Two cardiometabolic events have been observed: Lilly announced topline results from the ACHIEVE-2 and ACHIEVE-5 studies of orforglipron in T2DM (view press release); and Abbott hosted its Q3 ’25 earnings call (press release; infographic). Below, FENIX provides highlights and insights for the respective news items.
In the ninth installment of FENIX’s Obesity Spotlight Series, FENIX has conducted a deep dive analysis of Lilly’s current position in the obesity market. The analysis includes insights into Lilly’s strategy to maintain a broad portfolio to stay at the top ahead of the impending wave of obesity competitors.
Kailera Therapeutics announced a $600M Series B financing, with plans to initiate its global Ph3 program of KAI-9531 (QW SC GLP-1/GIP dual agonist) by YE 2025. Kailera completed an end-of-Ph2 meeting with FDA and discussed the Ph3 program, which will evaluate KAI-9531 in adults with obesity or overweight with and without T2DM. The company is also planning a trial in adults with a BMI of 35 or higher. For context, in May 2024, Kailera acquired exclusive global rights to develop and commercialize HRS9531 from Hengrui outside of greater China as KAI-9531 (previous FENIX insight). Below, FENIX provides highlights and insights for the news item.
A series of cardiometabolic-related news items has been observed from Novo Nordisk, MannKind, Ascletis Pharma, Lilly, and EMA. Below, FENIX provides highlights and insights for the respective news items.
Three cardiometabolic-related news items have been observed: Ypsomed announced an investment of $248M for a US manufacturing site (view press release); Eccogene filed an IPO on the Hong Kong Stock Exchange (view article; view prospectus); and Lars Fruergaard Jørgensen was appointed Chair of Healthcare Denmark (view LinkedIn post; view press release). Below, FENIX provides highlights and insights for the respective news items.
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.
A series of cardiometabolic-related news items has been observed from Biomea Fusion, AstraZeneca, Ionis Pharmaceuticals, Hanmi Pharmaceuticals, Fractyl Health, and MannKind. Below, FENIX provides highlights and insights for the respective news items.
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.
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.
Three cardiometabolic-related news items have been observed: Alnylam/Roche dosed the first patient in the Ph3 ZENITH CVOT study evaluating zilebesiran in uHTN (view press release); Hanmi Pharmaceuticals filed an IND for its muscle-sparing obesity candidate (view press release); and Sagimet Biosciences dosed the first participants in its Ph1 study of denifanstat + resmetirom (view press release). Below, FENIX provides highlights and insights for the respective news items.