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Zealand Pharma (ZEAL)

1. moi!! 23 maart 2021

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   Zealand Pharma Announces FDA Approval of Zegalogue® (dasiglucagon) injection, for the Treatment of Severe Hypoglycemia in People with Diabetes
   March 22, 2021 17:50 ET | Source: Zealand Pharma
   
   Company announcement – No. 16 / 2021
   
   Zealand Pharma Announces FDA Approval of Zegalogue® (dasiglucagon) injection, for the Treatment of Severe Hypoglycemia in People with Diabetes
   
   Zegalogue will be available in both an auto injector and a prefilled syringe for the treatment of severe hypoglycemia in patients with diabetes age 6 or older
   Approval based on results from three pivotal trials in adults and children with diabetes, showing median time to blood glucose recovery from severe hypoglycemia of 10 minutes following injection of 0.6 mg/0.6 mL Zegalogue
   Company to host conference call Tuesday, March 23 at 1:00PM CET (8:00AM ET)
   Copenhagen, DK and Boston, MA, U.S. March 22, 2021 – Zealand Pharma A/S (Nasdaq: ZEAL) (CVR-no. 20045078,) a biotechnology company aspiring to deliver innovation with novel peptide therapeutics, announced today that the U.S. Food and Drug Administration (FDA) has approved Zegalogue® (dasiglucagon) injection for the treatment of severe hypoglycemia in pediatric and adult patients with diabetes aged 6 years and above.
   
   “This approval will help enable appropriate children and adults with diabetes to be able to address sudden and severe hypoglycemia, which can quickly progress from a mild event to an emergency,” said Dr. Jeremy Pettus, MD, Assistant Professor of Medicine at the University of California San Diego. “The magnitude and consistency of effect seen in the Phase 3 pivotal studies is clinically meaningful as minutes matter in severe hypoglycemia. Zegalogue provided resolution of severe hypoglycemia following administration, with a median time to blood glucose recovery of 10 minutes across these clinical studies.”
   
   Severe hypoglycemia is an acute, life-threatening condition resulting from a critical drop in blood glucose levels associated primarily with insulin therapy and is one of the most feared complications of diabetes treatment1. Children with diabetes on insulin are particularly affected, with 7 out 100 children up to the age of 18 reporting severe hypoglycemia in the previous 6 months2. While patients have the ability to monitor and adjust their blood glucose levels to remain in proper glycemic control, it’s not always possible to prevent a severe hypoglycemic event.
   
   “The U.S. FDA approval of Zegalogue is an exciting achievement for both patients and Zealand,” said Emmanuel Dulac, President and CEO of Zealand Pharma. “We would like to thank the trial participants, their families and caregivers, the investigators and their staff, and our employees who made the Zegalogue clinical studies and this resulting approval possible. We are committed to helping people with diabetes manage the potential consequences of their disease and look forward to making Zegalogue available in the U.S. in June. Field sales, market access and medical teams, along with comprehensive patient support services, are in place to maximize awareness to healthcare providers and preparedness to patients affected by severe hypoglycemia.”
   
   The FDA approval was based on efficacy results from three randomized, double-blind, placebo-controlled multicenter Phase 3 studies of Zegalogue in children aged 6 to 17 and in adults with type 1 diabetes. The primary efficacy endpoint for all three studies was time to plasma glucose recovery (treatment success), defined as an increase in blood glucose of =20 mg/dL from time of administration, without additional intervention within 45 minutes. The primary endpoint was successfully achieved across the adult and pediatric studies with a significantly faster median time to blood glucose recovery of only 10 minutes following Zegalogue administration compared to 30-45 minutes placebo. In the main Phase 3 adult trial 99% of patients recovered within 15 minutes.
   
   In these studies, the most common adverse events reported (=2%) were nausea, vomiting, headache, diarrhea, and injection site pain in adults; and nausea, vomiting, headache, and injection site pain in pediatrics.
2. moi!! 23 maart 2021 00:02

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   Dus "approval"! Waar kan het koers naar toe?
3. KVE83 23 maart 2021 07:12

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   Gisteren op de Nasdaq nabeurs gesloten op 224 DKK omgerekend. Het kan denk wel wel weer naar de 300DK gaan. Het heeft een markt van 1,5 miljard. Alleen weet ik niet hoeveel andere bedrijven hetzelfde medicijn maken.
4. Comeback 23 maart 2021 07:41

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   YES !!!!!!! Geweldig nieuws wat zich zeker gaat vertalen in een fors hogere koers !! Ben benieuwd waar we vandaag gaan eindigen.
5. KVE83 23 maart 2021 09:01

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   zealand opent op 220 DK..
6. Ron Kerstens 23 maart 2021 12:25

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   quote:

   KVE83 schreef op 23 maart 2021 07:12:

   Gisteren op de Nasdaq nabeurs gesloten op 224 DKK omgerekend. Het kan denk wel wel weer naar de 300DK gaan. Het heeft een markt van 1,5 miljard. Alleen weet ik niet hoeveel andere bedrijven hetzelfde medicijn maken.
   

   Er zijn bij mijn weten twee goedkeuringen verleend in 2019, Eli Lilly (intranasale glucagon BAQSIMI) en Xeris Phamarma (Gvoke). Beide kosten ca 300 dollar per flesje.
   
   Maar toch een geruststelling dat de goedkeuring erdoorheen is en ze het op de markt kunnen brengen. Dasiglucagon zit nog in 3 andere lopende programma's dus dit is een goede start.
7. Comeback 23 maart 2021 13:04

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   quote:

   Ron Kerstens schreef op 23 maart 2021 12:25:

   [...]
   
