14 stories mentioning QUREUpdated 27d ago
Every FINWIRES story that references QURE, newest first.
Jack Kaye, Director, on June 30, 2026, sold 21,167 shares in Uniqure (QURE) for $983,030. Following the Form 4 filing with the SEC, Kaye has control over a total of 25,996 ordinary shares of the company, with 25,996 shares held directly.SEC Filing:https://www.sec.gov/Archives/edgar/data/1590560/000090445426000392/xslF345X05/edgar.xml
Matthew C Kapusta, Director, Chief Executive Officer, Managing Director, on June 17, 2026, sold 206,100 shares in Uniqure N.v. (QURE) for $9,371,612. Following the Form 4 filing with the SEC, Kapusta has control over a total of 521,795 ordinary shares of the company, with 521,795 shares held directly.SEC Filing:https://www.sec.gov/Archives/edgar/data/1590560/000090445426000372/xslF345X05/edgar.xml
Madhavan Balachandran, Director, on June 17, 2026, sold 11,685 shares in Uniqure N.v. (QURE) for $526,485. Following the Form 4 filing with the SEC, Balachandran has control over a total of 43,254 ordinary shares of the company, with 43,254 shares held directly.SEC Filing:https://www.sec.gov/Archives/edgar/data/1590560/000090445426000370/xslF345X05/edgar.xml
UniQure (QURE) has a clearer path toward possible accelerated approval of its investigational drug for Huntington's disease after the US Food and Drug Administration signaled it is open to accepting a biologics license application based on three-year data, RBC Capital Markets said in a note Wednesday.The investment firm said the regulator will likely accept a BLA with priority review when the company files it in Q3 because of the unmet need.The FDA's willingness to consider the filing without waiting for four-year data and placebo-controlled trial signals regulatory leniency that is also "great news" for the broader industry and improves the outlook for the drug, according to the note.Analysts said they now estimate a 75% chance of approval, compared with 50% previously, although the company still needs to reach alignment with the FDA on the confirmatory trial details prior to BLA submission.RBC has an outperform, speculative risk rating on the stock, with a price target raised to $65 from $35.Shares of uniQure were down more than 2% in Thursday trading.Price: $46.91, Change: $-1.25, Percent Change: -2.60%
Healthcare stocks declined late Wednesday afternoon, with the NYSE Healthcare Index falling 1.3% and the State Street Health Care Select Sector SPDR ETF (XLV) shedding 1.8%.The iShares Biotechnology ETF (IBB) rose 0.7%.In corporate news, ResMed (RMD) shares fell 4.5% after Morgan Stanley downgraded the company to equalweight from overweight and cut its price target to $230 from $286.UniQure (QURE) shares surged 76% after the company said that it intends to submit a Biologics License Application for the accelerated approval of AMT-130 to treat Huntington's disease in Q3.Novo Nordisk (NVO) said it is aware of claims by cyber extortion group FulcrumSec that it stole company data and sought a $25 million payment, Reuters reported. Novo shares were up 0.2%.Moderna (MRNA) plans to invest in production sites in Germany and is interested in the plants that BioNTech (BNTX) has slated for closure, according to a Google translation of a Wednesday report from German news outlet Handelsblatt. Moderna shares jumped almost 11%, and BioNTech was up 2.3%.
(Updates with recent stock movement in headline and first paragraph.)UniQure (QURE) shares surged 79% in afternoon trading on Wednesday after the company said that it intends to submit a Biologics License Application for the accelerated approval of AMT-130 to treat Huntington's disease in Q3.uniQure said the decision was made after a meeting with the US Food and Drug Administration, during which the regulator said that its three-year analysis from a phase 1/2 study would be acceptable as the primary basis of the application.The FDA also seeks to align with the company on the confirmatory study design before the application is submitted, including consideration of a standard care control group rather than a sham procedure."The consistency and strength of the clinical data generated to date give us great confidence in the product's potential to make a meaningful difference for patients," Chief Executive Matt Kapusta said in a statement.The company expects to receive the final minutes within 30 days of the meeting.Price: $48.35, Change: $+21.36, Percent Change: +79.14%
AstroNova (ALOT) 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 (QURE) 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 (LZB) 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%
Healthcare stocks were mixed premarket Wednesday, with the State Street Health Care Select Sector SPDR ETF (XLV) down 0.1% and the iShares Biotechnology ETF (IBB) 0.1% higher.Novo Nordisk (NVO) said it is aware of claims by cyber extortion group FulcrumSec that it stole company data and sought a $25 million payment, Reuters reported. Shares of Novo Nordisk were up more than 3% pre-bell.uniQure (QURE) stock was up more than 66% after the company said it intends to submit a Biologics License Application for the accelerated approval of AMT-130 to treat Huntington's disease in Q3.Jazz Pharmaceuticals (JAZZ) and AbCellera Biologics (ABCL) signed a preclinical research collaboration, option and license deal to discover and develop T-cell engaging multispecific antibodies, the companies said. Shares of AbCellera Biologics were up more than 2% and Jazz Pharmaceuticals stock was over 1% higher premarket.
