Tag Archives: Ozempic

Novo Q3 ’25 Earnings; Lowers FY 2025 Guidance…Again

Novo Nordisk hosted its Q3 ’25 earnings call (press release; slides) and provided updates across its CVRM portfolio and obesity pipeline. Of note, the company has lowered its FY 2025 sales growth guidance again from 8-14% to 8-11% due to continued underperformance of its semaglutide franchise. Recall, at the beginning of the year, Novo originally guided that FY 2025 sales growth would be in the range of 16-24% (view slide). Below, FENIX provides highlights and insights from the Q3 ’25 earnings call, including thoughts on the Metsera acquisition saga.

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Viking’s Topline AE Data Scares the Street; Medtronic Q2 ‘25 Earnings; Novo Partners for Oral Peptide Research; Rezdiffra Gains EU Marketing Authorization; UK Approves Tzield; Luna Closes Series A Funding Round; Health Canada Approves FLOW; EMA Accepts NewAmsterdam’s Obicetrapib MAA 

A series of cardiometabolic-related news items has been observed from Viking Therapeutics, Medtronic, Novo Nordisk, Madrigal Pharmaceuticals, Sanofi, Luna Health, and NewAmsterdam Pharma. 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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ADA 2025 Key Press Releases (June 23)  

On the final day of the ADA 2025 conference, six cardiometabolic-related news items have been observed from Amgen, Novo Nordisk, Lilly, Lexicon Pharmaceuticals, and Terns Pharmaceuticals. Of note, Amgen is hosting an investor call discussing the MariTide Ph2 results, and FENIX will provide updated thoughts after the team heads back from Chicago, including a benefit/risk analysis of conducting a H2H trial vs. tirzepatide. Below, FENIX provides context and analysis for the announcements.

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Obesity Spotlight: Novo’s Quest for Semaglutide Successor and Next Obesity Foundational Therapy

In the fourth installment of FENIX’s Obesity Spotlight Series, FENIX has conducted a deep dive analysis of Novo Nordisk’s obesity pipeline and strategy with a particular focus on the potential successor to semaglutide. The analysis includes an overview of Novo’s partnership/acquisition history as the company looks to fuel its next wave of obesity innovation and maintain its position in the increasingly crowded obesity market.

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Novo Q1 ‘25 Earnings

Novo Nordisk hosted its Q1 ’25 earnings call (press release; slides) and provided updates across its CVRM portfolio and Novo’s near-term obesity pipeline. Of note, Novo lowered its FY 2025 guidance due to reduced GLP-1RA market penetration as a result of compounding. Below, FENIX provides highlights and insights from the Q1 ’25 earnings call.

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