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Zealand’s Dasiglucagon Filing Delayed; Positive Ph3 Dasiglucagon Topline Results
Zealand announced positive topline results for its confirmatory Ph3 hypoglycemia rescue study evaluating dasiglucagon administered via the HypoPal autoinjector. Of note, Zealand also said its FDA filing timeline has been pushed back to early 2020 (previously YE ’19) based on recruitment difficulties with its Ph3 pediatric study. Below, FENIX provides an overview of the Ph3 HypoPal topline results in the context of Zealand’s pursuit of a commercial partner as well as thoughts on the potential impact of the regulatory filing delay.