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uniQure« Terug naar discussie overzicht

Wat is de waarde van uniQure?

7.806 Posts
Pagina: «« 1 ... 306 307 308 309 310 ... 391 »» | Laatste | Omlaag ↓
  1. Vitavita 7 januari 2018 16:47
    quote:

    Vitavita schreef op 7 januari 2018 16:46:

    quote:
    "Prof. Dollar schreef op 4 nov 2017 om 16:16: Interview met Sander van Deventer in BNR, vanaf pakweg minuut 25: www.bnr.nl/player/audio/10070425/1033... Dank aan @flosz

    Helaas pas in Q1 update over nieuwe programma's. Dat bleek ook al uit een eerdere presentatie van Jonathan Garen, die daarover nogal twijfelachtig overkwam: '[..] we intend to try to announce new targets and programs later this year'."

    Vitavita 5 nov 2017 om 16:34: "Aha, nieuws in het volgende kwartaal.
    Nieuws over producten in de pijplijn.....ik denk dat het nieuws niet beperkt zal blijven tot de huidige bekende pijplijnproducten als hartfalen en hemofilie B....

    Ik zie er naar uit.

    Sander is terug, en heeft er zin !

    Inmiddels is Q1-2018 aangebroken, ik zie uit naar de betreffende mededelingen.

  2. Fartknock 8 januari 2018 15:26
    tools.eurolandir.com/tools/Pressrelea...

    uniQure Provides Year-End 2017 Corporate Update and Outlines Near-Term Objectives to Further Drive Shareholder Value

    ~ Pivotal Trial in Hemophilia B on Track to Begin in Q3 2018, with Initial AMT-061 Clinical Data by Year End ~

    ~ AMT-130 Expected to be First AAV-Based Gene Therapy for Huntington's Disease to Enter Clinic ~

    ~ Strong Cash Position Sufficient to Fund Company into 2020 ~

    LEXINGTON, Mass. and AMSTERDAM, the Netherlands, Jan. 08, 2018 (GLOBE NEWSWIRE) -- uniQure N.V. (NASDAQ:QURE), a leader in human gene therapy, today announced its near-term objectives following a transformational year of achievement and corporate execution. Key business accomplishments during 2017 included uniQure's alignment with regulatory authorities to advance AMT-061 into late-stage clinical development in hemophilia B, progress with its research pipeline including AMT-130 in Huntington's disease, further enhancement of the Company's manufacturing capabilities, and the strengthening of its financial position.

    "We ended 2017 with significant momentum across all of our programs and the cash to fund operations into 2020," stated Matthew Kapusta, chief executive officer of uniQure. "Now that we have established robust, commercial-scale manufacturing in our Lexington facility, we are highly focused on the near-term initiation of our pivotal study of AMT-061 in hemophilia B and Phase I/II trial of AMT-130 in Huntington's disease."

    "We also are intensifying efforts to further expand our gene therapy product pipeline. In addition to AMT-126, our BMS-partnered gene therapy candidate for congestive heart failure, we have a number of promising early-stage projects focused on liver-directed and CNS disorders. We expect multiple new INDs to be filed over the next two years, further leveraging our industry-leading manufacturing and technology platform."

    uniQure management is meeting with investors and analysts this week in conjunction with the 36th Annual J.P. Morgan Healthcare Conference taking place in San Francisco. An updated corporate presentation has been posted to the investor page of the Company's website, www.uniqure.com.

    Key Near-Term Objectives

    Advance AMT-061 into pivotal study for hemophilia B - The Company intends to initiate a global, pivotal program for AMT-061 in hemophilia B during the third quarter of 2018. Top-line data from the initial patients are expected to be announced before the end of 2018. The Chemistry, Manufacturing and Controls (CMC) comparability protocol, which has been agreed upon with the FDA, is nearly complete and the data continues to support comparability between AMT-061 and AMT-060. An amendment to the existing Investigational New Drug (IND) application is expected to be submitted to the U.S. Food and Drug Administration (FDA) in the first quarter of 2018.

    Advance AMT-130 into Phase I/II study for Huntington's disease - The Company plans to complete its Good Laboratory Practices (GLP) toxicology study of AMT-130 in mid-2018 and file an IND application with the FDA in the second half of 2018. The Company expects to begin clinical development of AMT-130 soon after IND acceptance, with the goal of it being the first AAV-based gene therapy to begin human clinical evaluation.

    Advance AMT-126 towards IND filing for congestive heart failure - In early 2018, the Company and Bristol-Myers Squibb (BMS) expect to initiate a preclinical heart function study of AMT-126 in a diseased minipig model. Assuming positive results from this study, the Company expects BMS will initiate a GLP toxicology study to support the submission of an IND application and the initiation of a Phase I/II clinical study.

