Tag Archives: DD01

Wegovy MASH Label Analysis; Ozempic Offered Through NovoCare

FDA recently approved Wegovy (2.4mg semaglutide; QW SC GLP-1RA; view label) for the treatment of noncirrhotic MASH in adults with moderate to advanced liver fibrosis (F2-F3 MASH; view press release). The accelerated approval is based on results from Part 1 of the ongoing Ph3 ESSENCE study (view publication; previous FENIX insight). Additionally, Echosens and Novo Nordisk announced they are advancing their partnership to increase awareness and early diagnosis of MASH (view press release). Below, FENIX has conducted a Wegovy label analysis, including a comparison with Madrigal’s Rezdiffra (resmetirom), the only other approved treatment for MASH.

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Lilly Expands Zepbound SDVs; Ph1 Lilly Amylin Results; D&D Ph2 Obesity Data; MBX Submits IND for Obesity Asset; June CHMP Agenda

A series of cardiometabolic-related news items have been observed from Lilly, D&D Pharmatech, MBX Biosciences, and EMA. Below, FENIX provides highlights and insights for the respective news items.

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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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Novo Ph1 GLP/GIP RA Obesity Study; Pfizer Ph1 Danuglipron Study; D&D Ph2b MASH Study; Skye Ph2 Nimacimab Obesity Trial Initiation; FDA Denies Intarcia’s T2DM Device

A series of cardiometabolic-related news items have been observed from Pfizer, Novo Nordisk, D&D Pharmatech, Skye Bioscience, and Intarcia. Below, FENIX provides highlights and insights for the respective news items.

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D&D Pharmatech Announces Positive Ph1 DD01 NAFLD Topline Results; FDA Clears NeuroBo’s IND for Ph2a DA-1241 NASH Trial; Pfizer Q1 ’23 Earnings

Three cardiometabolic-related news items have been observed: D&D Pharmatech announced positive topline results from its Ph1 SAD/MAD trial of DD01, a long-lasting dual GLP-1/glucagon receptor agonist, in overweight/obese patients with T2DM and NAFLD (view press release; CT.gov record); NeuroBo Pharmaceuticals announced FDA has cleared its IND application for DA-1241, a novel G-protein-coupled receptor 119 (GPR119) agonist (view press release); and Pfizer hosted its Q1 ’23 earnings call (view press release; slides) and provided a few GLP-1RA comments during Q&A. Below, FENIX provides highlights and insights into the respective news items.

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