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uniQure« Terug naar discussie overzicht

Wat is de waarde van uniQure?

7.806 Posts
Pagina: «« 1 ... 273 274 275 276 277 ... 391 »» | Laatste | Omlaag ↓
  1. Prof. Dollar 22 februari 2017 18:16
    Hemophilia Panel - Key Takeaways from LEERINK's Global Healthcare Conference www.investorvillage.com/smbd.asp?mb=1...

    De opinieleiders blijven de voorkeur geven aan een hoge FIX expressie, ook als andere parameters voor verbetering vatbaar zijn. Het zou mooi zijn als QURE zijdelings een verbeterd Hem. B product kon introduceren...
  2. [verwijderd] 22 februari 2017 19:16
    Spark
    Phase 1/2 trial, in collaboration with Pfizer

    Released data on the first nine participants in the trial, all of whom to date have experienced beneficial effect from the investigational therapy. Eight of the nine participants saw a 100 percent reduction in the use of factor concentrates and in the number of confirmed bleeds. One participant has taken precautionary factor concentrate infusions for suspected bleeds.

    Only two of the first nine participants have experienced asymptomatic, transient elevation in liver enzymes associated with a T-cell response; both were put on a course of tapering corticosteroids and neither has experienced a bleed or needed factor concentrates
  3. Prof. Dollar 22 februari 2017 21:43
    Het is mij nu helder: er komt voorlopig geen academische update uit het Parkinson's programma. In het jaarverslag staat dat uniQure en UCSF hun overeenkomst tussentijds hebben gewijzigd. Het UCSF levert QURE een tussentijdse rapportage met top-line data over eerste twee cohorts. Daarnaast voert UCSF een bridging studie uit waarin het huidige product - dat door een ander is gemaakt - pre-klinisch wordt vergeleken met een product (vector) dat door QURE is verpakt. Kortom, er wordt een onderbouwde business case gemaakt en voorgelegd aan potentiële partners. Hopelijk neemt QURE ons dit kwartaal wel mee in de voortgang.
  8. Prof. Dollar 28 februari 2017 20:38
    Nou, het relatiebeheer bij QURE blijft van likmevestje als dit waar is. twitter.com/biopharmacaster/status/83...

    Op 25 augustus 2016 liet men in het tweede kwartaalverslag weten: "Top-line data, including safety, tolerability and preliminary efficacy results, are expected to be available for presentation in the first quarter of 2017."

    Eerder is in het jaarverslag opgenomen: "The UCSF agreement has been amended such that other obligations we had agreed to complete by specified dates are now related to the receipt of an interim report of the ongoing clinical study at NIH, including obligations to deliver to UCSF specified materials for UCSF to complete a non-clinical study of an AAV2 vector carrying the GDNF gene, to demonstrate equivalent product release specifications of our vector to the vector used in the ongoing NIH sponsored Phase I clinical trial, to pursue a bridging study using our AAV2 vector carrying a GDNF gene, and to use commercially reasonable efforts to proceed, either directly or through a third party licensee, to develop, seek to obtain regulatory approval for and market at least one identified product in the United States and the European Union."
  9. Fartknock 2 maart 2017 14:12
    tools.eurolandir.com/tools/Pressrelea...

    uniQure Announces Presentations at Upcoming March Conferences

    LEXINGTON, Mass. and AMSTERDAM, the Netherlands, March 01, 2017 (GLOBE NEWSWIRE) -- uniQure N.V. (NASDAQ:QURE), a leading gene therapy company advancing transformative therapies for patients with severe medical needs, today announced presentations at the following conferences taking place in March:

    37th Annual Cowen & Co. Healthcare Conference, at the Boston Marriott Copley Place, in Boston Massachusetts.

    •Matthew Kapusta, chief executive officer, will present on Wednesday, March 8th at 10.00 a.m. EST. The live webcast can be accessed through the link displayed in the Investor section of the uniQure website at: uniqure.com/investors-newsroom/events... The webcast replay will be available for at least two weeks following the live event.

