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uniQure Terug naar discussie overzicht

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  3. forum rang 10 DeZwarteRidder 12 augustus 2014 09:13

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    quote:

    Govindarajan schreef op 12 augustus 2014 07:47:

    Aug 11, 2014

    uniQure Acquires Cardiology Gene Therapy Company InoCard

    www.uniqure.com/news/205/182/uniQure-...
    Na deze overname hebben ze nog veeel meer geld nodig; de volgende emissie dus binnen 1 jaar....!!??

    En hoe gaan ze die lening van 20 miljoen aflossen....???
  4. QLVT 12 augustus 2014 09:46

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    OCH zeurpiet ook weer aanwezig of heeft ie misschien toch gelijk ...
  5. [verwijderd] 12 augustus 2014 09:58

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    Niemand heeft de wijsheid in pacht om te weten wat er precies gaat gebeuren. Wat ik wel weet is dat ik mijn schaapjes al ruimschoots op het droge heb. Alles extra is mooi meegenomen.
  6. Rosj Hasjana 12 augustus 2014 11:56

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    Geachte heer Midden,

    Hartelijk dank voor uw e-mail. U heeft een vraag over de status van de omwisseling van de UniQure aandelen naar de Amerikaanse notering op de Nasdaq beurs.

    Het proces is reeds in volle gang, maar Alex is helaas nog in afwachting op de stukken via onze buitenlandse broker in Amerika. Het betreft een compleet nieuwe notering en dit neemt een periode in beslag. Indien de stukken gedeponeerd zijn, berichten wij u per e-mail.



    Ik vertrouw erop u met deze informatie van dienst te zijn.

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  9. forum rang 10 DeZwarteRidder 2 september 2014 12:15

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    Financial Highlights

    As of June 30, 2014, the Company held cash and cash equivalents of EURO72.1 million. The numbers for the six months ended June 30, 2013 as presented below, have been restated; for further information please see the financial statements appearing at the end of this release.

    Licensing and collaboration revenues for the three months ended June 30, 2014 were EURO1.0 million, compared with EURO0.8 million in the same period of 2013. For the six months ended June 30, 2014, total revenue was EURO2.2 million, compared to EURO0.8 million in the first six months in 2013. Collaboration revenues represent development activities that are reimbursable by Chiesi under the Company's co-development agreement for hemophilia B. License revenues represent the monthly amortization of the upfront payments received under the Chiesi agreements entered into in June 2013.

    Research and development expenses were EURO8.0 million for the three months ended June 30, 2014, compared to a restated EURO2.9 million for the same period in 2013. Research and development expenses for the six months ended June 30, 2014 are EURO14.2 million compared to EURO6.4 million for the same period in 2013. The increase reflected the expansion of research and development activities to support the further development of the hemophilia B program, the further development of other pipeline product candidates, as well as the company's efforts to maintain its leadership position in the gene therapy field. The amount of research and development expenses is shown net of charges that were capitalized in relation to the development of the Company's approved product, Glybera.

    Net loss for the three months ended June 30, 2014 was EURO9.0 million or EURO0.51 per share, compared to EURO7.8 million or EURO0.80 per share for the same period in 2013. Net loss for the six months ended June 30, 2014 was EURO16.8 million or EURO1.03 per share, compared to EURO13.0 million or EURO1.33 per share for the same period in 2013.

    In the three months ended June 30, 2014 the Company signed an amended and restated loan agreement with Hercules Technology Growth Capital Inc. to increase its existing venture debt facility to $20.0 million (EURO14.6 million) and in May 2014 the Company rolled out the 2014 Option Plan granting a total of 926,000 options to staff and affiliates, with an exercise price of $9.35.

    For further financial information for the period ending June 30, 2014, please refer to the financial statements appearing at the end of this release.
  10. [verwijderd] 2 september 2014 12:30

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    Vergeet de rest niet...

    AMSTERDAM, the Netherlands, Sept. 2, 2014 (GLOBE NEWSWIRE) -- uniQure N.V. (Nasdaq:QURE), a leader in human gene therapy, today announced results for the second quarter of 2014 and an update on multiple gene therapy programs.

