Category Archives: Glucose Monitoring

New CGM Player to Enter the Market

Allez Health announced it secured $60M in a Series A+ financing round led by Osang Healthcare Co. Ltd. and with participation from existing investors. For context, Allez (formerly called Zense-Life; view website) is an emerging biosensor venture founded by veterans in the CGM space. The company is said to be developing a CGM biosensor platform with novel sensor technology that aims to “disrupt today’s cost barrier while enhancing performance and user experience.” Stay tuned for an exclusive, in-depth FENIX interview with the Allez founders, Leif Bowman and Bob Boock. Below, FENIX provides initial insight into Allez and poses key questions about the novel sensor platform.

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Novo to Face Uphill Battle; Insulin Icodec Adcom Briefing Documents Available

Briefing documents have been posted for FDA’s Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) meeting to discuss the use of Novo Nordisk’s QW insulin icodec in T1DM patients (view here) which is being held on May 24, 2024. Below, FENIX provides an overview of FDA’s thoughts/concerns about the icodec benefit/risk profile and a prediction on how the adcom will turn out.

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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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