Tag Archives: Novo Nordisk

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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Novo Cleans Out Pipeline; Q2 ‘25 Earnings Update 

Novo Nordisk hosted its Q2 ’25 earnings call (press release; slides) and provided updates across its CVRM portfolio and near-term obesity pipeline. Recall, Novo recently promoted Mike Doustdar as its new CEO and lowered its FY 2025 sales guidance primarily due to the outsized impact of compounding on US GLP-1RA market penetration (previous FENIX insight). Importantly, Novo disclosed the discontinuation of five development programs. Below, FENIX provides highlights and insights from the Q2 ’25 earnings call, including thoughts on Novo reassessing its pipeline.

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Novo Sues Compounders…Again; Pfizer, Madrigal, Vertex, Corbus, and Esperion Q2 ‘25 Earnings; Innovent Receives IND clearance for Oral GLP-1RA; Vivani Data for Semaglutide Implant 

A series of cardiometabolic-related news items has been observed from Novo Nordisk, Pfizer, Madrigal, Vertex, Innovent Biologics, Corbus, Esperion, and Vivani Medical. Below, FENIX provides highlights and insights for the respective news items.

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Novo Appoints Mike Doustdar as CEO; Lowers FY ’25 Guidance

Novo Nordisk announced Mike Doustdar has been appointed as President and CEO, effective August 7, 2025. Additionally, Novo lowered its sales and operating profit guidance for 2025 (view press release). The company held an associated call to discuss the announcements (view webcast; view slides). Of note, Novo’s stock price dropped ~21% following the news. Below, FENIX provides highlights and insights on the updates.

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Novo Loses Wegovy Patent Challenge; New Ph3 Icodec Trial; TIXiMED Appoints Advisors 

Three cardiometabolic-related news items have been observed: Viatris successfully challenged Novo Nordisk’s semaglutide patent (view court filing); Novo Nordisk registered a new Ph3 study of icodec in T1DM (view CT.gov record); and TIXiMED appoints new advisors for the development of its TIX100 program (view LinkedIn post). Below, FENIX provides highlights and insights for the respective news items.

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Altimmune MASH Misstep; Novo Partners with WeightWatchers; Novartis Partners for CV Drug Discovery 

Three cardiometabolic-related news items have been observed: Altimmune announced topline Ph2b pemvidutide MASH data, which missed its co-primary endpoint (view press release); Novo announced a new collaboration with WeightWatchers to offer Wegovy through its NovoCare Pharmacy (view press release); and Novartis entered into a collaboration agreement with ProFound to discover and develop therapeutics for CVD (view press release). Below, FENIX provides highlights and insights on the respective news items.

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