and uniQure (QURE) shares rose 7% and 5% respectively after FDA Commissioner Marty Makary resigned. Makary's departure followed clashes with the Trump administration over e-cigarette authorizations. The FDA previously rejected REPL's melanoma therapy and changed feedback on QURE's Huntington's disease treatment.
2 min readuniQure (QURE) submitted a biologics license application for accelerated approval of ifezuntirgene inilparvovec for Huntington's disease, requesting priority review. The application relies on Phase I/II data compared with external controls. The FDA must decide whether to accept the application and if the evidence supports approval.
2 min readuniQure has applied to the FDA and UK's MHRA for accelerated approval of AMT-130, a gene therapy for Huntington's disease. The therapy aims to slow disease progression by 75% according to clinical trial data. FDA priority review could shorten the review time to six months.
2 min readuniQure submitted a Biologics License Application to the FDA for accelerated approval of its gene therapy AMT-130 for Huntington's disease, with a parallel application to the UK regulator. The therapy, if approved, would be delivered via neurosurgery at specialized centers. The application is based on a Phase 1/2 study with an external control group, and the FDA has not yet decided on priority review.
2 min readuniQure (QURE) filed for U.S. and U.K. approval of its Huntington’s disease gene therapy, AMT-130. William Blair resumed coverage with an Outperform rating and $73 price target, citing a 58% upside. Shares initially rose 6% but closed down 3%. The FDA may grant priority review, potentially cutting the review period. AMT-130, if approved, would be uniQure’s second marketed gene therapy.
2 min readuniQure (QURE) filed for accelerated approval of its gene therapy AMT-130 for Huntington's disease with the FDA and MHRA. The submissions are backed by three-year Phase 1/2 study data. William Blair resumed coverage with an Outperform rating and $73 target, citing regulatory progress and potential $3.2B peak sales by 2035. QURE shares fell 4.95% on Wednesday.
1 min readUniQure's (QURE) stock declined after the FDA accepted its application for a Huntington's gene therapy, resolving a dispute over study requirements. The therapy is now closer to approval.
2 min readUniqure NV (QURE) stock rose 2.4% in pre-market trading after William Blair initiated coverage with an 'Outperform' rating. The company has 11 buy-equivalent ratings and no sell recommendations. QURE's stock has increased 175% over the past year, driven by FDA alignment on its AMT-130 gene therapy for Huntington’s disease and a strong cash position.
1 min readUniQure (QURE) submitted a Biologics License Application to the FDA for AMT-130, a gene therapy for Huntington's disease, seeking accelerated approval. The submission is supported by three-year data showing slowed disease progression. The company also filed a similar application with the U.K.'s MHRA. QURE stock is up 6.04% in pre-market trading.
2 min readPresident Trump may fire FDA Commissioner Marty Makary, according to the Wall Street Journal. Several biotech and pharmaceutical companies, including Replimune (REPL), uniQure (QURE), Moderna (MRNA), and others, have publicly clashed with the FDA over drug-review processes. Shares of REPL, QURE, and MRNA rose 17%, 15%, and 10% respectively at the time of writing.
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