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.
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.
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.
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.
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.
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.
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.
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.
Two cardiometabolic-related news items have been observed: Lilly published a statement about global drug cost-sharing (view here); and BioAge Labs announced it dosed the first healthy participant in its Ph1 SAD/MAD study evaluating BGE-102 (QD oral NLRP3 inhibitor; view press release). Below, FENIX provides highlights and insights for the respective news items.
Three cardiometabolic-related items have been observed: Zealand hosted its Q2 ‘25 earnings call (press release; slides); Lilly is reportedly increasing Mounjaro pricing in the UK to match EU pricing (view article); and Superluminal announced it entered into a drug discovery agreement with Lilly (view press release). Below, FENIX provides highlights and insights for the respective news items.