On day three of ADA 2021, five cardiometabolic-related news items were observed from Novo Nordisk, Lilly, Insulet, Beta Bionics, and Tandem. Below, FENIX provides context and analysis for the announcements.
A series of cardiometabolic news items have been observed: Novo Nordisk (in partnership with Amalgam Rx) plans to expand the availability of the Dose Check basal insulin titration app in Europe and Asia (press release); Novo partners with Lumen Bioscience for oral protein manufacturing and delivery (press release); Fractyl announced the closing of a $100M Series F (press release). Below, FENIX provides highlights and insights for the respective news items.
A series of cardiometabolic news items have been observed: full results from Novo Nordisk’s Ph2 ziltivekimab were presented at ACC 2021; Sheldon Koenig was appointed as Esperion’s new President and CEO; and Neurodon is initiating IND-enabling studies for its novel T1DM therapeutic. Below, FENIX provides highlights and insights from the respective news items.
A series of diabetes-related news items have recently been observed: Novo Nordisk announced its intention to enter Ph3a development of oral semaglutide in obesity; Integrity Applications announced the appointment of notable diabetes device KOL, David Klonoff, to its Scientific Advisory Board; Roche hosted its Q1 ’21 earnings call; Poxel issued its Q1 ’21 earnings and provided an update across its business including imeglimin for T2DM and PXL770/PXL065 for NASH; and Adocia announced its Q1 ’21 earnings update. Below, FENIX provides highlights and insights for the respective news items.
A series of diabetes-related news items have been observed: a CT.gov record for Novo’s Ph3 QW insulin icodec T1DM trial (ONWARDS 6) has been observed; Dexcom announced Health Canada has authorize G6 for upper arm wear; Dario announced a virtual care initiative with MediOrbis for telehealth and remote patient monitoring; Abbott hosted its Q1 ’21 earnings call; and J&J hosted its Q1 ’21 earnings call. Below, FENIX provides highlights and insights for the respective news items.
A series of diabetes-related news items have recently been observed: mySugr announced the integration of the Novo Nordisk NovoPen 6 and NovoPen Echo Plus connected pens into the mySugr Logbook on iOS; Abbott announced a partnership with Olympic runner, Eliud Kipchoge, and the NN Running Team to support their athletic training program through the use of Abbott’s Libre Sense Glucose Sport Biosensor; and Dongwoon Anatech is seeking US and Korean regulatory approvals for a saliva-based glucose monitor, called D-SaLife. Below, FENIX provides highlights and insights for the respective news items.
A series of cardiometabolic-related news items have been observed: a CT.gov record for Novo Nordisk’s first Ph3 semaglutide NASH trial has been observed; BrightInsight announced it has raised $101M in Series C financing; Amarin announced EC approval of Vazkepa (icosapent ethyl) to reduce the risk of CV events in high-risk, statin-treated adults with elevated triglycerides (≥150 mg/dL) and either established CVD or diabetes and at least one additional CV risk factor; Glytec announced updates to its Glucommander algorithm; and Voluntis announced its FY 2020 results. Below, FENIX provides highlights and insights for the respective news items.
A series of cardiometabolic-related news items has been observed: Indigo Diabetes announced the first three participants in the GLOW early feasibility study have been implanted with Indigo’s “YANG sensor” for continuous glucose, ketone, and lactate monitoring; Gilead and Novo announced the companies have expanded their clinical collaboration in NASH following positive Ph2 POC data evaluating the combination of semaglutide+cilofexor+firsocostat; Metacrine hosted its Q4 and FY ’20 earnings call and provided development updates on MET642 and MET409 in NASH; and Cytokinetics announced a secondary analysis of GALACTIC-HF will be presented at ACC 2021 (May 15-17). Below, FENIX provides highlights and insights for the respective news items.
Novo Nordisk announced it has filed the NDA for the semaglutide 2.4mg obesity indication. Recall, Novo disclosed in October 2020 that it would be using a PRV voucher, which reduces the review to 6 months. Below, FENIX provides thoughts on the anticipated approval timeline for sema 2.4mg and readthrough to Novo’s AM833 (amylin analog) development.
Novo Nordisk hosted its Q3 ’20 earnings call (press release; slides) and provided updates across its pipeline and commercial activities, including the ongoing Rybelus launch, positive ziltivekimab Ph2b topline results, and Ph1 initiation for a novel glucose-responsive insulin. Additionally, Novo disclosed plans to use its PRV for the semaglutide 2.4mg obesity FDA submission. Below, FENIX provides highlights and thoughts from the call, including insight into a hidden importance of using the PRV for the sema 2.4mg obesity filing.