Category Archives: Topics

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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EASD 2025 Key Press Releases (September 16) 

On the second day of EASD 2025, five key news items were observed from Novo Nordisk, Roche, Tandem Diabetes Care, and Cantoni Therapeutics. Below, FENIX provides context and analysis for the announcements.

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MIRA Acquires SKNY for CB1 Asset; Structure Initiates Ph2 Body Composition Study

Two cardiometabolic-related news items have been observed: MIRA Pharmaceuticals acquired SKNY Pharmaceuticals, including its lead CB1 inhibitor for obesity and addiction (view press release); and Structure Therapeutics initiated its Ph2 study evaluating aleniglipron on body composition in participants with obesity (view CT.gov record). Below, FENIX provides highlights and insights for the respective news items.

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Novo Restructures with Workforce Cuts; Lilly Registers New Tirzepatide and Retatrutide Ph3 MASLD Study; Tzield Approved in China

Three cardiometabolic-related events have been observed: Novo Nordisk announced a restructuring plan including ~9,000 layoffs (view press release); Lilly registered its Ph3 SYNERGY-Outcomes study of tirzepatide or retatrutide in MASLD (view CT.gov record); and Sanofi announced Tzield has been approved in China (view press release). Below, FENIX provides highlights and insights for the respective news items.

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FDA and EMA Implement Anti-Compounding Measures; Novo and Novonesis Partner for Gut Microbiome Research; Lexicon Submits Additional Sota T1DM Data; Lingo Sponsors US Open Coverage; Hansoh Initiates Ph3 T2DM Program of Olatorepatide in China

A series of cardiometabolic-related news items has been observed from FDA/EMA, Novo Nordisk/Novonesis, Lexicon Pharmaceuticals, Abbott, and Hansoh Pharmaceuticals. Below, FENIX provides highlights and insights for the respective news items.

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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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Senseonics Loses Another Partner; Skye Hosts KOL Event and Shares DIO Data; Lilly Initiates New Ph1 Trial of Obesity Asset and Ph3 Orforglipron Trial in OA; MBX Doses First Patient with MBX 4291 

A series of cardiometabolic-related news items has been observed from Senseonics/Ascensia Diabetes Care, Skye Bioscience, Lilly, and MBX Biosciences. Below, FENIX provides highlights and insights for the respective news items.

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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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