Category Archives: Topics

Lilly Loses Counterfeit Tirzepatide Lawsuit; EMA Finds No Link Between GLP-1RAs and Suicide Ideation; Diamyd Ph3 Recruitment Update

Three cardiometabolic-related news items have been observed: Lilly loses counterfeit tirzepatide lawsuit (view article); EMA found no link between GLP-1RAs and suicide ideation (view meeting highlights); and Diamyd reached a recruitment milestone for its Ph3 DIAGNODE-3 trial in T1DM (view press release). Below, FENIX provides highlights and insights for the respective news items.

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Lipocine Ph2 Obesity Results; 89bio Enters Manufacturing Partnership

Two cardiometabolic-related news items have been observed: Lipocine announced results from a Ph2 trial evaluating LPCN 2401, an oral combination of α-tocopherol and anabolic androgen receptor agonist, in obese/overweight participants (view press release); and 89bio entered a collaboration with BiBo Biopharma Engineering to build a production facility in China to manufacture a commercial supply of pegozafermin (view 8-K SEC filing). Below, FENIX provides highlights and insights into the respective items, including thoughts on the risk 89bio is taking since pegozafermin has not yet completed clinical development.

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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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ACC 2024: Novo, Roche/Alnylam, Esperion, Novartis, and Amarin Present New Data; Novo Resubmits Catalent Acquisition Application; AZ Initiates Ph2 Balcinrenone/Dapa Trial in CKD; Silence Publishes Ph1 Lp(a) Results; Teladoc CEO Steps Down

A series of cardiometabolic-related news items have been observed from Novo Nordisk, AstraZeneca, Roche/Alnylam, Esperion, Novartis, Amarin, Silence Therapeutics, and Teladoc. 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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Zepbound Supply Constraints Observed; NeuroBo Completes Ph2a MASH Trial Enrollment; Galectin Q4 ’23 Earnings

Three cardiometabolic-related news items have been observed: Lilly’s Zepbound is reportedly facing supply constraints in the US (view article); NeuroBo announced it completed enrollment of Part 1 of the Ph2a trial evaluating DA-1241 (GPR119 agonist) for the treatment of MASH (view press release); and Galectin recently reported its Q4 ’23 earnings (view press release). Below, FENIX provides highlights and insights for the respective news items.

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