14 major news items were observed over the past 2 days including Provention Bio’s teplizumab, dasiglucagon pivotal data, DECLARE and EMPA-REG subanalyses, Afrezza pediatric and fixed titration data, Tandem and Insulet hybrid-closed loop data, and more. Below, FENIX provides context and analysis for the announcements.
Novo Nordisk hosted its ADA 2019 investor event immediately following the data readout from Lilly’s REWIND CVOT. Unsurprisingly, Novo compared REWIND to LEADER and SUSTAIN 6. Of note, Novo disclosed plans to initiate its high-dose semaglutide study, SUSTAIN FORTE, in Q2 ‘19. Other topics covered during the call include semaglutide LCM, commentary on Lilly’s tirzepatide, connected pen data, QW basal insulin (LAI287), and more. Below, FENIX provides insights and highlights from the call.
Medtronic hosted its annual ADA investor event and provided updates to its diabetes business including a pipeline roadmap over the next 24 months (download slides here). The event appeared to have many of the same themes from the 2018 event with a large focus on competing externally (previous FENIX insight). However, this is believed to be the first time that Medtronic has specifically called out pump and CGM competitors (Tandem and Dexcom), and for the first time, Medtronic management was wearing prototype Synergy CGMs at the event. Below, FENIX provides highlights and insights from the call.
Today, nine major news items were observed including Novo’s PIONEER 2 (vs. Jardiance) and PIONEER 4 (vs. Victoza) data readouts, new Medtronic closed-loop, and CGM pivotal trials, and more. Below, FENIX provides context and analysis for the announcements.
Today, four major new items were observed including two new Tidepool partnerships with Medtronic and Dexcom as well as updated Companion Medical InPen features and Monarch Medical’s IOB algorithm 510(k) approval. Of note, the Medtronic/Tidepool partnership is believed to be the first external partnership as part of Medtronic’s notoriously closed diabetes device ecosystem. Below, FENIX provides context and analysis for the announcements.
Today, seven major new items were observed across Sanofi, Dexcom/Companion Medical, Xeris, Senseonics, Zealand/Beta Bionics, vTv, and Adocia. Below, FENIX provides context and analysis for the announcements.
Ahead of the ADA 2019 conference start, a series of diabetes-device related press releases have been observed including Companion Medical, Glooko, DreaMed, Roche, CeQur, and Virta Health. Below, FENIX provides context and analysis for the announcements.
In the fourth and final installment of our post-AACE 2019 promotional material coverage, FENIX has conducted an analysis of diabetes devices promotional materials covering CGMs (Dexcom, Abbott, and Senseonics), pumps (Tandem and Insulet), and Connected Pens (Companion Medical). Of note, there were no promotional materials observed for any Medtronic devices. Below, FENIX provides an overview of the AACE 2019 diabetes devices promotional materials including Dexcom’s counter-messaging of the Abbott Libre CGM as well as all new Insulet Omnipod DASH promotion.
Medtronic hosted its CY Q1 ’19 (FY Q4 ’19) earnings call and provided updates to its diabetes business unit. Of note, the first trial for Medtronic’s advanced hybrid closed loop has recently been observed on CT.gov. Furthermore, Medtronic said it plans to host an investor event during ADA on June 9, 2019 where it will provide a more detailed update on its diabetes product roadmap. Below, FENIX provides highlights and insights from the call.
Zealand and Beta Bionics announced the first patients have been dosed in Beta Bionics’s iLet in-home closed-loop trial. Recall, during Zealand’s Q1 ’19 earnings call, senior management disclosed that the Ph3 pivotal dual-hormone iLet study is projected to initiate in 2020. Below, FENIX provides an overview of the trial as well as thoughts on the potential market outlook for a dual-hormone closed-loop system and impact on Zealand’s dasiglucagon business.