    Further expand product pipeline - In 2018, the Company expects to introduce new product candidates with a focus on liver-directed and central nervous system (CNS) disorders, areas in which the Company has established strong technology and manufacturing capabilities.

    Execute multiple manufacturing campaigns - During 2018, the Company will conduct large-scale manufacturing campaigns in its state-of-the-art manufacturing facility based in Lexington, MA for each of its key R&D programs. The Company expects to manufacture and release current Good Manufacturing Processes (cGMP) compliant material to be used in the AMT-061 pivotal program, the AMT-130 Phase I/II study and the AMT-126 GLP toxicology study.

    Financial Guidance

    As of December 31, 2017, the Company had approximately $159 million in cash and cash equivalents, and expects cash on hand will be sufficient to fund operations into 2020.

    Major Accomplishments Throughout 2017

    Hemophilia B - AMT-061

    Achieved alignment with the FDA and European Medicines Agency (EMA) on expedited clinical and regulatory pathway for AMT-061, a potential best-in-class gene therapy combining the Factor IX (FIX)-Padua gene with AAV5
    Demonstrated 6- to 7-fold greater FIX activity in non-human primates with AMT-061 compared to AMT-060
    Initiated commercial-scale, cGMP production of AMT-061 clinical batches
    Acquired patent family covering the use of FIX-Padua in gene therapy
    Achieved Breakthrough and PRIME designations from FDA and EMA

    Huntington's Disease - AMT-130

    Initiated and completed dosing of an IND-enabling, GLP safety study
    Successfully transferred manufacturing of AMT-130 to Lexington facility and initiated commercial-scale, cGMP production
    Presented preclinical data in one of the largest diseased animal models showing widespread distribution of AMT-130 in the brain and more than 50% knockdown of mutant huntingtin protein
    Achieved U.S. Orphan Drug Designation

    Congestive Heart Failure - AMT-126 (partnered with Bristol-Myers Squibb)

    Successfully demonstrated superior DNA delivery and S100A1 protein expression in a large animal model after administration of AMT-126
    Successfully transferred manufacturing of AMT-126 to Lexington facility and initiated cGMP production

    Manufacturing Capabilities

    Successfully produced multiple AAV5-based, gene therapy products at commercial-scale and under cGMP conditions using the same fundamental manufacturing process, controls and methods
    Key patents issued covering aspects of the manufacturing process critical to large-scale production of AAV-based gene therapies using an insect cell-based, baculovirus expression system

    Research on AAV5

    Presented clinical data demonstrating favorable immunogenicity profile of AAV5 and low prevalence of preexisting neutralizing antibodies
    Presented data demonstrating successful re-administration of AAV5 in non-human primates

    Corporate Developments

    Appointed new members of the leadership team and board of directors
    Re-acquired global rights to hemophilia B program
    Completed follow-on offering raising $91 million in gross proceeds
  4. T. Montana 8 januari 2018 23:57
    quote:

    cqtvld schreef op 8 januari 2018 23:18:

    Denk ik goed bericht ,zakt dit aandeel weer naar beneden,hoe is het mogelijk......
    Ik denk dat de optimistisch verwoorde "key near-term objectives" door de markt als te ver weg worden gezien. Bij gebrek aan werkelijke near term objectives mogen we blij zijn als we het jaar zijwaarts doormodderen. Ben er eens te meer van overtuigd dat 2019 het jaar wordt. Studies onderweg, nieuwe programma's aangekondigd en wie weet een mooie deal - Pfizer bijvoorbeeld. Pfizer heeft net hard gesneden in R&D-actviteiten, zijn niet bang om beslissingen te nemen. Zou zo maar kunnen dat ze het Spark Hem B program (lees neutralizing antibodies) en de IP rond de Padua-variant tegen het licht houden en het te licht bevinden en van paard wisselen. Dat zou leuk zijn. Een 2de opeenvolgend jaar 3X over de kop is niet reëel. Maar eind 2019 zouden we er zomaar kunnen staan. Ik heb geduld, zelfs tot daarna. Als AMT-126 de belofte inlost dan is de sky the limit. Tot die tijd gewoon blijven ademhalen.
  5. Vitavita 9 januari 2018 00:14
    quote:

    cqtvld schreef op 8 januari 2018 23:18:

    Denk ik goed bericht ,zakt dit aandeel weer naar beneden,hoe is het mogelijk......
    Een zuiver koersmanipulatie-dag.....gelet op de mooie berichtgeving, wordt geprobeerd met korting aandelen te verkrijgen, zie de aankopen in de laatste periode.
  6. Vitavita 9 januari 2018 00:22
    Persbericht: "Further expand product pipeline - In 2018, the Company expects to introduce new product candidates with a focus on liver-directed and central nervous system (CNS) disorders, areas in which the Company has established strong technology and manufacturing capabilities."

