Today, three key news items were observed including the Forxiga DECLARE EU approval, Breakthrough Therapy Designation to Provention Bio’s Teplizumab (PRV-031) and a MannKind/ One Drop collaboration. Below, FENIX provides context and analysis for these announcements.
Tandem Diabetes Care hosted its Q2 ’19 earnings call and provided updates to its t:slim pump business. Additionally, Tandem announced that all software updates through YE 2020 will be provided free to users with in-warranty pumps. Below, FENIX provides highlights and insights from the call.
Medtronic announced it has filed a PMA with FDA seeking a non-adjunctive (insulin dosing) claim for the Guardian Sensor 3 as part of the 670G platform. The timing is consistent with Medtronic’s CGM roadmap from its 2019 ADA investor presentation. Below, FENIX provides thoughts on the filing including the curious observation that Medtronic chose to file as part of the SAP system and not the standalone Guardian Connect CGM.
Today, Biocorp and Sanofi announced they have entered into exclusive negotiations for integrating Biocorp’s connected cap device into the Sanofi connected care platform. Below, FENIX provides read-through on what the Biocorp-Sanofi deal may signal.
Beta Bionics announced the closing of a $63M Series B2 financing round 6 months after an additional $63M Series B round. According to the press release, the funds will be used to complete final product development, Ph3 clinical trials, regulatory submissions, and the commercial launch of the iLet system. Below, FENIX provides additional thoughts on Beta Bionics and the iLet system.
Livongo has filed for its IPO under the proposed ticker “LVGO”; however, the number of shares and price has not yet been decided. Recall, on March 7, 2019, it was reported by WSJ that Livongo was preparing for a 2019 IPO with a valuation >$1B. Below, FENIX provides a brief overview of key information from the S-1 filing as well as insight into the Livongo IPO including thoughts on how Livongo is under increasing pressure to drive adoption.
Consistent with Adocia’s ADA 2019 press release, a clinicaltrials.gov record has recently been observed for the company’s pramlintide + insulin (ADO09) Ph1b study. Below, FENIX provides an overview of the ADO09 Ph1b trial including thoughts on the market potential for ADO09 as a T1DM adjunctive therapy.
Biocorp announced it received CE Mark for the Mallya, a wraparound pen solution. Mallya turns any disposable or reusable insulin pen into a connected device that collects dosing information and sends it to a companion app. Below, FENIX provides insights and context to the impending Mallya launch including thoughts on how Mallya competes with Companion Medical or could be a compliment to Lifescan’s portfolio.
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.