Tag Archives: semaglutide

Lilly Stockpiles Orfoglipron; February CHMP Agenda Observed

Two cardiometabolic-related news items have been observed: Lilly has stockpiled $548M worth of orforglipron in a risky move ahead of the regulatory filing/approval (view 10-K); and the CHMP agenda (view here) for this month’s meeting (Feb 24-27) has been released. Below, FEINX provides highlights and insights for the respective news items.  

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Questions Remain for Cagrisema Future; Novo Q4 ‘24 Earnings

Novo Nordisk hosted its Q4 ’24 earnings call (press release; slides) and provided updates across its CVRM portfolio, with the majority of questions revolving around the recent cagrisema readout (previous FENIX insight) and Novo’s near-term obesity pipeline. Below, FENIX provides highlights and insights from the Q4 ’24 earnings call.

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FDA Issues Warning Letter to Compounder; Lilly Discontinues HFpEF and CKD Asset; Teva Q4 ’24 Earnings

Three cardiometabolic-related news items have been observed: FDA issued a warning letter to a compounding facility over issues with its GLP-1RA production (view letter); Lilly has reportedly discontinued the development of volenrelaxin for HF and CKD (view article); and Teva Pharmaceuticals hosted its Q4 ’24 earnings (press release; slides). Below, FENIX provides highlights and insights for the respective news items.

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Akero Wins with F4 MASH Endpoint; Semaglutide + Enobosarm Combination Data; January 2025 CHMP Agenda

Three cardiometabolic-related news items have been observed: Akero Therapeutics announced positive topline results from its Ph2b SYMMETRY trial (view press release), Veru announced Ph2b semaglutide + enobosarm topline data (view press release); and the CHMP agenda for this month’s meeting (Jan 27-30) has been released (view here). Below, FENIX provides highlights and insights for the respective news items.

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Novo/Variant Partnership; Metsera Ph2a GLP-RA Data; Tandem/UVA Partnership; Biomea Icovamenib/Semaglutide Preclinical Data; Diamyd Publication; CeQur Financing Round

A series of cardiometabolic-related news items have been observed from Novo Nordisk/Variant Bio, Metsera, Tandem, Biomea Fusion, Diamyd Medical, and CeQur. FENIX will provide an overview of the updated FDA guidance (view here) on obesity and overweight medications in tomorrow’s blast. Below, FENIX provides highlights and insights for the respective news items.

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Dexcom and Oura Partnership; Novo ESSENCE Data at AASLD; Medtronic CY Q3 ’24 (FY Q2 ’25) Earnings; Silence, Esperion, NewAmsterdam, and Arrowhead Data at AHA 2024; Aligos Ph2 MASH Data; Biomea COVALENT-111 Analysis

A series of cardiometabolic-related news items have been observed from Dexcom, Novo Nordisk, Medtronic, Silence Therapeutics, Aligos Therapeutics. Biomea Fusion, Esperion, NewAmsterdam Pharma, and Arrowhead. Below, FENIX provides highlights and insights for the respective news items.

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