Tag Archives: semaglutide

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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Regeneron and Novartis Q3 ‘25 Earnings; More Novo Leadership Changes 

Three cardiometabolic-related news items have been observed: Regeneron hosted its Q3 ‘25 earnings call (press release; slides); Novartis hosted its Q3 ‘25 earnings call (press release; slides); and Tomas Landh (VP of BD) shared his impending departure from Novo Nordisk (view LinkedIn post). Below, FENIX provides highlights and insights for the respective news items.

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Novo Acquires Akero for EFX in MASH

Novo Nordisk and Akero Therapeutics announced they have entered into a definitive acquisition agreement for Novo to acquire Akero for an upfront payment of $4.7B, with a total deal value up to $5.2B. An associated call was held following the announcement (view webcast; view slides). For context, Akero’s lead asset, efruxifermin (EFX; FGF21) is currently in Ph3 development for the treatment of MASH. Below, FENIX provides highlights and insights from the deal in the context of Novo’s organizational changes. 

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Ed Cinca Rejoins Novo as SVP of US Marketing; Skye’s CB1 Ph2a Dose Suboptimal; Amgen Launches its DTP Program; Wegovy Pill Available DTP via Telehealth; Costco Sells Ozempic and Wegovy; Libre Featured on ESPN; Lilly Partners with Local Manufacturers in India

A series of cardiometabolic-related news items has been observed from Novo Nordisk, Skye Bioscience, Amgen, Abbott, and Lilly. Below, FENIX provides highlights and insights for the respective news items.

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New Orforglipron SUI Trial; Amgen VESALIUS-CV Results; EASO Recommends GLP-1RAs

Three cardiometabolic-related news items have been observed: Lilly initiated the Ph3 RESTRAIN-SUI study investigating orforglipron (QD oral GLP-1RA) in female participants with obesity or overweight and stress urinary incontinence (SUI; view CT.gov record); Amgen’s Repatha met primary endpoints for its Ph3 VESALIUS-CV trial in a primary prevention population (view press release); and EASO published a framework for obesity management, recommending semaglutide and tirzepatide as first-line AOMs (view publication). Below, FENIX provides highlights and insights for the respective news items.

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Lilly’s $6.5B Orforglipron Manufacturing Site; Novo Registers Ph2 Study of Triple Agonist; Ascletis Pharma Ph1 Results; Veru Progresses Enobosarm to Ph2b; FDA Delays T1DM Sota Decision; New O5 DTC Ad During NFL Sunday 

A series of cardiometabolic-related news items has been observed from Lilly, Novo Nordisk, Ascletis Pharma, Veru, Lexicon Pharmaceuticals, and Insulet. Below, FENIX provides highlights and insights for the respective news items.

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EASD 2025 Key Press Releases (September 17)

On the third day of EASD 2025, four key news items were observed from Lilly, FDA, and Regeneron Pharmaceuticals. Below, FENIX provides context and analysis for the announcements, including thoughts on how orforglipron could potentially be approved as early as YE 2025.

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Lilly Initiates Muvalaplin CVOT; Vivani Plans Ph1 Sema Implant Study; WHO Adds GLP-1RAs to Essential Medicines List

Three cardiometabolic-related news items have been observed: Lilly initiates the Ph3 MOVE-Lp(a) CVOT of muvalaplin in patients with elevated Lp(a) and ASCVD (view CT.gov record); Vivani Medical announced updated development plans for its semaglutide implant (view press release); and WHO updates essential medicines list to include Novo’s and Lilly’s GLP-1RAs (view article; view list). Below, FENIX provides highlights and insight for the respective news items.

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ESC 2025: Novo, Roche/Alnylam, and AstraZeneca Present New Data; Medtronic Closes in on Abbott CGM Launch; Ionis Topline Ph3 Olezarsen Results; NMPA Accepts Hengrui’s Obesity Application; Ypsomed’s SmartPilot Receives 510(k) Clearance; Biophytis Ph2 BIO101 Obesity Study; Skye Completes Ph2 Nimacimab Dosing 

A series of cardiometabolic-related news items has been observed from Novo Nordisk, Medtronic, Roche/Alnylam, AstraZeneca, Ionis Pharmaceuticals, Jiangsu Hengrui, Ypsomed, Biophytis, and Skye Bioscience. Below, FENIX provides highlights and insights for the respective news items.

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