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
Zealand Pharma A/S - American Depositary Shares (ZEAL)
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Source: GlobeNewswire
Press Release – No. 04 / 2020 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 Pharma’s efforts to bring life changing therapies to people with diabetes 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 Copenhagen, March 31, 2020 – Zealand Pharma A/S (“Zealand”) (NASDAQ: ZEAL), a Copenhagen-based biotechnology company focused on the discovery and development of innovative peptide-based medicines, today announced that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for
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