Category Archives: GLP-1RA

EASD 2025 Key Press Releases (September 15)

On the first day of EASD 2025, four key news items were observed from Novo Nordisk, Dexcom, Takeda, and EMA. 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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Lilly Partners for Obesity Gene Therapies and Small Molecule Drug Discovery; Novartis Acquires ASCVD Drug; Ascletis Ph1b Obesity Results

A series of cardiometabolic-related news items has been observed from Lilly/Remedium Bio/insitro, Novartis/Tourmaline Bio, and Ascletis Pharma. 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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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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Lilly Terminates Two Naperiglipron Studies; Lingo Advertisement on Reddit; Serena Williams Becomes Ro Ambassador; Another Novo Executive Steps Down; Esperion Embraces EU Recommendations for Bempedoic Acid; Daiichi Unveils Development of Fixed-Triple Combination Tablet for Lowering LDL-C

A series of cardiometabolic-related news items has been observed from Lilly, Abbott, Ro, Novo Nordisk, Esperion, and Daiichi Sankyo. Below, FENIX provides highlights and insight for the respective news items.

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Teva’s Generic Saxenda Approved by FDA; Dexcom Layoffs; FDA Accepts Proposal for MASH Surrogate Endpoint; Novo Partners with Replicate for srRNA R&D; Amylyx Prioritizes its GLP-1 Antagonist Development; Lilly Pauses Mounjaro Supply and Offers Discounts in UK

A series of cardiometabolic-related news items has been observed from Teva Pharmaceuticals, Dexcom, FDA, Novo Nordisk/Replicate Bioscience, Amylyx Pharmaceuticals, and Lilly. Below, FENIX provides highlights and insights for the respective news items.

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