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.
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.
A series of cardiometabolic-related news items have been observed from Lilly, Novo Nordisk, US Senate HELP Committee, Teladoc, and Beta Bionics. Below, FENIX provides highlights and insights for the respective news items.
FDA has requested an adcom meeting on May 24, 2024, to discuss Novo Nordisk’s QW insulin icodec (view unpublished FDA document here). Recall, Novo previously disclosed FDA extended the icodec regulatory review by three months, with a decision now anticipated in Q3 2024 (previous FENIX insight). Below, FENIX provides insight on the potential implications and reasoning for an icodec adcom, including readthrough to Lilly’s QW insulin, efistora alfa.
Hi Everyone,
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.
Four cardiometabolic-related news items have been observed from Viking Therapeutics, AstraZeneca, Sanofi, and Merck. Below, FENIX provides highlights and insights for the respective news items.
Two cardiometabolic-related news items have been observed: a recent study from Kaiser showed that approximately 3.6M overweight or obese patients with heart conditions insured under Medicare could be eligible for Wegovy (view article); and Roche hosted its Q1 ’24 earnings call (press release; slides). Below, FENIX provides highlights and insights for the respective news items.
Two cardiometabolic-related news items have been observed: Novartis hosted its Q1 ’24 earnings call (press release; slides); and Vertex announced an exclusive licensing agreement with TreeFrog Therapeutics for TreeFrog’s proprietary cell manufacturing technology (view press release). Below, FENIX provides highlights and insights for the respective news items.
Three cardiometabolic-related news items have been observed: The CHMP agenda for this month’s meeting (April 22-25) has been released and SELECT is likely up for an opinion (view CHMP agenda); Ochre announced it entered into a partnership with BI for liver disease (view press release); and Lilly announced an agreement to acquire an injectables manufacturing facility from Nexus Pharmaceuticals (view press release). Below, FENIX provides highlights and insights into the respective news items.