Zealand Pharma announced positive topline results from its pediatric dasiglucagon hypoglycemia rescue trial in pediatric patients from 6 to 17 years of age. Below, FENIX provides insights on dasiglucagon in the context of the recent Lilly Baqsimi (nasal glucagon) and Xeris (subcutaneous Gvoke) FDA approvals.
Xeris Pharmaceuticals announced FDA approval of its Gvoke pre-filled syringe (PFS) and auto-injector for hypoglycemia rescue in patients 2 years of age and older. Xeris held an associated call with investors following the approval announcement. The approval comes exactly 3-months after the PDUFA delay imposed by FDA. Below, FENIX provides an in-depth Gvoke label analysis in the context of the recent approval of Lilly’s nasal glucagon, Baqsimi.
Zealand hosted its Q2 ’19 earnings call and provided updates to its clinical and commercial activities. Of note, Zealand has begun ramping up US operations with the intention to commercialize the dasiglucagon HypoPal without a partner. Below, FENIX provides highlights and insights from the call.