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  4. Bavarian Nordic — Marts 2021

Bavarian Nordic — Marts 2021

Planlagt Fastgjort Låst Flyttet Bavarian Nordic
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Denne tråd er blevet slettet. Kun brugere med emne behandlings privilegier kan se den.
  • J Offline
    J Offline
    Jakob440
    wrote on sidst redigeret af
    #497

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    ZEAL: Zealand Sp ADR Latest Stock Price, Analysis, News and Trading Ideas

    Get real-time Zealand Sp ADR (ZEAL) stock price, news, financials, community insights, and trading ideas. Join 10 million+ investors and traders tracking markets in real-time on Stocktwits.

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    • exitnuE Offline
      exitnuE Offline
      exitnu
      wrote on sidst redigeret af
      #498

      Zealand Pharma surges on news of FDA approval for dasiglucagon

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      • exitnuE Offline
        exitnuE Offline
        exitnu
        wrote on sidst redigeret af
        #499

        Zealand Pharma (NASDAQ:ZEAL) rose in late trading hours to end the day with a ~12.9% gain on the news that its glucagon analog dasiglucagon, with the brand name Zegalogue, won FDA approval, according to a posting on the federal agency’s website.The company hasn’t officially released a statement yet.

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        • exitnuE Offline
          exitnuE Offline
          exitnu
          wrote on sidst redigeret af
          #500

          The PDUFA was March 27 for the company’s marketing application for dasiglucagon for congenital hyperinsulinism.Zealand Pharma dropped sharply in December on the announcement of topline data from the first Phase 3 trial evaluating dasiglucagon as a treatment of Congenital Hyperinsulinism (“CHI”).

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          • exitnuE Offline
            exitnuE Offline
            exitnu
            wrote on sidst redigeret af
            #501

            Zealand Pharma surges on news of FDA approval for dasiglucagon

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            (seekingalpha.com)

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            • D Offline
              D Offline
              DevOp
              wrote on sidst redigeret af
              #502

              Og her sad man og ventede på godkendelse af HypoPal® rescue pen - så er der da basis for lidt mere i løbet af ugen 😄

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              • J Offline
                J Offline
                Jakob440
                wrote on sidst redigeret af
                #503

                Indlægssedlen lyder også fin. Har lige kort kigget den igennem.

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                • exitnuE Offline
                  exitnuE Offline
                  exitnu
                  wrote on sidst redigeret af
                  #504

                  ZEGALOGUE (dasiglucagon) injection, for subcutaneous use. Initial U.S. Approval: 2021:

                  https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/214231s000lbl.pdf

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                  • M Offline
                    M Offline
                    Munchi
                    wrote on sidst redigeret af
                    #505

                    er dette ikke hypopalpennen ? hvis nej hvad er det så ?

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                    • D Offline
                      D Offline
                      DevOp
                      wrote on sidst redigeret af
                      #506

                      Exitnu, det ser jo ud som dasi til Rescue pen mod "severe hypoglycemia" - de nævner bare ikke pennen, men de har tilsyneladende også fået godkendelse til dasi mod
                      "congenital hyperinsulinism"

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                      • J Offline
                        J Offline
                        Jakob440
                        wrote on sidst redigeret af
                        #507

                        Godkendelsen er for Dasiglucagon hypopal pennen

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                        • J Offline
                          J Offline
                          Jakob440
                          wrote on sidst redigeret af
                          #508

                          Pensionisten, det der link er forældet så det skal du bare glemme. Det var såmænd bare en bekræftelse tilbage fra maj 2020, at FDA har modtaget ansøgningen.

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                          • exitnuE Offline
                            exitnuE Offline
                            exitnu
                            wrote on sidst redigeret af
                            #509

                            "autoinjector and prefilled syringe are for subcutaneous
                            injection only"

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                            • J Offline
                              J Offline
                              Jakob440
                              wrote on sidst redigeret af
                              #510

                              DevOp, det er udelukkende en godkendelse af hypopal pennen.

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                              • D Offline
                                D Offline
                                DevOp
                                wrote on sidst redigeret af
                                #511

                                Ja, men betyder det så ikke, at "congenital hyperinsulinism" stadig mangler og endda også har PDUFA date d.27. marts?

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                                • D Offline
                                  D Offline
                                  DevOp
                                  wrote on sidst redigeret af
                                  #512

                                  havde da umiddelbart forstået det som to forskellige indikationer...

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                                  • J Offline
                                    J Offline
                                    Jakob440
                                    wrote on sidst redigeret af
                                    #513

                                    DevOp, der er ikke blevet ansøgt om godkendelse for CHI congenitial hyperinsulism i nu. De mangler det sidste fase 3 forsøg som bliver udmeldt formentlig i Q3.

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                                    • D Offline
                                      D Offline
                                      DevOp
                                      wrote on sidst redigeret af
                                      #514

                                      ok, har ikke fulgt med ift CHI - men så har de måske byttet rundt på seeking alpha linket - der nævner de netop "congenital hyperinsulinism" med PDUFA date d.27.marts

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                                      • D Offline
                                        D Offline
                                        DevOp
                                        wrote on sidst redigeret af
                                        #515

                                        Der skulle vel så have stået "severe hypoglycemia" i stedet.

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                                        • J Offline
                                          J Offline
                                          Jakob440
                                          wrote on sidst redigeret af
                                          #516

                                          Børsen har nu også meldt nyheden ud.

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