    Corporate Highlights

    • In July, uniQure announced the acquisition of InoCard GmbH, an innovative, early-stage biotechnology company focused on the development of gene therapy approaches for cardiac disease. InoCard has developed a novel gene therapy to preclinical proof of concept, for the one-time treatment of congestive heart failure (CHF), a rapidly progressing disease affecting 26 million people worldwide. InoCard founders Prof. Patrick Most and Prof. Hugo Katus will join uniQure as Managing Director of uniQure in Germany and Chairman of the Scientific Advisory Board for Cardiovascular Diseases, respectively.
    • uniQure closed an additional $10 million venture debt loan with Hercules Technology Growth Capital, Inc., increasing the total loan amount to $20 million and providing the Company with greater balance sheet strength and flexibility. The additional capital will be devoted both to rapidly advancing uniQure's pipeline and to accessing early-stage opportunities that will enable the Company to leverage its gene therapy platform and manufacturing expertise. As of June 30, 2014, the Company held cash and cash equivalents of €72.1 million.
    • Construction has been completed on the Lexington, Massachusetts facility and employees have moved in after an occupancy certificate was received for the GMP rooms in June 2014. The facility is expected to be fully operational in the first half of 2015.
    • Will Lewis, MBA/JD, joined uniQure's Supervisory Board. Mr. Lewis is President and Chief Executive Officer of NASDAQ listed Insmed Inc. and brings to uniQure more than 20 years of executive experience in the pharmaceutical and finance industries as well as in the field of orphan diseases.

    Pipeline Program Updates

    • Hemophilia B Program - The Company remains on target for the initiation of a Phase 1/2 clinical trial for the hemophilia B AAV5 candidate late in the second half of 2014. Manufacturing of clinical material is currently being completed to enable release as planned in Q4 2014. uniQure has submitted the necessary documentation for the clinical trial application to the authorities in Germany.
    • Collaborator-sponsored Pipeline Programs - The current clinical trials being conducted in the Sanfilippo B program with Institut Pasteur and the Acute Intermittent Porphyria program with University of Navarra are fully enrolled and on track for 2014 (AIP) and 2015 (Sanfilippo B) data release. In the partnership with UCSF and NIH for Parkinson's disease five of the six patients in the first dose cohort have been dosed.
    • AAV5 Vector Validation - In May, uniQure successfully documented the potential clinical utility of its proprietary AAV5 vector for liver-directed gene therapy. Results obtained from an ongoing Acute Intermittent Porphyria (AIP) dose-escalation Phase 1 trial provided safety evidence for the AAV5 vector from the baculovirus production platform by successfully delivering DNA to the liver in AIP patients without liver enzyme perturbations.
    • 4D Molecular Therapeutics Collaboration - In the research program with 4D Molecular Therapeutics, under which uniQure gained exclusive access to 4D's AAV vector discovery and optimization technology for gene delivery to the central nervous system and liver, the Company expects to make a preliminary selection of new synthetic vectors in the first half of 2015.

    Glybera Updates

    • European Launch - In early August uniQure and its commercialization partner Chiesi provided an update on preparations relating to the launch of Glybera® (alipogen tiparvovec) in the European Union for the treatment of the orphan disease lipoprotein lipase deficiency (LPLD). Chiesi has exclusive rights to commercialize Glybera in the EU and selected additional territories. Chiesi and uniQure decided to include the six-year follow-up pancreatitis data from the study AMT 011-05, in the pricing and reimbursement applications as announced on June 3, 2014. Chiesi now expects to launch Glybera in the fourth quarter of 2014/first quarter of 2015.
    • Six-year Follow-up Data - uniQure announced the analysis of six-year follow-up data from the study AMT 011-05 for Glybera for the treatment of LPLD, which validate long-term clinical benefits. Following Glybera treatment LPLD patients no longer experienced severe pancreatitis, and the occurrence of less severe events was reduced by approximately 50%.
    • U.S. Regulatory Progress - To optimize the time for patients in the US to access Glybera and make the overall process more efficient, uniQure intends to combine both EMA and FDA requirements into one clinical protocol for the Phase 4 study. As a result, the Company expects a delay in generating the clinical data to support the filing in the US. This delay is in part the result of longer than expected EMA approval timelines due to required changes in the protocol in support of the US filing strategy, resulting in a planned Phase 4 trial start mid 2015, and in part the result of limited product supply due to a Glybera-specific batch release assay being out of specification.
    • Manufacturing Ramp-up - uniQure continues to optimize its original Glybera-specific manufacturing process to match the higher manufacturing standards already achieved with later pipeline products (e.g. Acute Intermittent Porphyria, Sanfilippo, Hemophilia) and to increase Glybera-specific batch release success rates. The Company expects to be able to meet 2015 EU commercial demand for Chiesi with current stock and from future production runs commencing later in 2014, assuming higher manufacturing standards are successfully implemented.
    • New Distribution Alliance - uniQure signed an exclusive distribution agreement with Medison Pharma Ltd., Israel's leading pharmaceutical marketing group. Under the terms of the agreement, Medison will market Glybera in Israel and the Palestinian Authority territories. uniQure continues to negotiate similar marketing agreements for Glybera in those regions where the Company plans to market the product with a commercialization partner.

