Category Archives: Topics

Lilly and Genesis Therapeutics Collaboration; Esperion Q1 ’22 Earnings Update; Oramed’s Pivotal Ph3 Oral Insulin Trial Completes Enrollment; MySugarWatch Launches HCP-focused Ad Campaign for sugarBEAT in MIMS

A series of cardiometabolic-related news items have been observed: Genesis Therapeutics announced a strategic collaboration with Lilly; Esperion (press release; slides) hosted its Q1 ‘22 earnings call; Oramed announced the Ph3 study (ORA-D-013-1) of its oral insulin capsule (ORMD-0801) in T2DM has completed enrollment; and Nemaura Medical announced that its UK licensee, MySugarWatch, has launched a series of ads in MIMS as part of a large-scale awareness campaign for the company’s sugarBEAT non-invasive CGM. Below, FENIX provides highlights and insights for the respective new items.

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Beta Bionics Insulin-only iLet Pivotal Trial Results @ ATTD 2022; Vertex’s Ph1/2 VX-880 Trial Placed on Clinical Hold

Two cardiometabolic-related news items have recently been observed: Beta Bionics presented results from its insulin-only bionic pancreas pivotal trial at ATTD 2022 (press release); and Vertex issued a press release detailing updates to its Ph1/2 VX-880 trial, including that FDA has placed a clinical hold on the study (press release). Below, FENIX provides highlights and insights from the respective news items.

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Novo, Dexcom, AZ, Sanofi, Biocon, and Teladoc Q1 ’22 Earnings Updates

A series of cardiometabolic-related news items have been observed: Novo (press release; slides), Dexcom (press release; slides), AZ (press release; slides), Sanofi (press release; slides), Biocon (press release), and Teladoc (press release; slides) hosted their respective Q1 ’22 earnings calls. Below, FENIX provides highlights and insights from the respective earnings calls.

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Novo Reports First QW Basal Insulin Icodec Ph3 Data

Novo announced topline results from its first QW basal insulin icodec Ph3 program (ONWARDS 2) comparing icodec to degludec in 526 patients with T2DM switching from QD insulin. Data demonstrated a statistically superior 0.93% reduction in A1C with icodec vs. 0.71% reduction with degludec. Below, FENIX provides thoughts into ONWARDS 2 icodec results.

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Did Lilly Cure Obesity? SURMOUNT-1 Topline Results; Q1 ‘22 Earnings Updates

Lilly hosted its Q1 ’22 earnings call (press release; slides) and provided updates across its CVRM portfolio. Prior to the earnings call, Lilly announced highly positive topline results from the first Ph3 tirzepatide obesity study (SURMOUNT-1) which demonstrated up to 22.5% weight loss (press release). In prepared remarks, management briefly discussed other CVRM-related topics, including regulatory approvals of EMPEROR-Preserved (previous FENIX insight), the initiation of its QW insulin Ph3 program (QWINT-3; previous FENIX insight), and early termination of EMPA-KIDNEY (previous FENIX insight). Importantly, Lilly confirmed it purchased a PRV in Q1 ’22. Below are highlights and insights from the call.

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Novartis Q1 ’22 Earnings Update

Novartis hosted its Q1 ’22 earnings call (press release; slides) and provided brief updates to its CVRM business, including Entresto’s market performance and Leqvio’s commercialization. Additionally, management stated that the Sandoz strategic review remains in progress and reiterated expectations to provide an update by EOY. Below are highlights from the call.

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Abbott Q1 ’22 Earnings Update; New YouTube Video Featuring Libre 2 App

Abbott hosted its Q1 ’22 earnings call (press release; view infographic) and provided updates on its Libre business. Unsurprisingly, much of the call focused on Abbott’s COVID-19 testing and business recovery. Of note, Abbott reported that the WW Libre user base has reached ~4M users. Separately, Abbott recently posted a new Libre 2 smartphone compatibility video on the company’s FreeStyle US YouTube channel (view video). Below are diabetes-related highlights from the call as well as insights regarding Abbott’s newly posted video.

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Daprodustat NDA Accepted by FDA; Sean Saint Looks to Do It Again; April 19-22 CHMP Agenda; J&J Q1 ’22 Earnings Update

Several cardiometabolic-related news items have recently been observed: GSK announced FDA accepted the daprodustat NDA for the treatment of patients with anemia due to CKD; Sean Saint has started a new company called Luna Diabetes (view website); the CHMP agenda for this month’s meeting (April 19-22) has been released; and J&J hosted their Q1’ 22 earnings call (press release; slides). Below, FENIX provides highlights and insights for the respective new items.

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New Medtronic 780G + Lyumjev Trial; Xigduo XR DAPA-CKD sNDA approved; Galectin NASH Trial to Continue; Sciwind Initiates Ph1 Oral GLP-1RA Trial

A series of cardiometabolic-related news items have been observed: a Medtronic-sponsored study evaluating the use of Lilly’s Lyumjev in the MiniMed 780G AID system has been observed (view CT.gov record); the Xigduo XR (dapagliflozin + metformin) DAPA-CKD sNDA has recently been approved (view updated label); Galectin Therapeutics reported positive feedback from its first DSMB meeting for its Ph2b/3 NAVIGATE study evaluating belapectin in NASH (press release); and Sciwind Biosciences announced it has started dosing patients in its Ph1 MAD study evaluating the company’s investigational oral GLP-1RA (XW004; ecnoglutide) in healthy volunteers. Below, FENIX provides highlights and insights for the respective new items.

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