Tag Archives: Wegovy

NewSelf Gains FDA Approval for Weight Loss Program; Merck Oral PCSK9i and Vericiguat Data; Argo and Novartis Expand CV Partnership; Novartis Ph4 Leqvio Results; Biophytis Receives EMA Authorization; Gan & Lee H2H Ph3 Trial vs. Wegovy

A series of cardiometabolic-related news items has been observed from NewSelf, Merck, Novartis, Biophytis, and Gan & Lee Pharmaceuticals. Below, FENIX provides highlights and insights for the respective news items.

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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 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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Novo ADA 2025 Investor Event and Full REDEFINE 1 and 2 Results

Novo Nordisk presented results from the REDEFINE 1 and 2 cagrisema Ph3 trials at ADA 2025 (view press release); and the REDEFINE 1 (view publication) and REDEFINE 2 (view publication) results were simultaneously published in the NEJM. Following the readout, Novo hosted its ADA 2025 Investor Event and provided updates across its pipeline, including cagrisema, 7.2mg semaglutide, and amycretin. Below, FENIX provides highlights and insights from the REDEFINE presentation and investor webcast.

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Evernorth Caps Wegovy and Zepbound Costs; Saxenda Pediatric CHMP Opinion 

Two cardiometabolic-related news items have been observed: Evernorth Health Services announced a new pharmacy benefit capping the monthly OOP cost of Wegovy and Zepbound (view press release); and CHMP adopted a positive opinion for the Saxenda pediatric indication (view CHMP statement). Below, FENIX provides highlights and insights for the respective news items. 

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Novo Introduces New Wegovy Savings; Lilly’s Letter to Patients about Access; Sequel to Integrate with Abbott’s Glucose-ketone Sensor; Sernova Appoints Cell Pouch Advisory Board 

A series of cardiometabolic-related news items has been observed from Novo Nordisk, Lilly, Sequel Med Tech/Abbott, and Sernova Biotherapeutics. FENIX will cover Cigna’s announcement regarding AOM coverage (view here) in today’s upcoming blast. Below, FENIX provides highlights and insights for the respective news items.   

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