    Jörn Aldag, uniQure Chief Executive Officer, commented: "uniQure is steadily executing its strategy of building a valuable clinical and pre-clinical pipeline from its gene therapy platform. We made major progress toward the achievement of preclinical, clinical, and corporate development goals, which we view to be essential to maintain our position at the forefront of gene therapy. In the second half of the year, we are focused on the start of the hemophilia B clinical trial."
  11. flosz 10 november 2014 16:27

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    uniQure to Present at Jefferies Global Healthcare Conference - London

    Nov 10, 2014

    Amsterdam, the Netherlands, November 10, 2014 — uniQure N.V. (Nasdaq: QURE), a leader in human gene therapy, today announced that Jörn Aldag, CEO, will present a corporate overview at Jefferies Global Healthcare Conference – London, to be held November 19-20, 2014.

    Mr. Aldag’s presentation will take place November 19, 10:40-11:20 a.m. (GMT).

    To access a simultaneous webcast of Mr. Aldag's presentation via the internet, log on to the “Events” section on the Media page of the uniQure website at www.uniqure.com/news/calendar-of-events/

    A replay of the webcast will be available from uniQure’s website for 30 days following the conference. Mr. Aldag’s presentation will be available for download in PDF format immediately following the conference presentation in the "Events" section of the Media page of uniQure's website at www.uniqure.com/news/calendar-of-events/
    www.uniqure.com/news/219/182/uniQure-...

  12. stylo 13 november 2014 22:45

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    Benelux biotech sector attracts strong interest from top segment of US investors

    On November 13, 2014, KBC Securities, supported by FlandersBio and Flanders Investment & Trade, will host the third edition of its Annual Benelux Biotech & Healthcare Conference in New York. The conference offers a unique opportunity to meet with top executives of 14 listed companies and 1 pre-IPO company, providing an excellent overview of the vibrant Benelux Life Sciences landscape. This conference is one of several initiatives of KBC Securities and underlines the firm’s continued support for the sector.
    ....

    Grote interesse voor Benelux biotech sector in New York

    Woensdag 12 november, 2014 — Op 13 november 2014 organiseert KBC Securities in samenwerking met FlandersBio en Flanders Investment & Trade de derde editie van de Annual Benelux Biotech & Healthcare Conference in New York. De conferentie biedt investeerders de mogelijkheid om meetings te beleggen met het top management van 14 genoteerde ondernemingen en 1 privaat (pre-IPO) bedrijf. Op deze manier geeft de conferentie investeerders een uniek overzicht van de levendige Benelux Life Science sector. De conferentie is een van de initiatieven die KBC Securities organiseert om de Life Science sector te ondersteunen.

    The Event is now firmly on the map of specialized Healthcare investors in New York and beyond
    ...

    Companies joining the 2014 event are Ablynx, arGEN-X, Arseus, Cardio3 Biosciences, Galapagos, Genticel, IBA, MDxHealth, Pharming, Promethera, Prosensa, ThromboGenics, Tigenix, UCB and Uniqure. - See more at: beursig.nl/forum/viewtopic.php?f=4&am...
  13. [verwijderd] 21 november 2014 15:42

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    Amsterdam, The Netherlands, Nov. 21, 2014 (GLOBE NEWSWIRE) -- uniQure N.V. (Nasdaq:QURE), a leader in human gene therapy, today announced that it will be hosting an Investor Day and simultaneous webcast in New York City on December 1, 2014, starting at 8:30 a.m. uniQure management will be joined by distinguished guests to discuss the Company's strategy, clinical programs and uniQure's vision of how gene therapy will change the future of medicine.

