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).
Beta Bionics announced it received IDE approval from FDA to initiate in-home trials of the iLet insulin-only closed loop system. According to the press release, Beta Bionics plans to initiate pivotal studies in 2019 with launch of the first commercial device in 2020.
AZ hosted their Q1 ’18 earnings call and briefly discussed their diabetes portfolio, with a particular focus on Farxiga, including H2 ‘18 readout of the DECLARE CVOT and planned H2 ’18 US filing in T1DM.
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).
During Novo’s Q1 ’18 London earnings webcast, senior management discussed potential scenarios surrounding the recently-purchased priority review voucher (PRV), including its use for either oral semaglutide or a semaglutide obesity indication. Below, FENIX provides its thoughts on how the PRV serves as insurance to a successful launch for oral semaglutide, as well as some anticipated triggers for its usage.
Novo hosted its Q1 ’18 earnings call (press release) and provided updates on its marketed and pipeline diabetes products. Of note, Novo discussed the relaunch of Tresiba based on the recent DEVOTE label update. Furthermore, Novo disclosed plans to initiate Ph2 for its QW basal insulin (LAI287) by YE ’18. Below are highlights from the call.
Biocon has reportedly received 7 Form 483 observations from FDA for its Bangalore facility. According to the report, the Bangalore facility observations are “largely procedural and aimed at continuous improvement.”
Dexcom hosted its Q1 ’18 earnings call and provided updates on its recently approved G6 CGM as well as pipeline initiatives. Of note, Dexcom has initiated a limited launch of the G6 CGM and it plans a larger rollout prior to ADA in June 2018. Below are highlights from the call.
Novo Nordisk has announced its participation in the Hypo-RESOLVE research project. FENIX has made a curious observation based on the press release, which references Stephen Gough as Novo’s “Global Chief Medical Officer in Denmark.” This position was believed to be held by Alan Moses.