Tag Archives: verquvo

Altimmune Initiates Ph2b Pemvidutide NASH Trial; Pfizer, Esperion, and Merck Q2 ‘23 Earnings

Four cardiometabolic-related news items have been observed: Altimmune announced enrollment of the first subject in its Ph2b IMPACT trial evaluating the efficacy and safety of pemvidutide (QW GLP-1/GCG dual agonist) in NASH (view press release); and Pfizer (press release; slides), Esperion (press release; slides), and Merck (press release; slides) hosted their respective Q2 ‘23 earnings calls. Below, FENIX provides highlights and insights into the respective news items.

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Verquvo (Vericiguat) Approved by FDA; Label Analysis, Entresto and CYTK Implications

Merck and Bayer received FDA approval of vericiguat, branded as “Verquvo,” for symptomatic chronic HF (Merck press release here and Bayer press release here). Recall, vericiguat received Priority Review from FDA in July 2020 despite the modest 10% RRR in the VICTORIA CVOT primary endpoint (view NEJM publication). For context, Verquvo is the first treatment for chronic HF approved specifically for patients following a hHF or need for outpatient intravenous diuretics. Below, FENIX details its Verquvo label analysis, including the potential for counter-detail by SGLT2i manufacturers, as well as thoughts on the cumulative regulatory tailwinds for Cytokinetics’s omecamtiv.

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