    Oppenheimer 27th Annual Healthcare Conference, at the Westin New York Grand Central, in New York City.

    •Matthew Kapusta, chief executive officer, will participate in a Fireside Chat with analyst Hartaj Singh on Tuesday March 21st at 3.55 p.m. EST. The live webcast can be accessed through the link displayed in the Investor section of the uniQure website at: uniqure.com/investors-newsroom/events... The webcast replay will be available for at least two weeks following the live event.

    11th Annual Symposium of the Coalition for Hemophilia B, at the Sawgrass Marriott Golf Resort in Ponte Vedra, Florida.

    •uniQure will be exhibiting throughout the conference from Friday March 31st to Sunday April 2nd.
  10. Prof. Dollar 3 maart 2017 14:11
    uniQure Receives 2017 Frost & Sullivan Manufacturing Leadership Award

    -- Lexington, MA-based Gene Therapy Facility Recognized for Enabling Manufacturing Excellence --

    LEXINGTON, Mass. and AMSTERDAM, the Netherlands, March 03, 2017 (GLOBE NEWSWIRE) -- uniQure N.V. (NASDAQ:QURE), a leader in human gene therapy, today announced that it has been recognized by Frost & Sullivan as a 2017 Manufacturing Leadership Awards winner for outstanding achievement in Engineering & Production Technology Leadership related to its Lexington, Massachusetts gene therapy manufacturing facility.

    uniQure's Lexington-based facility is one of the largest, most versatile gene therapy manufacturing facilities in the world. Over the past four years, uniQure has invested more than $25 million in designing, constructing and equipping its 55,000 square foot facility with state-of-the-art laboratories and commercial-scale production capabilities. The facility offers 500-liter capacity with the ability to expand to up to 2,000 liters when needed.

    "The innovative design of our facility, which incorporated 3D modeling and single-use components, required substantially less upfront capital expenditures and enables us to operate at significantly lower costs compared to other production systems," stated Lance Weed, vice president of operations for uniQure. "Our use of disposable components in our manufacturing process reduces the need for maintenance and testing, lowers the risk of contamination, enables rapid product changeovers, and requires substantially less personnel to operate."

    "uniQure is committed to manufacturing excellence in gene therapy and we are delighted that Frost & Sullivan has recognized our achievements in this regard," stated Matt Kapusta, chief executive officer of uniQure. "We continue to believe that our leading manufacturing capabilities provide us a significant competitive advantage in rapidly delivering gene therapies to patients, including our lead product candidate in hemophilia B, for which we plan to begin a global pivotal study in 2018."

    uniQure will be recognized at the 13th Annual Manufacturing Leadership Awards Gala, which is to be held on the last day of the Manufacturing Leadership Summit, June 12-14, 2017 at the Hyatt Regency Huntington Beach Resort and Spa in Huntington Beach, CA.

    uniqure.com/investors-newsroom/press-...
  12. T. Montana 3 maart 2017 17:52
    quote:

    Prof. Dollar schreef op 3 maart 2017 14:19:

    En ze blijven het flikken... even subtiel door laten schemeren dat start pivotal Hem. B wat langer kan duren. Of worden we eind dit jaar nog verrast?
    Pfff, deze onderscheiding is de spreekwoordelijke sigaar uit eigen doos. Als ze tot niveau dalen ziet het er somber uit.
  15. forum rang 10 DeZwarteRidder 10 maart 2017 15:33
    quote:

    cqtvld schreef op 10 maart 2017 12:25:

    Volgens mij zijn de meeste nederlandse forumleden vertrokken ,toch is het volume nog redelijk te noemen.De prijs die zo gezakt is wat 1 tijd een parel was,de vraag is word dit aandeel nog wat ,met de nieuwe fabriek in Lexington die heel veel kan produceren in de toekomst.....
    Het peperdure personeel in Lexington zit nu gezellig duimen te draaien.....
  18. ch@rter 15 maart 2017 15:34
    Financial Highlights

