Category Archives: GLP-1RA

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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Finerenone in HF Filed in EU; D&D Completes MASH Trial Enrollment

Two cardiometabolic-related news items have been observed: Bayer announced the MAA finerenone submission for adults with HF and an LVEF ≥40% (view press release); and D&D Pharmatech completed enrollment of its Ph2b MASH trial (view press release). Below, FENIX provides highlights and insights for the respective news items.

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Roche and Sanofi Q4 ‘24 Earnings; Tectonic Interim Ph1b HFpEF Data

Three cardiometabolic-related news items have been observed: Roche (press release; slides) and Sanofi (press release; slides; infographic) hosted their respective Q4 ’24 earnings calls; and Tectonic Therapeutic announced positive interim data from its Ph1b trial evaluating TX45 (LA relaxin fusion protein; view press release). Below, FENIX provides highlights and insights for the respective news items.

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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 Wins with Amycretin Ph1/2 Data; Another Obesity IPO; Allurion Gastric Balloon+GLP-1RA Trial

Three cardiometabolic-related news items have been observed: Novo Nordisk announced topline Ph1b/2a SC amycretin obesity results (view press release); Aardvark Therapeutics is seeking an IPO to advance its obesity pipeline (view document); and Allurion Technologies announced plans to initiate a study evaluating its gastric balloon in combination with GLP-1RA therapy (view press release). Below, FENIX provides highlights and insights for the respective news items, including thoughts on Novo’s potential move to bypass cagrisema in favor of amycretin. 

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