    Herhaaldelijk in H2-2017 door het management gemeld, en vandaag nogmaals bevestigd.....

    Ik verwacht dat de aanstaande berichtgeving onze harten sneller zal laten kloppen.
    Wellicht al in Q1-2018 met "introduce new product candidates with a focus on liver-directed and central nervous system (CNS) disorders".

    Exciting!!
  7. Prof. Dollar 9 januari 2018 19:28
    De relatie met BMY baart mij wel zorgen. Neem deze zinsnede: 'Assuming positive results from this study, the Company expects BMS will initiate a [..]. Het deel 'the Company expects' is zo voorzichtig en onzeker; eruit laten maakt de zin veel sterker. Toch hebben ze het er bewust ingezet, maar waarom? Daarbij zou de 'preclinical heart function study of AMT-126 in a diseased minipig model' eind vorig jaar al starten. Vanwaar het oponthoud?

    Verder is het bijzonder dat men in persberichten nimmer spreekt over het Hemofilie A programma. Het staat nota bene gewoon in de pipeline! Let op: straks kondigen ze dit aan als 'nieuw' programma; vergelijkbaar met AMT-061 als AMT-060. Ik versta onder nieuw ook écht nieuw: nieuwe (big) targets waarmee QURE denkt te winnen; de eerste en beste in de markt.

    Ook ik kijk reikhalzend uit naar de aankondiging van 'new product candidates with a focus on liver-directed and central nervous system (CNS) disorders'. Maar wel met die verstande dat men dat doet op een academische conferentie met overtuigende pre-klinische data. Ik verwacht dit pas op zijn vroegst halverwege het tweede kwartaal.
  15. Prof. Dollar 24 januari 2018 19:08
    Gewoon present! And still going strong and long.

    Toegegeven, het aandeel staat hoger dan ik eerder dit jaar had verwacht dat het zou staan. Het marktsentiment zit mee, laten we het daar op houden. Verder is er niet echt nieuws dat tot de verbeelding spreekt of tot speculatie schrijft. Ik blijf uitkijken naar de eerste aanwijzingen over nieuwe programma's.
  18. Fartknock 1 februari 2018 13:35
    tools.eurolandir.com/tools/Pressrelea...

    uniQure to Participate in Multiple Conferences in February

    LEXINGTON, Mass. and AMSTERDAM, the Netherlands, Feb. 01, 2018 (GLOBE NEWSWIRE) -- uniQure N.V. (NASDAQ:QURE), a leader in human gene therapy, today announced that members of company management or principal investigators will participate in upcoming business, medical and investor conferences during February.
    •Bentley University Innovator's Business Series, February 6, 2018 at Bentley University in Waltham, Massachusetts.

    o Matthew Kapusta, chief executive officer of uniQure, will be the keynote speaker for a presentation entitled, "Delivering on the Promise of Gene Therapy" on Tuesday, February 6, 2018 at 5:00 p.m. EST.
    •SunTrust 4th Annual Orphan Drug Day, February 13, 2018 at the JW Marriott Essex House in New York City

    o Company management will be hosting meetings with institutional investors throughout the day.
    •Leerink Partners 7th Annual Global Healthcare Conference, February 14 - 15, 2018 at the Lotte New York Palace Hotel in New York City

    o Mr. Kapusta will be participating in a Fireside Chat on Wednesday February 14, at 9:00 a.m. EST. The live webcast can be accessed by the link displayed in the Investor section of the uniQure website. The webcast replay will be available for at least 72 hours following the live event.
    •13th Annual Huntington's Disease Therapeutics Conference, February 26 - March 1, 2018 at the Parker Hotel in Palm Springs, California

    o Investigators at the Centre for Molecular Medicine and Therapeutics & BC Children's Hospital Research Institute, University of British Columbia, Vancouver, Canada, will present novel, preclinical data on uniQure's proprietary investigational gene therapy, AMT-130, in humanized mice models of Huntington's disease. The presentation is expected to include data demonstrating non-selective silencing of mutant HTT and improvements in select behavioral and neuropathological Huntington's disease phenotypes.
7.806 Posts
Pagina: «« 1 ... 306 307 308 309 310 ... 391 »» | Laatste |Omhoog ↑

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