    Cash Position: As of December 31, 2016, the Company held cash and cash equivalents of $132.5 million, compared with $221.6 million as of December 31, 2015. The decrease in cash was primarily related to the advancement of its clinical and preclinical gene therapy targets, general corporate activities and capital expenditures related to its state-of-the-art manufacturing facility in Lexington, Massachusetts and the build-out of its new research facility in Amsterdam, the Netherlands. The Company intends to significantly reduce capital expenditures in 2017 and 2018 and realize operational cost savings from the strategic restructuring initiated in November 2016. As a result of these initiatives, the Company expects its cash on hand will be sufficient to fund operations into 2019.

    Revenues: Revenue for 2016 was $25.1 million, compared with $10.6 million in 2015 and $6.1 million in 2014. The increases are driven by research activity associated with S100A1 for heart failure, which are fully reimbursed by BMS in accordance with the Company's collaboration agreement.

    R&D Expenses: Research and development expenses were $72.5 million in 2016, compared with $59.1 million in 2015 and $43.8 million in 2014. The increase is related to the continuation of uniQure's Phase I/II clinical study of AMT-060 in hemophilia B, the intensification of the Company's activities to support the research of S100A1, the continued progression of uniQure's preclinical candidate for Huntington's disease, increased activity in the Company's U.S. facility and ongoing studies associated with the Company's collaboration with 4D Molecular Therapeutics to develop next-generation vector serotypes.

    SG&A Expenses: Selling, general and administrative expenses were $26.0 million in 2016, compared with $23.4 million in 2015 and $17.1 million in 2014.

    Other income, generated from research and development subsidies, was $1.5 million in 2016 compared with $0.8 million in 2015 and $1.0 million in 2014.

    Net Loss: The net loss for the fourth quarter of 2016 was $14.7 million, or $0.58 per share, compared with $16.9 million, or $0.69 per share, for the fourth quarter of 2015. The net loss for the full years 2016, 2015 and 2014 was $73.4 million, or $2.93 per share, $82.1 million, or $3.72 per share, and $49.8 million, or $2.91 per share, respectively.
  19. flosz 15 maart 2017 15:38
    Ook niet onbelangrijk.....

