Category Archives: GLP-1RA

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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Lilly’s Ph3 ATTAIN-2 Results Set the Stage for Obesity Global Regulatory Filings 

Lilly announced topline results from the Ph3 ATTAIN-2 study evaluating orforglipron (QD oral GLP-1RA) in patients with obesity or overweight with T2DM, demonstrating mean body reductions of up to -10.5% after 72 weeks of treatment (view CT.gov record). Recall, earlier this month, Lilly shared topline results from the Ph3 ATTAIN-1 study, which evaluated orforglipron in non-T2DM participants with overweight or obesity (previous FENIX insight). Of note, Lilly’s stock is up ~5% today following the readout. Below, FENIX provides highlights and insights from the ATTAIN-2 topline results.

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Obesity Spotlight: Is Amgen’s QM MariTide Dosing Enough?

In the eighth installment of FENIX’s Obesity Spotlight Series, FENIX has conducted a deep dive analysis of Amgen’s current position in the obesity market. The analysis includes insights into Amgen’s strategy for MariTide (GLP-1 agonist/GIP antagonist) as the first QM AOM to potentially reach the market, as well as its emerging obesity pipeline.

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Novo’s Hiring Freeze; UK Advocates for SGLT2is for Treatment of T2DM

Two cardiometabolic-related news items have been observed: Novo Nordisk enacted a hiring freeze (view article); and NICE recommended SGLT2is as a first-line therapy for T2DM in UK (view press release). Below, FENIX provides highlights and insights for the respective news items.

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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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