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Home  /  Forum  /  BioPharma  /  Zealand Pharma (ZEAL)

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BioPharma« Terug naar discussie overzicht

Zealand Pharma (ZEAL)

192 Posts
Pagina: «« 1 ... 5 6 7 8 9 10 »» | Laatste | Omlaag ↓
  4. Wil Helmus 20 september 2019 15:47
    quote:

    KVE83 schreef op 20 september 2019 14:35:

    Wil Helmus,

    Wat voor nieuws wordt er verwacht volgende week. Resultaten test resultaten ?
    Laatste fase 3 resultaten dasiglucagon:
    The final Phase 3 trial that will complete our NDA application is in pediatric diabetes patients and is still ongoing. Recruitment for this study involving children has proved challenging and results are now expected in September 2019. Accounting for this delay in pediatric patient recruitment, submission of the new drug application (NDA) to the U.S. FDA is now expected early 2020.

    www.zealandpharma.com/dasiglucagon-re...
  6. Wil Helmus 20 september 2019 22:09
    Geen dank. Zit er zelf al een tijdje in. Toen Van Herk zijn eerste belang nam. Daarna steeds bijgekocht. Inmiddels in verhouding tot mijn andere aandelen iets teveel aangeschaft. Ik ga volgende week uit van positief nieuws. Als het negatief zou zijn hadden we vanavond wel een persbericht gehad lijkt me. Daarna maar even kijken wat ik doe. Verkoop misschien toch een deel na eventuele positieve fase 3 resultaten
  7. Wil Helmus 23 september 2019 21:30
    Zealand Pharma initiated with a Buy at Guggenheim Guggenheim analyst Etzer Darout started Zealand Pharma (ZEAL) with a Buy rating, identifying the company and MyoKardia (MYOK) as "diamonds in the rough" that are focused on therapies for cardiovascular and metabolic disorders and targeting therapeutic segments where patients are more homogenous and/or targets are validated. He sees Zealand's major near-term driver being gleplagutide's pivotal data in patients with short bowel syndrome, due in the second half of 2020. He has a price target of DKK 235 on the local shares of ZEAL-DK, noting that Guggenheim is terminating coverage of the ADR shares of Zealand.

    Read more at: 
    thefly.com/landingPageNews.php?id=296...
  10. rbot 24 september 2019 12:47
    Company announcement – No. 35 / 2019

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

    Median time to recovery from low blood glucose in pediatric patients was 10 minutes following dasiglucagon injection, confirming the fast recovery also seen in adult patients with diabetes

    The study results support the use of same dose of dasiglucagon in adults and children

    The dasiglucagon HypoPal® rescue pen is being developed as an easy-to-use, fast and effective rescue treatment for diabetes patients having a severe hypoglycemic event

    On-track for submission of New Drug Application to U.S. FDA in early 2020


    Copenhagen, September 24, 2019 – Zealand Pharma A/S (“Zealand”) (Nasdaq: ZEAL), a Copenhagen-based biotechnology company focused on the discovery and development of innovative peptide-based medicines, announces positive results in the pediatric 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 being developed in the ready-to-use HypoPal® rescue pen: an auto-injector for easy, fast and effective treatment of severe hypoglycemia in people with diabetes.

    The trial compared the glycemic response observed after induction of hypoglycemia and administration of dasiglucagon (0.6 mg) with that of placebo and that of GlucaGen® (1 mg), a 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. 42 pediatric subjects (divided into age groups of 6-11 and 12-17 years) were included in the trial: 21 in the dasiglucagon arm, 11 in the placebo arm, and 10 in the GlucaGen® arm. Additional details about the trial are found at clinicaltrials.gov/show/NCT03667053.

    The primary result demonstrated that the median time to blood glucose recovery was 10 minutes for dasiglucagon, which was superior to placebo (median: 30 min; p<0.001). The median time to recovery for GlucaGen® was 10 minutes.

