Tag Archives: semaglutide

STEP HFpEF Withdrawn; QM GLP/GIP Withdrawn; Novo Q2 ’24 Earnings

Novo Nordisk hosted its Q2 ’24 earnings call (press release; slides) and provided updates across its CVRM portfolio. Importantly, Novo disclosed it has withdrawn the STEP HFpEF sNDA and it discontinued development of its QM GLP/GIP dual agonist, among other updates. FENIX will cover Novo’s London Q2 ’24 earnings call tomorrow, August 8, 2024. Below, FENIX provides highlights and insights from the Q2 ’24 earnings call.

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ADA 2024 Key Press Releases (June 24)

On the final day of the ADA 2024 conference, nine cardiometabolic-related news items have been observed from Novo Nordisk, Adipo Therapeutics, Trinity Biotech, Alnylam, Viking, Teva, Teladoc Health, and CHMP. Below, FENIX provides context and analysis for the announcements, including thoughts on the potential FLOW label.

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Full FLOW Results at ERA; Lilly Increases Manufacturing Investment to $9B

Two cardiometabolic-related news items have been observed: the full FLOW results were presented at ERA 2024 and simultaneously published in the NEJM (press release); and Lilly announced it increased its manufacturing investment for tirzepatide API production (press release). Below, FENIX provides highlights and insights for the respective news items.

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Fractyl Preclinical Rejuva Obesity Data; Hims and Hers to Sell Compounded Semaglutide; Sanofi T1DM Screening Campaign

Three cardiometabolic-related news items have been observed: Fractyl Health presented preclinical Rejuva obesity data at DDW 2024 (view press release); Hims & Hers Health added compounded semaglutide to its virtual weight management program (view article); and Sanofi has launched a T1DM screening campaign titled, “Take the 1 Pledge,” featuring celebrity spokespeople (view website). Below, FENIX provides highlights and insights for the respective news items.

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Lilly Raises 2024 Guidance on Strong Mounjaro/Zepbound Performance; Lilly Q1 ’24 Earnings Update

Lilly hosted its Q1 ’24 earnings call (press release; slides) and provided updates across its CVRM portfolio. Of note, Lilly raised its FY revenue guidance by $2.0B to $42.4B – $43.6B, primarily due to the strong performance of Mounjaro and Zepbound. Below, FENIX provides highlights and insights from the call, including thoughts on Lilly’s strategy to develop oral formulations for tirzepatide and retatrutide.

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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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