Walid Abi-Saab, Chief Medical Officer, on May 08, 2026, sold 45,000 shares in Uniqure (QURE) for $1,127,500. Following the Form 4 filing with the SEC, Abi-Saab has control over a total of 169,669 ordinary shares of the company, with 169,669 shares held directly.SEC Filing:https://www.sec.gov/Archives/edgar/data/1590560/000090445426000260/xslF345X05/edgar.xml
UniQure (QURE) shares fell 1.8% in early Tuesday trading after the company posted a wider Q1 loss.The company reported a Q1 loss Tuesday of $0.85 per diluted share, widening from a loss of $0.82 a year earlier.Analysts surveyed by FactSet expected a loss of $0.85.Revenue for the quarter ended March 31 was $3.6 million, up from $1.6 million a year earlier.Analysts polled by FactSet expected $5.2 million.Price: $20.30, Change: $-0.38, Percent Change: -1.84%
Health care stocks rose late Thursday afternoon with the NYSE Health Care Index climbing 2.6% and the State Street Health Care Select Sector SPDR ETF (XLV) adding 2.3%.The iShares Biotechnology ETF (IBB) advanced 1.9%.In corporate news, UniQure (QURE) shares jumped past 16% after the company said it plans to submit a UK marketing authorization application in Q3 for AMT-130 to treat Huntington's disease.Axsome Therapeutics (AXSM) shares surged 12% after it said the US Food and Drug Administration approved Auvelity to treat agitation associated with Alzheimer's disease dementia.Eli Lilly (LLY) raised its full-year outlook and reported Q1 results above market estimates as sales of Mounjaro more than doubled. Lilly shares jumped past 10%.The US Food and Drug Administration is proposing to exclude tirzepatide, semaglutide and liraglutide from the 503B bulks list, finding no clinical need for outsourcing facilities to compound the drugs from bulk substances. Eli Lilly makes tirzepatide, marketed as Mounjaro for type 2 diabetes and Zepbound for chronic weight management. Novo Nordisk (NVO) makes semaglutide, marketed as Ozempic for type 2 diabetes and Wegovy for chronic weight management, and liraglutide, under the brand name Victoza for type 2 diabetes and Saxenda for chronic weight management. Novo shares rose past 5%.
Health care stocks rose late Thursday afternoon with the NYSE Health Care Index climbing 2.6% and the State Street Health Care Select Sector SPDR ETF (XLV) adding 2.3%.The iShares Biotechnology ETF (IBB) advanced 1.9%.In corporate news, UniQure (QURE) shares jumped past 16% after the company said it plans to submit a UK marketing authorization application in Q3 for AMT-130 to treat Huntington's disease.
(Updates with the latest stock move in the headline and in the first paragraph.)UniQure (QURE) shares were up over 18% in Thursday trading after the company said it plans to submit a UK marketing authorization application in Q3 for AMT-130 for the treatment of Huntington's disease.The plan came after a pre-submission meeting with the UK's Medicines and Healthcare products Regulatory Agency, it said.The company said it has also been granted a Type B meeting with the US Food and Drug Administration in Q2, and expects to discuss key elements of a potential phase III trial design.The company said it is pursuing additional regulatory pathways in international markets for the potential registration of AMT-130 and expects to provide further updates in H2.Price: $19.82, Change: $+3.09, Percent Change: +18.47%
UniQure (QURE) said Thursday it plans to submit a UK marketing authorization application in Q3 for AMT-130 for the treatment of Huntington's disease.The decision to submit was made after a pre-submission meeting with the UK's Medicines and Healthcare products Regulatory Agency, the company said.The company said it has also been granted a Type B meeting with the US Food and Drug Administration in Q2, and expects to discuss key elements of a potential phase III trial design and to receive feedback on analysis plan in Q3.The company is actively pursuing additional regulatory pathways in international markets for the potential registration of AMT-130 and expects to provide further updates in H2, it said.Price: $19.02, Change: $+2.29, Percent Change: +13.66%