    Event
    Date: December 1, 2014
    Time: 8:30 a.m. - approx. 12:30 p.m. ET
    Venue: InterContinental New York Times Square, 300 W. 44th St., New York City, NY

    Speakers

    • Jörn Aldag, Chief Executive Officer, uniQure
    • Krystof Bankiewicz, M.D., Ph.D., Professor of Neurosurgery and Neurology, University of California, San Francisco
    • Eric Goossens, Chief Operating Officer, uniQure
    • Ricki Lewis, Ph.D., Author and Genetics Expert
    • Wolfgang Miesbach, M.D., Head, Hemophilia Center, Johann Wolfgang Goethe University Hospital, Frankfurt/Main
    • Patrick Most, M.D., Professor of Molecular and Translational Cardiology, University of Heidelberg
    • Harald Petry, Ph.D., Chief Scientific Officer, uniQure
    • Hans Christian Rohde, Chief Commercial Officer, uniQure
    • David Schaffer, Ph.D., Professor of Chemical and Biomolecular Engineering, University of California, Berkeley

    Webcast
    To access the webcast, log on to www.media-server.com/m/p/tfx7rb2k or go to the "Events" section on the "Media" page of uniQure's website, at www.uniqure.com/news/calendar-of-events. A replay of the webcast will be available on uniQure's website for at least 30 days following the event.
  17. [verwijderd] 6 februari 2015 15:27

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    finance.yahoo.com/news/uniqure-presen...

    Fri, Feb 6, 2015, 9:26AM EST - US Markets open in 4 mins

    uniQure to Present at the at the Leerink Partners Global Healthcare Conference
    uniQure 3 hours ago GlobeNewswire

    AMSTERDAM, the Netherlands, Feb. 6, 2015 (GLOBE NEWSWIRE) -- uniQure to Present at the at the Leerink Partners Global Healthcare Conference

    Amsterdam, the Netherlands, February 6, 2015 - uniQure N.V. (QURE), a leader in human gene therapy, today announced that its management will present a corporate overview at the 2015 Leerink Partners Global Healthcare Conference February 11-12, 2015, to be held at the Waldorf Astoria New York, New York City, NY, USA.

    Date: February 12, 2015
    Time: 11:35 a.m. (ET)
    Location: Waldorf Astoria New York, New York City, NY, USA
    Speaking for uniQure: Joern Aldag, Chief Executive Officer

    To access a simultaneous webcast of Mr. Aldag's presentation via the internet, log on to the "Events" section on the Media page of the uniQure website at www.uniqure.com/news/calendar-of-even...

    A replay of the webcast will be available from uniQure's website for 30 days following the conference. Mr. Aldag's presentation will be available for download in PDF format immediately following the conference presentation in the "Events" section of the Media page of uniQure's website at www.uniqure.com/news/calendar-of-even...

    About uniQure
    uniQure is delivering on the promise of gene therapy through single treatments with potentially curative results. We have developed a modular platform to rapidly bring new disease-modifying therapies to patients with severe disorders. We are engaged in multiple partnerships and have obtained regulatory approval of our lead product, Glybera, in the European Union for a subset of patients with LPLD.

    uniQure:
    Aicha Diba
    Investor Relations
    Direct : +31 20 240 6100
    Main: +31 20 240 6000
    a.diba@uniQure.com

    Media inquiries:
    Gretchen Schweitzer
    MacDougall Biomedical Communications
    Direct: +49 172 861 8540
    Main: +49 89 2424 3494 or 1 781 235 3060
    gschweitzer@macbiocom.com

    HUG#1892448

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  18. pommeraie 6 april 2015 10:17

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    Webcast

    zie website Uniqure.com /investors /shareholder information /onder stock quote !!

    WEBCAST
    6 April 2015

    Year-End Results and Corporate Update
    Monday, April 6, 2015, 8:30 am EDT

    Click here to view webcast
  19. [verwijderd] 16 juli 2015 15:10

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    het QURE-team wordt versterkt...klinkt bemoedigend.

    finance.yahoo.com/news/dr-charles-w-r...

