Bavarian Nordic — Marts 2021
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Mandagens aktier: Bavarian endte atter i front for positivt C25
https://www.proinvestor.com/investornyt/673356/mandagens-aktier-bavarian-endte-atter-i-front-for-positivt-c25 -
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“We are pleased by the FDA’s acceptance of the NDA for the dasiglucagon HypoPal
rescue pen, several weeks ahead of the anticipated response date. It marks an important step toward bringing a potential treatment option to people with diabetes at risk of severe hypoglycemia,” commented Adam Steensberg, Executive Vice President, Research and Development, and Chief Medical Officer at Zealand Pharma. “This represents yet another significant milestone achieved by the Zealand team. -
Jeg har fundet indlægssedlen https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/214231s000lbl.pdf
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Jeg har denne fra mit feed: (men er i tvivl)
Approval Date: 03/22/2021; Drug Name: Zegalogue, Nda #214231; Active Ingredients: DASIGLUCAGON; Company: Zealand Pharma As; Submission Status: Approval; Submission Classification: Type 1 - New Molecular Entity; Application Number: 214231
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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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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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