   Er zijn bij mijn weten twee goedkeuringen verleend in 2019, Eli Lilly (intranasale glucagon BAQSIMI) en Xeris Phamarma (Gvoke). Beide kosten ca 300 dollar per flesje.
   
   Maar toch een geruststelling dat de goedkeuring erdoorheen is en ze het op de markt kunnen brengen. Dasiglucagon zit nog in 3 andere lopende programma's dus dit is een goede start.
   

   Verschillende programma's in phase II en III ... net dat maakt Zealand Pharma zo aantrekkelijk. Het eerste product nu op de markt is inderdaad een geweldige opsteker. En zoals al aangegeven .. ze hebben recent cash opgehaald om de programma's verder te financieren. The only way is up ...
8. rbot 23 maart 2021 14:47

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   Toch wel erg lauw ontvangt van die goede nieuws. Koers heeft al fors hoger gestaan toen fase 3 resultaten gepubliceerd werden. Kan het zijn dat er in de tussentijd meer concurrentie is gekomen op dit domein?
9. Sanda 25 maart 2021 11:03

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   En ondertussen weer flink omlaag...
10. KVE83 12 april 2021 16:00

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    Weet iemand hoeveel de markt waarde heeft waar Zealand goedkeuring voor heeft gekregen ?
    Vind dat de koers aardig rustig blijft na goedkeuring van de FDA...
11. Ron Kerstens 20 april 2022 16:35

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    Al tijden niet meer naar dit aandeel gekeken, heb ze indertijd verkocht op 220DK. Ik zie nu tot mijn verbazing dat de koers op 90DK staat.
    
    Ik zag net onderstaand artikel;
    
    It wasn’t supposed to be this way. Zealand Pharma should be in the honeymoon glow of its first drug launch with a drug approved less than a year ago. Instead, it's losing its CEO and shedding 90% of its U.S. workforce.
    
    What went wrong? It’s an issue plaguing a growing number of biotechs that are launching their first drugs but struggling with the heavy lifting required on the commercial side. Combine this with the hostile COVID environment, and a launch can swiftly implode.
    
    Zealand grabbed an FDA approval last May for Zegalogue, designed to treat severe hypoglycemia in diabetes patients, as well as V-GO, its wearable for blood sugar control.
    
    But sales have disappointed, falling below what Zealand had believed it could make. In its financials released March 10, the Denmark-based company said it was expecting product sales of 190 million Danish krone ($29.3 million), plus or minus 10%, a downgrade on its former estimate of 220 million Danish krone ($33.9 million).
    Related
    Zealand, underwhelmed by Sanofi's Soliqua sales, plans to ride solo on future launches
    
    Wednesday, it cut that figure again. Sales from its two products are “now expected to be DKK 115 million +/- 10%," the company said in an update. That's a little more than half its inital estimate.
    
    So, out comes the ax. It fell first on CEO Emmanuel Dulac, who is already out the door and has been replaced by Adam Steensberg, M.D., who had been head of R&D and CMO. The idea is to restructure around Zealand’s pipeline in the hope of finding another successful product to sell.
    
    And that means "streamlining" its commercial operations. Translation: The company will cull 90% of its U.S. workforce and cut back its annual operating expenses by at least 35% compared to 2021, the company said in a statement.
    
    Zealand plans to look for partners to handle Zegalogue and V-Go, presumably hoping to find a company that can help it actually sell its two approved products.
    
    “[W]e believe that seeking commercial partnerships will generate more value for the company and shareholders as we transform the company into a more focused and cost-effective organization," Steensberg said.
    
12. Ron Kerstens 7 april 2023 14:33

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    En bovenstaande 90 DK blijkt tevens het dieptepunt te zijn geweest, nu weer 220 DK. Wonderlijk koersverloop toch altijd bij de biotechs.
13. No Problama 22 juni 2024 14:48

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    Shares for Zealand Pharma rose by over 17% on Friday, after the Danish biotech firm announced positive trial results for petrelintide, a new weight loss drug the company said could compete against Novo Nordisk’s Ozempic and Eli Lilly’s Mounjaro.
    Forbes.com
14. wiegveld 5 juli 2024 13:53

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    belangrijke tip voor ons Nederlanders.
    zealand is interessant bedrijf en dat heeft ook de ooit grote aandeelhouder van GLPG gezien. van Herk.
    
    Zealand Pharma major shareholder announcement: Van Herk Investments
    
    Copenhagen, Denmark, 28 June 2024 – 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, today announces the receipt on 28 June 2024 of notification pursuant to Section 38 of the Danish Capital Markets Act from the following major shareholders:
    
    As from 28 June 2024 Van Herk Investments B.V. (Dutch registration no. 59055057) holds nominally 6,874,960 shares (each share carrying one vote) in Zealand Pharma A/S, corresponding to 9.68% of the total share capital and total voting rights Zealand Pharma A/S.
    
    Van Herk Investments B.V. is 100% owned by Van Herk Investments THI B.V. which is 100% owned by Van Herk Private Equity Investments B.V. (Dutch registration no. 58894543, which is ultimately owned and controlled by Mr. Adrianus van Herk.
    
    Van Herk Management Services B.V. (Dutch registration no. 24377325) controls and exercises the voting rights on behalf of Van Herk Investments B.V., and accordingly, Van Herk Management Services B.V controls and exercises the voting rights on nominally 6,874,960 shares (each share carrying one vote), corresponding to 9,68% of the total share capital and total voting rights in Zealand Pharma A/S.
    
    Van Herk Management Services B.V., is controlled by OGBB A. van Herk B.V. (Dutch registration no. 24160906), which is controlled by A. van Herk Holding B.V. (Dutch registration no. 24160780), which is ultimately controlled by Mr. Adrianus van Herk.
    
    Please see further details in the attached notification forms