    Overall, no safety concerns were raised for dasiglucagon within the trial. Nausea and vomiting were reported with dasiglucagon in both age groups (6-11 years; nausea: 25% and vomiting: 25%; 12-17 years; nausea: 92% and vomiting: 67%). For GlucaGen® (6-11 years; nausea: 50% and vomiting: 25%; 12-17 years; nausea: 17% and vomiting: 0%).

    Adam Steensberg, Executive Vice President and Chief Medical and Development Officer at Zealand Pharma, commented: “I am thrilled with yet another positive Phase 3 trial outcome for our dasiglucagon HypoPal® rescue pen program. This study in children with diabetes confirms the potential for fast and effective rescue from severe hypoglycemia also seen in our Phase 3 trials in adults, and keeps us on track for submitting the new drug application to the U.S. FDA in early 2020.”

    This is the fourth consecutive Phase 3 trial with positive results for dasiglucagon. The previous immunogenicity and pivotal Phase 3 trials established dasiglucagon’s safety profile and fast onset of action when administered via both the HypoPal® rescue pen and the pre-filled syringe in adult patients with type 1 diabetes.

    “I believe that the dasiglucagon HypoPal® rescue pen and its innovative features have the potential to significantly improve management of severe hypoglycemia in diabetes,” said Emmanuel Dulac, President and Chief Executive Officer at Zealand Pharma. “Dasiglucagon has repeatedly demonstrated fast recovery from hypoglycemia, typically within 10 minutes from injection. Speed of recovery is critical in any rescue situation, and our vision is for every patient at risk of severe hypoglycemia to have the HypoPal® rescue pen readily available.”
  13. Wil Helmus 24 september 2019 13:20
    Ik denk om eerlijk te zijn dat het grootste deel al ingeprijst is. Helemaal zeker weet je het natuurlijk nooit, maar het lag in de lijn der verwachting dat de pediatric fase 3 resultaten positief zouden uitpakken. De koers is hier ook al behoorlijk naar opgelopen. Ik verwacht de komende tijd toch een kleine daling. De volgende grote trigger zal waarschijnlijk gleplagutide's fase 3 resultaten zijn en deze worden pas haverwege 2020 verwacht. Neemt niet weg dat er nog veel moois aan zit te komen de komende jaren
  14. Wil Helmus 26 september 2019 12:49
    quote:

    rbot schreef op 24 september 2019 13:06:

    Wat is jullie verwachting?

    Het lijkt erop dat het nieuws nog een beetje door moet komen. Ik verwacht komende dagen wel een aantal analistenrapporten en koersdoelverhogingen.

    Koers kan nog verder doorstijgen komende dagen
    Aandeel blijft prima liggen. Ik had zelf toch wel een kleine terugval verwacht.
  16. Wil Helmus 2 oktober 2019 22:44
    Deze kunnen we volgens mij ook nog verwachten:
    Zealand is developing dasiglucagon as a potential treatment option for CHI, a rare disease which affects mainly newborns and toddlers with devastating consequences including brain damage and often requires surgical intervention, pancreatectomy, to manage the condition. The FDA’s approval of our IND application allows us to proceed into Phase 3 development of dasiglucagon and we will conduct two Phase 3 trials. The first trial is ongoing, and the second trial is expected to initiate mid 2019.
  19. Wil Helmus 15 oktober 2019 20:03
    Zealand Pharma upgraded to Buy from Neutral at Goldman Sachs Goldman Sachs analyst Graig Suvannavejh upgraded Zealand Pharma to Buy from Neutral with a $41 price target. The analyst cites increased optimism on the company's pipeline and commercial execution for the upgrade. He raised his revenue estimates for Zealand's two keys products, glepaglutide and dasiglucagon HypoPal. With new senior leadership in place, Zealand Pharma "finds itself on the cusp of transforming" into a commercial stage company over the next few years, Suvannavejh tells investors in a research note. The analyst's 12-month price target implies 70% upside in the shares.

    Read more at: 
    thefly.com/landingPageNews.php?id=297...
192 Posts
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