Tandem Diabetes Care hosted its Q1 ’20 earnings call and provided updates to its business. Of note, Tandem disclosed that projected approvals for its remote bolus mobile app and next-gen t:sport pump have been delayed due to the COVID-19 pandemic. Below, FENIX provides highlights and insights from the call.
Roche announced it is offering free access to mySugr Pro as part of an effort to improve remote diabetes management during the COVID-19 pandemic. According to Roche, free access to mySugr Pro will be granted through September 20, 2020. Below, FENIX provides brief thoughts on Roche’s COVID-19 response and how it appears to be a play for lead generation.
The CHMP agenda for this month’s meeting (April 28-30) has been released, and it includes two notable items up for CHMP opinion: Invokana/Vokanamet renal protection indication (CREDENCE) and Sanofi’s bs-aspart initial application. Of note, the April 2020 CHMP meeting agenda was just posted today despite the fact that the meeting started yesterday. Below, FENIX provides diabetes-related highlights and insights from the April 2020 CHMP agenda.
AstraZeneca hosted its Q1 ’20 earnings call and briefly discussed its diabetes business including the recent topline data readout from DAPA-CKD, which stopped early for overwhelming efficacy. Interestingly, AZ said it does not project DAPA-CKD filing acceptance until 2021. Below, FENIX provides highlights and insights from the call, including thoughts on why the DAPA-CKD submission is later than expected.
Dexcom hosted its Q1 ’20 earnings call and provided updates to its diabetes business, including a disclosure that the company had a record number of new patient starts in Q1 ’20. Separately, Senseonics announced it received conditional approval for use of Eversense implantable CGMs while patients undergo MRI procedures. Below, FENIX provides highlights and insights from the call including thoughts on Dexcom’s COVID-19 response.
Merck and Pfizer hosted their respective Q1 ’20 earnings calls and provided updates to their diabetes businesses. Importantly, Merck disclosed that the VERTIS CV outcomes trial failed to meet superiority for CV protection. Full results from VERTIS CV are scheduled to be presented during the virtual ADA conference on June 16 at 11:15 AM ET. Below, FENIX provides highlights and insights from the respective earnings calls including thoughts on the surprising VERTIS CV results.
Lexicon hosted its Q1 ’20 earnings call and provided updates to the sotagliflozin business, including plans to focus on the sotagliflozin T1DM indication rather than T2DM. Recall, in March 2020 Lexicon announced the close out of the SCORED and SOLOIST outcomes studies due to COVID-19 as well as the low near-term prospect of finding a commercialization partner (previous FENIX insight). Below, FENIX provides highlights and insights from the call.
Sanofi hosted its Q1 ’20 earnings call and provided a brief update to its diabetes business, including the official removal of efpeglenatide from Sanofi’s pipeline. Unsurprisingly, the vast majority of the call was dedicated to Sanofi’s COVID-19 response and the Dupixent performance. Below, FENIX provides highlights and insights from the call.
Adocia announced positive results of a Ph1b study of its pramlintide+human insulin fixed-ratio combination, also called M1Pram or ADO09. Adocia is planning to host a webcast (in French) on Monday, April 27 at 12pm ET to further discuss the results. Below, FENIX provides highlights of the results and insights in the context of Xeris’s pram-insulin which is currently in Ph2 development.
Lilly hosted its Q1 ’20 earnings call and provided updates to its diabetes business. Of note, Lilly disclosed that the empa T1DM program has been discontinued. Separately, AstraZeneca announced plans to evaluate Farxiga as a treatment for hospitalized COVID-19 patients who are at increased risk of complications, such as organ failure. The trial is being conducted at Saint Luke’s Mid America Heart Institute and led by Mikhail Kosiborod. Below, FENIX provides highlights and insights from the Lilly earnings call as well as thoughts on the new AZ trial.