The CT.gov record for Novo’s Ph1 stable glucagon analog study (NN9030) has been updated, and the trial is now listed as “Suspended (Evaluation of data).” Below, FENIX provides potential scenarios for the recruitment suspension.
Zealand has announced positive topline results from its Ph3 dasiglucagon immunogenicity study. Recall, in March 2018, the company reported results stating the trial met primary and secondary endpoints.
Zealand reported completion of the second Ph3 dasiglucagon pivotal trial for the treatment of severe hypoglycemia, slightly ahead of previous guidance. Results of the trial, which included 156 T1DM subjects, are now anticipated in Q3 2018.
Xeris Pharmaceuticals has filed with the SEC for a $75M IPO under the ticker XERS. Of note, the S1 IPO registration document states FDA filing of G-Pen is anticipated in Q3 ’18, which is later than previously stated by Xeris (late Q2 ’18).
Zealand hosted its Q1 ‘18 earnings call and provided updates on its diabetes portfolio including dasiglucagon. Additionally, Zealand discussed the potential of a priority review voucher (PRV) for dasiglucagon in congenital hyperinsulinism (CHI).
Zealand has announced a collaboration with Roche for the Ph3 development of Zealand’s dasiglucagon for the treatment of congenital hyperinsulinism. Below, FENIX further analyzes this scenario.
Xeris Pharmaceuticals has announced the completion of two Ph3 clinical trials (adults and pediatrics) and one human factors study for its stable glucagon (no reconstitution required). According to the press release, the company anticipates to submit an NDA filing by the end of Q2 ’18.
Ionis hosted a Q2 ’17 earnings call and provided financial information for the quarter. During the call, Akcea financial highlights and product pipeline updates were provided. Recall, Akcea closed the company’s IPO at the end of July.