The FDA approval of Abbott’s next-generation CGM, Libre 2, appears to be conspicuously late, which has created questions as to what the potential issue could be. Below, FENIX provides evidence and hypotheses surrounding the delayed Libre 2 US approval. See the full blast for more details on our 3 hypotheses.
Intarcia announced FDA accepted the ITCA-650 re-filing, nearly 2 years after it received a CRL. Additionally, Dexcom announced it received FDA clearance for a new G6 professional CGM. Below, FENIX provides thoughts and insights on the respective news items.
A series of diabetes-related news has come out today including Sanofi’s plan to unveil its new business strategy during an Investor Day in December. Additionally, Novo Nordisk announced a partnership with Noom for a digital obesity coaching solution, and Lifescan is engaging with Willis Towers Watson to expand access to the OneTouch Reveal Plus digital platform. Below, FENIX provides thoughts and analysis for each respective news item.
Senseonics announced it has completed enrollment for its trial evaluating the 180-day configuration of its Eversense implantable CGM. Recall, Senseonics’s partner, Roche, is already commercializing the 180-day system (Eversense XL) in Europe. Below, FENIX provides thoughts on how the move from a 90 to 180-day sensor may impact Eversense uptake in the US.
On the second day of EASD, 7 key press releases and one new clinical trial were observed across diabetes drugs and devices. Below FENIX provides insights and context from each respective announcement.
With the start of the 2019 EASD conference, a series of diabetes drug and device-related press releases have been observed including connected care partnerships between Novo/Medtronic and Sanofi/Abbott. Additionally, AstraZeneca announced that FDA granted Fast Track designation for dapagliflozin in worsening heart failure. Below FENIX insights and context from each respective announcement.
Dance Biopharm and DarioHealth recently announced a partnership to integrate data from Dance’s smart inhaler into DarioHealth’s digital health management platform. Recall, Dance is developing inhalable insulin and GLP-1RA products. Below, FENIX provides thoughts on the partnership including context from MannKind similar partnership with OneDrop for the Afrezza BluHale platform.
Livongo hosted its first earnings call following its July 2019 IPO. Senior management provided an overview of the company including its client and member growth prospects. Below, FENIX provides highlights and insights from the call including thoughts on why the Livongo stock plummeted following the company’s first earnings release.
Medtronic hosted its CY Q2 ’19 (FY Q1 ’20) earnings call and provided a brief update to its diabetes business including the projected launch of its 780G advanced hybrid closed-loop system in FY H2 ’20 (CY late 2020/early 2021). Below, FENIX provides highlights and insights from the call.
MannKind and Senseonics hosted their Q2 ’19 earnings calls and provided updates to their respective diabetes businesses. Below, FENIX provides highlights and insights from the calls.