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Home  /  Forum  /  BioPharma  /  Zealand Pharma (ZEAL)

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Zealand Pharma (ZEAL)

192 Posts
Pagina: «« 1 ... 3 4 5 6 7 ... 10 »» | Laatste | Omlaag ↓
  1. Wil Helmus 28 mei 2019 12:07
    Zealand Pharma to attend Jefferies and Goldman Sachs Global Healthcare Conferences

    Press release – No. 12 / 2019

    Zealand Pharma to attend Jefferies and Goldman Sachs Global Healthcare Conferences

    Copenhagen, May 27, 2019 – Zealand Pharma Chief Executive Officer Emmanuel Dulac, Chief Medical and Development Officer Adam Steensberg, and Senior Vice President of Corporate and Business Development Marino Garcia will attend the Jefferies 2019 Global Healthcare Conference on June 6, 2019 in New York. Zealand Pharma is scheduled to present at 2:30 PM Eastern.

    On June 12, 2019, Emmanuel Dulac and Adam Steensberg will attend the Goldman Sachs 40th Annual Global Healthcare Conference in Rancho Palos Verdes, California. Zealand Pharma is scheduled to present at 1:20 PM Pacific.
  2. Wil Helmus 31 mei 2019 16:15
    2 van de 3 fase 3 trials met succes achter de rug voor dasiglucagon. Na een eventuele goedkeuring begin 2020 heeft Zealand een medicijn in huis met een marktpotentieel van een miljard dollar per jaar. Verder genoeg cash in huis, met glepaglutide nog een fase 3 medicijn in de pijplijn, orphan drug approbal voor dasiglucon en glepaglutide, meerdere samenwerkingsverbanden enz. enz. Ik voorzie een mooie toekomst voor dit bedrijf
  3. Wil Helmus 6 juni 2019 13:15

    Beta Bionics and Zealand Pharma announce superior glycemic control in Phase 2 home-use clinical trial testing the iLet™ bionic pancreas using dasiglucagion
    First home-use trial of the iLet Bionic Pancreas System using pre-filled cartridges of dasiglucagon compatible with iLet has been successfully completed

    The preliminary study results reveal superior blood glucose control during the study period that used the bihormonal configuration of the iLet with dasiglucagon compared to the period that used the insulin-only configuration

    iLet therapy was initialized with body weight only, with no device training periods, and with no physician intervention to optimize therapy


    Boston, MA and Copenhagen, Denmark – June 6, 2019 – Beta Bionics, Inc. and Zealand Pharma A/S (NASDAQ: ZEAL, company announcement No. 19/2019) announced today that a home-use study of dasiglucagon in the iLet™ Bionic Pancreas System has been successfully completed.

    The iLet, developed by Beta Bionics, is the world’s first autonomous bionic pancreas device — a bihormonal system leveraging lifelong machine learning and artificial intelligence to deliver insulin and glucagon analogs for the autonomous treatment of type 1 diabetes (T1D). In addition to dosing insulin, the iLet doses dasiglucagon — a glucagon analog with a unique stability profile in a ready-to-use aqueous solution. Dasiglucagon is in development by Zealand Pharma.

    This home-use clinical trial was conducted by Dr. Steven Russell and his clinical research team at the Massachusetts General Hospital (MGH) and was designed as a randomized, two-period, cross-over trial to assess whether the iLet operated as intended. The trial compared operational performance of the iLet in the insulin-only configuration for one week versus the bihormonal configuration for one week in 10 adult participants with T1D. Trial participants started therapy by entering only their body weight into the device; there was no device training period and no physician intervention to optimize therapy. The iLet is designed to autonomously and continuously adapt to each patient’s changing insulin needs. This adaptation is typically most pronounced in the first 24 hours after the initiation of therapy.

    The iLet operated as expected, meeting the primary aim of the study. Preliminary data analysis demonstrated that the bihormonal iLet using dasiglucagon provided superior glycemic control over the insulin-only iLet. During the bihormonal period, participants achieved a mean glucose level, as measured by continuous glucose monitoring (CGM), of 139 mg/dL on days 2–7 of use, versus 149 mg/dL during the insulin-only period (p <0.01). During the bihormonal period, participants spent 79% of the time with their CGM glucose level in range (70–180 mg/dL) on days 2–7 of use, versus 71% during the insulin-only period (p<0.01). During the bihormonal period, 90% of participants had a mean CGM glucose level of < 154 mg/dL, a level that corresponds to an HbA1c level of 7%, the therapeutic goal for adults recommended by the American Diabetes Association. In contrast, 50% of participants had a mean CGM glucose level < 154 mg/dL during the insulin-only period.

