Xeris announced topline results from the fourth Ph3 trial evaluating its stable glucagon formulation for hypoglycemia rescue. This Ph3 crossover study demonstrated that Xeris’s glucagon was non-inferior to Novo’s NovoGen in terms of achieving a plasma glucose >70mg/dL or a ≥20mg/dL increase in 30 minutes following administration. Recall, Xeris recently announced that FDA requested an additional 3 months to review the company’s NDA submission with a new action date on September 10, 2019. Below, FENIX provides brief thoughts on the Ph3 crossover trial in the context of the ongoing Xeris glucagon regulatory review.

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.

Curiously, there has been no news from Lilly regarding the US regulatory status of its Locemia nasal glucagon product. Recall, during Lilly’s Q2 ’18 earnings, the company disclosed that it filed the nasal glucagon with FDA in Q2 ’18 (and July in EU). Assuming a 10-month review period, approval was projected by the end of April 2019. Below, FENIX provides thoughts on the Lilly nasal glucagon regulatory situation including the possibility that Lilly received a CRL from FDA.

Zealand and Xeris both released their respective Q4 ’18 earnings. Of note, Xeris did not have an associated call for investors. Recall, Xeris’s Gvoke glucagon rescue product PDUFA date is on June 10, 2019, and Zealand remains on track to file an NDA for its dasiglucagon HypoPal by YE ’19. Below, FENIX provides highlights and insights from the respective earnings releases.