    Dr. Charles W. Richard Joins uniQure as Senior Vice President to Lead Development of CNS-focused Gene Therapy Pipeline
    --30 Year Veteran Brings Clinical, Genetics and Drug Development Expertise--
    uniQure
    3 hours ago
    GlobeNewswire

    ????

    AMSTERDAM, the Netherlands, July 16, 2015 (GLOBE NEWSWIRE) -- uniQure N.V. (QURE), a leader in human gene therapy, today announced that Charles W. Richard, M.D., Ph.D., has been hired as Senior Vice President, Research and Development, Neuroscience, to lead the Company's growing portfolio of gene therapies targeting neurological diseases including current clinical trials for the treatment of Sanfilippo B syndrome and Parkinson's disease as well as preclinical programs in Huntington's disease and other rare CNS disorders. Dr. Richard will report to Jorn Aldag, Chief Executive Officer of uniQure, and be based in the Company's Lexington, Massachusetts facility.

    Dr. Richard joins uniQure with 30 years of industry, academic and medical practice experience with a focus on rare and orphan diseases and the translation of emerging genetic technologies into drug development. Dr Richard most recently served as Chief Medical Officer of Oxyrane, a biotechnology company focused on developing second-generation enzyme replacement therapies for rare lysosomal storage diseases, where he remains a member of the Board of Directors. Previously, Dr. Richard led the Translational Medicine group at Shire Human Genetic Therapies, in the role of Principal Medical Director and Head of Translational Medicine, Clinical R&D. There he was responsible for the clinical development of novel enzyme replacement therapies for rare and orphan diseases including Sanfilippo A syndrome and Hunter Syndrome, among others. Prior to Shire, Dr. Richard held multiple roles at Wyeth, including Vice President and Head of the Department of Genomics at Wyeth Discovery Research where he established and led a team of 135 scientists providing core functions in bioinformatics, genetically-modified animal models, gene expression profiling, molecular medicine and pharmacogenomics, functional genomics and genomics core sciences. Before moving into industry, Dr. Richard was an Assistant Professor of Psychiatry and Human Genetics at the University of Pittsburgh Medical Center and before that position had completed nearly 10 years of medical practice and academic research. He received a Ph.D. in Pharmacology and an M.D., both from the Ohio State University School of Medicine, and a B.S. in Biology from Stanford University.

    "I am very pleased to welcome Charlie to the uniQure family. His broad experience in leading successful discovery and development efforts for novel medicines targeting neurological disorders will be extremely valuable to uniQure as we transition to a patient- and disease-focused organization," said Mr. Aldag. "With his deep understanding of genomics and neuroscience, and his strong knowledge of rare and orphan indications, Charlie will provide valuable insights as we advance and build our gene therapy product pipeline targeting serious CNS diseases."

    "This is a very exciting time to be joining uniQure. The Company's vision of building a gene therapy pipeline focused on neurological disorders, leveraging its established technology platform, offers a very exciting opportunity. During my career, I have been passionately focused on discovering and developing medical breakthroughs targeting underserved therapeutic indications, and I very much look forward to joining the uniQure leadership team as we deliver on the promise of gene therapy for patients suffering from neurological disorders," added Dr. Richard.

    In connection with Dr. Richard's offer of employment, uniQure approved non-statutory stock options to purchase 200,000 ordinary shares to Dr. Richard. The awards were made pursuant to the NASDAQ inducement grant exception as a component of Dr. Richard's employment compensation. The inducement grants were previously approved by uniQure's Remuneration Committee and are being made as an inducement material to Dr. Richard's acceptance of employment with the Company in accordance with NASDAQ listing Rule 5635(c)(4).

    The stock option awards have an exercise price of $27.82 per ordinary share, the closing price of uniQure's common stock on July 13, 2015. The stock options issued each have a 10-year term and vest over four years, with 25% of the original number of ordinary shares vesting on the first anniversary of Dr. Richard's hire date and an additional 6.25% of the original number or ordinary shares vesting at the end of each subsequent three-month period thereafter, subject to Dr. Richard's continued service with the Company through the applicable vesting dates.

    About uniQure

    uniQure is delivering on the promise of gene therapy through single treatments with potentially curative results. We have developed a modular platform to rapidly bring new disease-modifying therapies to patients with severe disorders. We are engaged in multiple partnerships and have obtained regulatory approval of our lead product, Glybera, in the European Union for a subset of patients with LPLD. www.uniQure.com
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