    Hypoglycemia was observed to be low throughout the study. The mean percentage of time CGM glucose was < 54 mg/dL was 0.3% during the bihormonal period versus 0.6% during the insulin-only period. The mean percentage of time CGM glucose was < 70 mg/dL was 2.4% during the bihormonal period versus 3.6% during the insulin-only period.

    “We are extremely pleased to have now tested the performance of our bihormonal iLet Bionic Pancreas System with dasiglucagaon — the first-ever, liquid-stable glucagon analog — in a convenient ready-to-use, pre-filled cartridge designed to fit our system,” said Ed Damiano, Co-founder and President & CEO of Beta Bionics. “Preliminary results from this trial have helped reaffirm the final implementation of our dosing algorithms in the bihormonal configuration of the iLet. I am ecstatic about this historic achievement for Beta Bionics, Zealand Pharma, and our clinical collaborators at MGH, and I am looking forward with eager anticipation to the day when people with T1D can enjoy the real-life benefits of combining ready-to-use dasiglucagon with the iLet.”

    Beta Bionics and Zealand Pharma have partnered to carry out several co-development activities with the primary goal of obtaining regulatory approval to use dasiglucagon in the bihormonal configuration of the iLet.

    “The bihormonal iLet Bionic Pancreas System demonstrated tight glycemic control in a home-use setting with dasiglucagon,” commented Emmanuel Dulac, President and Chief Executive Officer at Zealand Pharma. “We look forward to proceeding with the Phase 3 trial and continuing to demonstrate the transformational opportunity that the iLet with dasiglucagon could offer for improved and fully automated diabetes management.”

    Beta Bionics and Zealand Pharma are planning for a Phase 3 pivotal trial testing the bihormonal configuration of the iLet with dasiglucagon in 2020. That trial is intended to support regulatory submission to the U.S. FDA of a pre-market approval (PMA) application and a new drug application (NDA) for the bihormonal configuration of the iLet with dasiglucagon in people with T1D.
  4. Wil Helmus 11 juni 2019 08:21
    Zealand Pharma presents dasiglucagon pivotal Phase 3 trial data at the 79th Scientific Sessions of the American Diabetes Association (ADA)

    Press release – No. 14 / 2019

    Zealand Pharma presents dasiglucagon pivotal Phase 3 trial data at the 79th Scientific Sessions of the American Diabetes Association (ADA)

    The pivotal Phase 3 trial demonstrates that a single dose of dasiglucagon rapidly increases blood glucose levels in type 1 diabetes patients with low plasma glucose
    The median time to plasma glucose recovery was 10 min following dasiglucagon injection, with 99% of patients having recovered within 15 minutes

     

  5. [verwijderd] 13 juni 2019 11:35
    Technische analyse.
    Het aandeel doorbrak op 3 juni de steun van het (opgaande) trendkanaal. Op dit moment (koers circa 143 dkk) komt het aandeel weer in dat trendkanaal. De Stoch RSI geeft aan dat er nog ruimte voor stijging is ("oversold"). Zie plaatje: invst.ly/b035m
    Mits er geen negatieve berichten verschijnen, zou ik zeggen dat de kans groot is dat de stijging nog even doorzet.
  8. Wil Helmus 26 juni 2019 08:17
    Zealand Pharma doses first subject in Phase 1 clinical trial with potential next generation dual-acting peptide therapeutic for short bowel syndrome

    Press release – No. 16 / 2019

    Zealand Pharma doses first subject in Phase 1 clinical trial with potential next generation dual-acting peptide therapeutic for short bowel syndrome

    Short bowel syndrome (SBS) is a complex chronic and severe condition associated with reduced or complete loss of intestinal function and significant unmet medical need
     ZP7570 is a long-acting peptide therapeutic with dual activity on the GLP-1 and GLP-2 receptors
     Pre-clinical and clinical data suggest that the combined GLP-1 and GLP-2 activity may work synergistically to further improve intestinal function in patients with SBS

    Copenhagen, June 26, 2019 – Zealand Pharma A/S (“Zealand”) (NASDAQ: ZEAL) (CVR-no. 20 04 50 78), a Copenhagen-based biotechnology company focused on the discovery and development of innovative peptide-based medicines, announces the dosing of the first subject in a Phase 1 clinical trial to evaluate the safety and tolerability of ZP7570 as a potential first-in-class next generation treatment of short bowel syndrome (SBS).

    The study is a randomized, double-blind, placebo-controlled, single ascending dose trial in 64 healthy subjects, randomized to ZP7570 or placebo within eight cohorts.

