Tag Archives: Repatha

Ascletis Doses First Patient in Ph3; Arrowhead ESC 2026 Investor Event; Cytokinetics ACACIA-HCM Primary Results; Amgen Repatha Sub-Analyses; Alnylam Vutrisiran Sub-Analysis; Lilly 52-Week Taltz + Tirzepatide Data

A series of cardiometabolic-related news items has been observed from Ascletis Pharma, Arrowhead Pharmaceuticals, Cytokinetics, Amgen, Alnylam, and Lilly. Below, FENIX provides highlights and insights for the respective news items, including a projected approval timeline for Ph3 oral AOM development.

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Lipfendra Label Analysis

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.

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Thoughts on The TrumpRx Launch: The Future Booking.com of Obesity Drugs?

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.

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New Orforglipron SUI Trial; Amgen VESALIUS-CV Results; EASO Recommends GLP-1RAs

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.

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