A series of cardiometabolic-related news items has been observed from Verdiva Bio, Zealand Pharma, MannKind, FDA, EMA, and Evogene/ELEO. Below, FENIX provides highlights and insights for the respective news items.
Recently, FDA approved Merck’s Lipfendra (enlicitide) as the first oral PCSK9i to treat adults with hypercholesterolemia, including those with HeFH (view label; view approval letter). With Merck poised to challenge established injectables such as Repatha, Praluent, and Leqvio, FENIX has conducted an in-depth Lipfendra label analysis, detailing how it compares to the market incumbents and how it may impact the LDL-C treatment landscape.
A series of cardiometabolic-related news items has been observed by Fangzhou/Novo Nordisk, CMS, Zealand Pharma, and EMA. Below, FENIX provides highlights and insights for the respective news items.
A series of cardiometabolic-related news items has been observed from Amgen, Dexcom, Zealand Pharma, Esperion Therapeutics, Senseonics, and Novo Nordisk. Below, FENIX provides highlights and insights for the respective news items.
The White House recently launched TrumpRx.gov (view website), an online platform that allows consumers to search for the lowest available cash-pay prices for their prescription medications (view image below). Importantly, the website itself is not the direct point of purchase for consumers; instead, it is a central hub that informs patients of the available out-of-pocket pricing options before redirecting them to purchase the drug by what appears to be two contrasting pathways (discussed below). Below, FENIX outlines how TrumpRx operates, its potential value creation, and why the platform may disproportionately benefit AOM manufacturers.
A series of cardiometabolic-related new items has been observed from Pfizer, Novo Nordisk, Merck, Amgen, and Zonsen PepLib Biotech/Lilly. Below, FENIX provides highlights and insights for the respective news items.
A series of cardiometabolic-related news items has been observed from Pfizer/Metsera/Novo, Amgen, Madrigal Pharmaceuticals, Vertex Pharmaceuticals, and Hims & Hers. Below, FENIX provides highlights and insights for the respective news items.
Three cardiometabolic-related news items have been observed: Lilly initiated the Ph3 RESTRAIN-SUI study investigating orforglipron (QD oral GLP-1RA) in female participants with obesity or overweight and stress urinary incontinence (SUI; view CT.gov record); Amgen’s Repatha met primary endpoints for its Ph3 VESALIUS-CV trial in a primary prevention population (view press release); and EASO published a framework for obesity management, recommending semaglutide and tirzepatide as first-line AOMs (view publication). Below, FENIX provides highlights and insights for the respective news items.
A series of cardiometabolic-related events has been observed from MannKind, Amgen, Signos, and Roche. Below, FENIX provides highlights and insights for the respective news items.
In the eighth installment of FENIX’s Obesity Spotlight Series, FENIX has conducted a deep dive analysis of Amgen’s current position in the obesity market. The analysis includes insights into Amgen’s strategy for MariTide (GLP-1 agonist/GIP antagonist) as the first QM AOM to potentially reach the market, as well as its emerging obesity pipeline.