Category Archives: Glucose Monitoring

Eversense CGM Receives iCGM Designation

Senseonics announced its implantable Eversense CGM has been granted iCGM designation by FDA. Following the iCGM designation, the company stated it plans to advance partnership discussions with various pump manufacturers for AID integration. Below, FENIX provides brief insight into the potential impact of receiving the iCGM designation for Senseonics/Eversense.

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Dexcom Q1 ’24 Earnings

Dexcom hosted its Q1 ’24 earnings call (press release; slides) and provided updates across its business. Unsurprisingly, much of the prepared remarks and Q&A portions of the call were dedicated to Stelo and the impending launch in Summer 2024. Below, FENIX provides highlights and insights from the call.

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Novo Expands Ginkgo Partnership; Dexcom Integrates New Remote Care Platform; LIB Presents Ph3 PCSK9i Data at ACC 2024

Three cardiometabolic-related news items have been observed: Novo Nordisk expanded its partnership with Ginkgo Bioworks to improve manufacturing, including T2DM and obesity (view press release); Dexcom has partnered with MD Revolution to integrate Dexcom’s CGMs with MD’s remote care management platform (view press release); and LIB Therapeutics presented PCSK9i data at ACC 2024 (view press release). Below, FENIX provides highlights and insights for the respective news items.

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Ascletis MASH Development Updates; Biolinq Raises $58M for Intradermal Glucose Sensor; Arrowhead Initiates Ph3 Plozasiran Trials

Three cardiometabolic-related news items have been observed: Ascletis Pharma discontinues FDC MASH development in favor of other assets (view press release); Biolinq completed a $58M financing round to support the development of its intradermal glucose sensor (view press release); Arrowhead Pharmaceuticals initiated three new Ph3 trials for plozasiran: MUIR-3 (view CT.gov record) in HTG, and SHASTA-3 (view CT.gov record) and SHASTA-4 (view CT.gov record) in SHTG. Below, FENIX provides highlights and insights for the respective news items.

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Biomea and Fractyl Q4 ’23 Earnings; Glucotrack Implantable CGM Update; Costco Weight Loss Program; D&D Fast Track Designation in MASH; New Aligos Ph2a MASH Trial; Sernova Cell Pouch Updates

A series of cardiometabolic-related news items have been observed from Biomea Fusion, Fractyl Health, Glucotrack, Sesame/Costco, D&D Pharmatech, Aligos Therapeutics, and Sernova. Below, FENIX provides highlights and insights for the respective news items.

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Viking’s Momentum Continues with Ph1 Oral Obesity Win; Dexcom Faces Minor Setback in Abbott Litigation

Two cardiometabolic-related news items have been observed: Viking Therapeutics announced positive results from its Ph1 QD oral VK2735 (GLP-1/GIP dual agonist) trial and hosted an associated webcast (press release; webcast); and the US District Court for the District of Delaware found Dexcom was infringed on one of three Abbott CGM patents (view article). Below, FENIX provides highlights and insights for the respective news items.

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Icodec up for CHMP Opinion; March CHMP Agenda; Galmed Granted MASH Combo Patent; Sequel’s twiist AID Receives 510(k) Clearance

Three cardiometabolic-related news items have been observed: The CHMP agenda for this month’s meeting (March 18-21) has been released and Novo Nordisk’s insulin icodec is up for an opinion (view CHMP agenda); Galmed announced it was granted an EU patent for the combination of aramchol and resmetirom for the treatment of MASH and liver fibrosis (view press release); and Sequel Med Tech announced it received 510(k) clearance for the twiist AID system (view press release). Additionally, FENIX has provided a correction to Novo’s new Rybelsus doses based on information from its Q3 2023 earnings press release. Below, FENIX provides highlights and insights into the respective news items.

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