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Zealand Pharma (ZEAL)

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  3. [verwijderd] 18 september 2018 14:36

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    cws.huginonline.com/Z/136974/PR/20180...

    Company announcement - No. 23/2018

    Zealand Pharma achieves primary and key secondary endpoints in pivotal Phase 3 trial with dasiglucagon for severe hypoglycemia



    All primary and key secondary endpoints successfully achieved
    99% of patients on dasiglucagon recovered from low blood glucose within 15 minutes
    Median time to plasma glucose recovery of 10 minutes with dasiglucagon
    Conference call today, September 18 at 5 PM CET/11 AM ET

    Copenhagen, September 18, 2018 - Zealand Pharma A/S ("Zealand") (Nasdaq: ZEAL), a Copenhagen-based biotechnology company focused on the discovery and development of innovative peptide-based medicines, announces the successful results in the pivotal Phase 3 trial with dasiglucagon for severe hypoglycemia in diabetes.

    Dasiglucagon is a potential first-in-class soluble glucagon analog invented and developed by Zealand. It is in development in the ready-to-use HypoPal® rescue pen for easy, fast and effective treatment of severe hypoglycemia.

    The pivotal Phase 3 trial demonstrates that a single dose of dasiglucagon rapidly increases blood glucose levels in patients with type 1 diabetes following insulin-induced hypoglycemia. The trial compares the glycemic response observed after administration of dasiglucagon with that of placebo and that of currently marketed glucagon, in powder form for reconstitution prior to injection. The primary endpoint was time to plasma glucose recovery, which was defined as first increase in plasma glucose of >/=20 mg/dL (1.1 mmol/L) from baseline without administration of rescue intravenous glucose. 168 subjects were included in the trial: 82 to the dasiglucagon arm, 43 to the placebo arm, and 43 to the GlucaGen® arm. Additional details about the trial are found at clinicaltrials.gov/ct2/show/NCT03378635.

    The primary result demonstrates that the median time to blood glucose recovery was 10 min for dasiglucagon, which was superior to placebo (median: 40 min; p<0.001). The median time to recovery for GlucaGen® was 12 min.
    99% of subjects were recovered from the insulin-induced hypoglycemia within 15 min following dosing with dasiglucagon, versus 2% with placebo and 95% with GlucaGen®.
    Overall, no safety concerns were raised for dasiglucagon within the trial. Nausea and vomiting were reported with similar numbers for dasiglucagon and GlucaGen® (nausea: 55% and 53%, vomiting: 23% and 19%, respectively).

    Adam Steensberg, Executive Vice President and Chief Medical and Development Officer at Zealand Pharma, commented: "I believe that the Phase 3 results are outstanding, and show that dasiglucagon HypoPal® rescue pen could become the fastest rescue treatment for severe hypoglycemia. I am grateful to the patients and clinical investigators who participated in the trial."
    Professor, Dr. Thomas R. Pieber, Medical University of Graz, Department of Internal Medicine, Division of Endocrinology and Diabetology, said: "The results of this Phase 3 trial are impressive in that all patients had clinical relevant increases in blood glucose level within 15 minutes, with a median time to recovery of only 10 minutes. The rapid onset of action suggests that dasiglucagon could become a very attractive treatment option for diabetes patients having a severe hypoglycemic event."
    This is the second Phase 3 trial with positive results for dasiglucagon. The previous Phase 3 trial confirmed dasiglucagon's safety profile. Zealand will soon initiate a Phase 3 trial in pediatric diabetes patients, which is expected to complete in mid-2019.

    Britt Meelby, President and Chief Executive Officer at Zealand Pharma, commented: "The compelling Phase 3 results bring the dasiglucagon HypoPal® rescue pen a significant step closer to a better treatment for people living with diabetes, addressing one of their biggest fears. I am thrilled about this achievement, which represents an important milestone for Zealand in executing our strategy of bringing fully-owned products through registration."

    Conference call today, September 18 at 5 PM CET/11 AM ET

    Zealand's management will host a conference call today, September 18, at 5:00 PM CET/11:00 AM ET to discuss the results of this pivotal phase 3 trial. Participating in the call will be President and Chief Executive Officer Britt Meelby Jensen, Executive Vice President and Chief Financial Officer Mats Blom, and Executive Vice President and Chief Medical & Development Officer Adam Steensberg. The presentation will be followed by a Q&A session.

    The conference call will be conducted in English, and the dial-in numbers are:
    Denmark:....................... +45 35 15 80 49
    United Kingdom:............ +44 (0)330 336 9128
    United States:................ +1 929-477-0448
    Passcode....................... 4510337

    A live audio webcast of the call, including an accompanying slide presentation, will be available via the following link, edge.media-server.com/m6/p/khb3xico, and will be accessible on the Investor section of Zealand's website (www.zealandpharma.com). Participants are advised to register for the webcast approximately 10 minutes before the scheduled start.
  4. MVo_ 18 september 2018 14:37

    • MVo_

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    Halted, en weer door! phase 3 endpoints reached :)

    www.bloomberg.com/press-releases/2018...

    Hier zit nog zoveel in het vat voor de komende maanden en jaren! Slechts 5 tot 6 procent stijging tot op heden, normaliter gaat dit in de double digits bij eerste positieve fase 3 resultaten. Ik blijf lekker zitten.
  7. [verwijderd] 18 september 2018 14:55

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    Denk dat er diverse mensen bezig zijn met het verslag te lezen, volume neemt wel toe... of wordt kunstmatig laag gehouden.. kan ook ... zo groot zijn de volumes van Zealand niet, dus dat is prima te doen..
  8. MVo_ 18 september 2018 14:57

    • MVo_

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    Dat klopt, ik vind dat de hervatting van de handel wel wat te snel is gegaan. Ik kon 2x met mijn ogen knipperen en de halt was gelift, inclusief bijbehorende persberichten. In die tijd had ik het nooit goed kunnen lezen, jammer dat dit tijdens openingstijden moet gebeuren al zeg ik het zelf.
  11. MVo_ 18 september 2018 15:18

    • MVo_

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    Nee volgens mij niet, notering in Kopenhagen is hier regulier. Je zag vlak na de halt een enorme spike, die werd ineens hard gedrukt. Partijtje die instapt?
  13. [verwijderd] 18 september 2018 15:25

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    quote:

    Barend-B schreef op 18 september 2018 15:16:

    Heel vreemd dit...Loopt dit aandeel achter de Nasdaq notering aan? Anders zou het uit die hoek moeten komen denk ik?
    Ze zullen op beiden wel reageren hoor, die trekken wel samen op via algo's.
  17. MVo_ 18 september 2018 16:04

    • MVo_

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    Ik heb verdubbeld op 116,4, lijkt me het gokje waard gezien de ontwikkelingen.

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