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Bavarian Nordic — Marts 2020

Planlagt Fastgjort Låst Flyttet Bavarian Nordic
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  • exitnuE Offline
    exitnuE Offline
    exitnu
    wrote on sidst redigeret af
    #289

    Copenhagen, March 31, 2020 In reference to Zealand Pharma A/S (Zealand) (NASDAQ: ZEAL) (CVR-no. 20 04 50 78) company announcement 09/2020 published March 26, 2020, regarding a private placement and directed issue of 741,816 new shares of the company (the New Ordinary Shares), Zealand Pharma A/S (Zealand) announces that it has today increased its share capital by DKK 741,816, divided into 741,816 New Ordinary Shares with a nominal value of DKK 1 each.

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    • exitnuE Offline
      exitnuE Offline
      exitnu
      wrote on sidst redigeret af
      #290

      The gross proceeds from the issuance of the New Ordinary Shares amounts to DKK 137,236,000.

      Following the registration of the New Ordinary Shares with the Danish Business Authority, Zealands share capital amounts to DKK 36,887,952 divided into 36,887,952 shares with a nominal value of DKK 1 each.

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      • exitnuE Offline
        exitnuE Offline
        exitnu
        wrote on sidst redigeret af
        #291

        The New Ordinary Shares rank pari passu with Zealands existing shares and carry the same dividend and other rights. Each New Ordinary Share carries one vote at Zealands general meetings. Zealand only has one class of shares.

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        • exitnuE Offline
          exitnuE Offline
          exitnu
          wrote on sidst redigeret af
          #292

          The New Ordinary Shares have been issued today and are expected to be admitted to trading on Nasdaq Copenhagen on April 1, 2020 in Zealands permanent ISIN code DK0060257814.

          The amendments to Zealands articles of association required by the capital increase have been registered today with the Danish Business Authority.

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          • exitnuE Offline
            exitnuE Offline
            exitnu
            wrote on sidst redigeret af
            #293

            ... stay tuned ...

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            • exitnuE Offline
              exitnuE Offline
              exitnu
              wrote on sidst redigeret af
              #294

              Zealand Pharma submits New Drug Application to the U.S. Food and Drug Administration for the Dasiglucagon HypoPal Rescue Pen for treatment of severe h

              Press Release No. 04 / 2020

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              • exitnuE Offline
                exitnuE Offline
                exitnu
                wrote on sidst redigeret af
                #295

                Zealand Pharma submits New Drug Application to the U.S. Food and Drug Administration for the Dasiglucagon HypoPal Rescue Pen for treatment of severe hypoglycemia

                The Dasiglucagon HypoPal Rescue Pen New Drug Application represents a major milestone in Zealand Pharmas efforts to bring life changing therapies to people with diabetes

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                • exitnuE Offline
                  exitnuE Offline
                  exitnu
                  wrote on sidst redigeret af
                  #296

                  The submission encompasses three Phase 3 trials which met all primary and key secondary endpoints with a median time to recovery from hypoglycemia of only 10 minutes

                  Zealand Pharma remains on-track to build commercial infrastructure in the U.S. for the anticipated Dasiglucagon HypoPal Rescue Pen launch in 2021

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                  • exitnuE Offline
                    exitnuE Offline
                    exitnu
                    wrote on sidst redigeret af
                    #297

                    Zealand Pharma ansøger FDA om brug af nødpen

                    Zealand Pharma har - som planlagt - indsendt en New Drug Application-ansøgning til de amerikanske sundhedsmyndigheder, FDA, om brug af selskabets nødpen, Hypopal.

                    Det oplyser selskabet tirsdag.

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                    • exitnuE Offline
                      exitnuE Offline
                      exitnu
                      wrote on sidst redigeret af
                      #298

                      Hypopal anvendes til nødbehandling af diabetikere i forbindelse med for lavt blodsukkerniveauer.

                      Pennen er baseret på lægemiddelkandidaten Dasiglucagon, der skal bruges til behandling af episoder med for lavt blodsukker hos diabetikere - såkaldt hypoglykæmi.

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                      • exitnuE Offline
                        exitnuE Offline
                        exitnu
                        wrote on sidst redigeret af
                        #299

                        Selskabet afsluttede fase 3-forsøg i november og oplyste der at selskabet i begyndelsen af 2020 vil indsende New Drug Application-ansøgning til FDA.

                        /ritzau/FINANS

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                        • S Offline
                          S Offline
                          scorpole
                          wrote on sidst redigeret af
                          #300

                          Har vi en tidshorisont på ansøgningen, hvornår FDA skal melde noget tilbage

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                          • exitnuE Offline
                            exitnuE Offline
                            exitnu
                            wrote on sidst redigeret af
                            #301

                            6-12 måneder 🙂

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                            • S Offline
                              S Offline
                              scorpole
                              wrote on sidst redigeret af
                              #302

                              udover de 60 dage, som de til at godkende ansøgnin
                              gen

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                              • S Offline
                                S Offline
                                scorpole
                                wrote on sidst redigeret af
                                #303

                                takker exitnu

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                                • exitnuE Offline
                                  exitnuE Offline
                                  exitnu
                                  wrote on sidst redigeret af
                                  #304

                                  PDUFA Date:
                                  https://www.fool.com/knowledge-center/what-is-a-pdufa-date.aspx
                                  PDUFA drug approval dates:
                                  https://www.fdatracker.com/fda-calendar/

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                                  • exitnuE Offline
                                    exitnuE Offline
                                    exitnu
                                    wrote on sidst redigeret af
                                    #305

                                    Luk 233,60 oppe med +12,09% - endnu god dag på kontoret!

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                                    • Helge_LarsenPI-redaktørH Offline
                                      Helge_LarsenPI-redaktørH Offline
                                      Helge_LarsenPI-redaktør
                                      wrote on sidst redigeret af
                                      #306

                                      Bavarian: https://www.proinvestor.com/investornyt/658201/bavarian-nordic-offentliggor-storaktionaermeddelelse-fra-nordea-bank-abp

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