Tandem’s stock price has broken the $40 mark (see chart below) for the first time since Medtronic became United Healthcare’s preferred in-network insulin pump provider in May 2016. Below, FENIX provides its thoughts on Tandem’s future market opportunity.
Based on the recent AZ announcement for the initiation of a Farxiga HFpEF Ph3b study, FENIX has updated its previous SGLT2i heart failure CVOT tale-of-the-tape analysis (published June 1, 2018) and projected timeline for filings and launches.
Late last week, AZ announced a new HF CVOT for Farxiga named DELIVER. Curiously enough, the news was not seen on any global newswires. Below, FENIX provides its thoughts on the trial, including the checkered past of Scott Solomon and the choice of him as PI on DELIVER.
Dexcom announced it has acquired TypeZero. Recall, TypeZero has developed a proprietary inControl algorithm for insulin dose adjustments. The acquisition is viewed as highly positive for both sides: Dexcom gains future revenue streams and IP while TypeZero investors are able to exit with a presumably attractive return. Below, FENIX provides insight into the acquisition.
Novo Nordisk has formed a strategic alliance with Evotec for the discovery and development of novel small molecule compounds for the treatment of diabetes, obesity, NASH, CVD, and diabetic kidney disease. The partnership with Evotec is Novo’s 5th external R&D collaboration since the start of 2018. Financial terms of the agreement were not disclosed. Below, FENIX provides insight into Novo’s ongoing efforts to build up its early stage pipeline in adjacent therapy areas to diabetes via external partnerships.
Medtronic hosted its CY Q2 ’18 (FY Q1 ’19) earnings (press release) and provided a brief update to its diabetes business unit. Below are highlights from the call.
Novo announced positive top-line results from PIONEER 5 demonstrating superiority in A1C and weight loss at 26-weeks for 14mg oral semaglutide vs. placebo in T2DM patients with moderate renal impairment. Below is a table representing all of the PIONEER data released thus far for oral semaglutide including PIONEER 1, 2, 3, 4, 5 and 7. FENIX also provides insights on the oral semaglutide development program, SGLT2i eGFR comparison, and a new Ph1 oral sema tablet bioequivalence study.
Novo announced (press release) the acquisition of Ziylo, a small incubator company based out of the University of Bristol developing synthetic glucose binding molecules. The purchase of Ziylo aligns with Novo’s strategic goal of developing glucose responsive insulin.
Xeris, Tandem, and Voluntis have announced news related to their respective diabetes business units. Below, FENIX has provided a summary of these updates, the most interesting of which is from Xeris.
Novo Nordisk’s Tresiba PI was updated in the Drugs@FDA database on August 14, 2018, to reflect changes in the safety outcomes related to immunogenicity.