    ZP7570, a long-acting, dual GLP-1/GLP-2 peptide therapeutic, is designed to further improve management of SBS and may represent a next level of innovation for helping SBS patients to further realize full potential for intestinal rehabilitation. GLP-2 primarily increases the absorptive capacity of the intestine, whereas GLP-1 is believed to act by reducing gastrointestinal motility, thereby allowing more time for the fluids and nutrition to be absorbed. The properties of ZP7570 may also allow for therapeutic opportunities in other gastrointestinal diseases.

    “We are committed to changing the lives of people with short bowel syndrome and see good progress in our Phase 3 clinical trial with glepaglutide, a potential best-in-class long-acting GLP-2 analog for treatment of SBS,” commented Adam Steensberg, Executive Vice President and Chief Medical and Development Officer at Zealand Pharma. “Initiation of this Phase 1 clinical trial with ZP7570, a dual- GLP-1/GLP-2 acting peptide, marks yet another important milestone in our efforts to bring innovative therapeutics to patients living with SBS.”

  9. [verwijderd] 28 juni 2019 07:43
    De koers van 141DKK is in het verleden al meerdere malen een weerstand gebleken. En ook nu weer. Zie plaatje: invst.ly/b4j5r

    De volumes zijn laag en dat helpt ook niet om deze weerstand te doorbreken. Echter, vanaf aanstaande maandag zitten we in Q3 en in dat kwartaal worden de fase 3-resulaten verwacht van het medicijn tegen severe Hypoglycemia. En die lijken veelbelovend!
  11. [verwijderd] 29 juni 2019 09:11
    Gisteren heeft de koers een krachtig signaal afgegeven. De koers was als het ware in een hoekje gedreven (blauwe driehoek in plaatje) en was zo op een punt gekomen dat óf de weerstand doorbroken moest worden óf de steun van de opgaande trendlijn. Dat laatste gebeurde én op overtuigende wijze.
    Zie plaatje ter verduidelijking: invst.ly/b4uh4
  12. [verwijderd] 29 juni 2019 09:29
    Correctie....
    Gisteren heeft de koers een krachtig signaal afgegeven. De koers was als het ware in een hoekje gedreven (blauwe driehoek in plaatje) en was zo op een punt gekomen dat óf de weerstand doorbroken moest worden óf de steun van de opgaande trendlijn. Dat EERSTE gebeurde én op overtuigende wijze.
    Zie plaatje ter verduidelijking: invst.ly/b4uh4
  13. Wil Helmus 29 juni 2019 11:27
    quote:

    Mr. Buffett schreef op 28 juni 2019 07:43:

    De koers van 141DKK is in het verleden al meerdere malen een weerstand gebleken. En ook nu weer. Zie plaatje: invst.ly/b4j5r

    De volumes zijn laag en dat helpt ook niet om deze weerstand te doorbreken. Echter, vanaf aanstaande maandag zitten we in Q3 en in dat kwartaal worden de fase 3-resulaten verwacht van het medicijn tegen severe Hypoglycemia. En die lijken veelbelovend!
    Klopt, ik heb er alle vertrouwen in. In het PB van 14 mei staat het volgende:

    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.

    Gaat dus waarschijnlijk september worden.
  15. [verwijderd] 3 juli 2019 08:09
    Een ander Deens biotech-bedrijf dat technisch gezien interessant lijkt, is Bavarian Nordic.
    In 2017 verloor het aandeel de helft van haar waarde vanwege stopzetten van een phase 3-onderzoek naar prostaatkanker en is de afgelopen twee jaar in een neergaande spiraal terecht gekomen.

    Eind mei heeft het aandeel dat neergaande spiraal echter doorbroken en lijkt weer de weg naar boven te zoeken. Zie plaatje: invst.ly/b5v9q

    Het bedrijf heeft daarnaast een brede pijplijn: www.bavarian-nordic.com/pipeline/pipe...
  17. Wil Helmus 7 juli 2019 19:39
    ZEAL in Uptrend: 50-day Moving Average broke above 200-day Moving Average on March 11, 2019

    A buy signal is indicated by this change in price, due to the trend repositioning higher. In 1 of 1 cases where ZEAL's 50-day Moving Average crossed above its 200-day Moving Average, its price rose further within the subsequent month. The odds of a continued Uptrend are 90%.

    Bijlage:
  19. Wil Helmus 21 juli 2019 11:00
    Uit een eerdere conference call:

    Glucagon Hypoglycaemia Rescue Market Has Substantial Value Potential
    On page five, we see the current and expected volume and value for the glucagon hypoglycaemia rescue market. We believe this is an underpenetrated market due to the shortcomings of the current product as well as lack of promotion for many decades. With new and better products that are easier to administer, we believe the rescue products will grow significantly and reach $1 billion in the US alone by 2030. Now, I’ll turn it over to Adam to discuss the pivotal Phase 3 trial and results in detail.
192 Posts
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