    uniQure Announces 2016 Financial Results and Provides Update on Company Progress
    LEXINGTON, Mass. and AMSTERDAM, the Netherlands, March 15, 2017 (GLOBE NEWSWIRE) -- uniQure N.V. (NASDAQ:QURE), a leading gene therapy company developing transformative therapies for patients with severe medical needs, today announces its financial results for the year 2016 and provides an update on company progress.
    "In 2016, we made significant progress across all of our core programs and implemented strategic changes that have strengthened our organization and enhanced focus on our key priorities," stated Matthew Kapusta, chief executive officer of uniQure. "We enter 2017 with a solid financial position and strong clinical data to advance our hemophilia B program into a Phase III study, as well as to progress our gene therapy candidates in Huntington's disease and congestive heart failure towards IND filings.  We believe the achievement of these objectives will deliver meaningful value to shareholders."
    Recent Highlights from 2016
    * Promising Updated Phase I/II Data Presented on AMT-060 at ASH 
    *
    * - Updated results on AMT-060, including up to 52 weeks of follow-up on the first patient cohort receiving 5x1012 gc/kg and up to 26 weeks of follow-up on the second patient cohort receiving a higher dose of 2x1013 gc/kg, were presented at the 58th American Society of Hemophilia Annual Meeting.  
    *
    * - Patients in the first dose cohort that discontinued prophylactic FIX infusions experienced an 85 percent reduction in total FIX usage and a marked reduction in frequency of spontaneous bleeding after treatment with AMT-060, including a complete cessation of spontaneous bleeding during the last 14 weeks of observation.  The five patients in the second dose cohort experienced a near cessation of spontaneous bleeds with only one spontaneous bleed reported in 96 weeks of cumulative observation.  
    *
    * - At both doses, AMT-060 appears to be safe and well-tolerated with no loss of FIX activity, no activation of T-cell response and no development of inhibitors for any of the 10 patients in the study.  None of the 10 patients in the study tested positive for anti-AAV5 antibodies. 
    * ?
    * FDA Breakthrough Therapy Designation Granted for AMT-060 in Hemophilia B  
    *
    * - In January 2017, the U.S. Food and Drug Administration (FDA), granted Breakthrough Therapy Designation for AMT-060 in Hemophilia B patients. The designation is based on results from the ongoing Phase I/II study in patients with severe disease at up to 12 months follow-up. According to FDA data for its fiscal year 2016, the Center for Biologics Research and Review received a total of 23 requests for Breakthrough Therapy designation with only four designations granted, or 17% of all requests. 
    * ?
    * Initiated Regulatory Discussions for Phase III Program in Hemophilia B
    *
    * - Regulatory discussions have now begun as the Company conducted its end-of-Phase II meeting with the FDA earlier this quarter.  The meeting was positive, with the FDA acknowledging the clinical benefit of AMT-060 and expressing no safety concerns based on the Phase I/II data.  The Company anticipates initiating discussions with the European Medicines Association later this year.  Plans to advance the hemophilia B program into late-stage clinical development are ongoing, with a pivotal trial expected to begin in 2018.   
    * ?
    * Preclinical Data Published on AMT-130 in Huntington's Disease 
    *
    * - uniQure is conducting ongoing preclinical studies of AMT-130, its wholly-owned AAV5-based gene therapy product candidate for Huntington's disease. Preclinical data published in a peer-reviewed journal showed sustained and strong wild-type HTT protein silencing in humanized control mice, including knock-down efficiency up to 80% using optimized miHTT scaffolds. Data from additional preclinical studies will be presented during the year at various academic meetings.  uniQure continues to advance AMT-130 towards filing an Investigational New Drug (IND) application to begin clinical studies in 2018.  
    * ?
    * Research Collaboration in Congestive Heart Failure Ongoing with Multiple Preclinical Studies 
    *
    * - Steady progress has been made with collaborator Bristol-Myers Squibb (BMS) in transferring S100A to an insect-cell preparation, manufacturing material for nonclinical and preclinical studies and conducting dose-ranging analyses and comparability studies in healthy and diseased pigs. This ongoing work is in support of an IND application expected to be filed by BMS in 2018.
    * ?
    * Completion of a Company-wide Strategic Review 
    *
    * - uniQure announced the completion of a company-wide strategic review prioritizing programs in hemophilia B, Huntington's disease and cardiovascular disease, consolidating its GMP-manufacturing operations into its Lexington, MA location, streamlining its organization and strengthening its financial position.
    * ?
    * Key Management and Board Appointments 
    *
    * - uniQure strengthened its senior management team with the appointment of Paul Firuta as Chief Commercial Officer, Alex Kuta as Senior Vice President of Regulatory Affairs, Maria Cantor as Senior Vice President, Investor Relations & Communications, Jonathan Garen as Chief Business Officer and Maiken Keson-Brookes as Senior Vice President and General Counsel, all of whom are based in the U.S. 
    *
    * - Following its Annual General Meeting, the Company completed corporate governance changes in transitioning from a two-tier Supervisory Board and Management Board to a single Board of Directors structure with executive and non-executive members. In addition, the Company appointed Jack Kaye, a seasoned financial executive with more than 40 years of diversified experience, to its Board of Directors. 
    *
    * Matthew Kapusta was appointed by the Board of Directors as Chief Executive Officer (CEO). Mr. Kapusta had previously served as interim CEO and as Chief Financial Officer of the Company.  Mr. Kapusta will continue to serve as an executive member of the uniQure Board of Directors.

    www.uniqure.com/investors-newsroom/pr...
    Bijlage:
7.806 Posts
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