Lilly hosted its Q4 ’24 earnings call (press release; slides) and provided updates across its CVRM portfolio, with the majority of the commentary and questions revolving around its orforglipron data readouts and filing timeline. Below, FENIX provides highlights and insights from the Q4 ’24 earnings call.
Three cardiometabolic-related news items have been observed: FDA issued a warning letter to a compounding facility over issues with its GLP-1RA production (view letter); Lilly has reportedly discontinued the development of volenrelaxin for HF and CKD (view article); and Teva Pharmaceuticals hosted its Q4 ’24 earnings (press release; slides). Below, FENIX provides highlights and insights for the respective news items.
On the third day of JPM 2025, FENIX has provided coverage of presentations by major CVRM companies, including Insulet, Madrigal, Biomea Fusion, Ionis, and Sana Biotechnology. Separately, a series of CVRM-related news items has been observed:
On the second day of JPM 2025, FENIX has provided coverage of presentations by major CVRM companies, including Lilly, AstraZeneca, Sanofi, Novartis, Bayer, Akero, Scholar Rock, Sandoz, Merck, Teladoc, and Viatris. Of note, JPM experienced webcast issues during the 9:45 AM PT time slot. Separately, one CVRM-related news item has been observed: Dario partnered with MediOrbis for GLP-1RA solution expansion (view press release).
FDA recently approved the Zepbound label expansion to treat moderate-to-severe obstructive sleep apnea (OSA) in adults with obesity (view label; previous FENIX insight). The label expansion is based on Lilly’s Ph3 SURMOUNT-OSA trial evaluating tirzepatide in participants with OSA and obesity (view publication; previous FENIX insight). Below, FENIX has conducted an analysis of the updated Zepbound label and patient/HCP/employer websites.
Three cardiometabolic-related news items have been observed: Lilly and Thrive Global announced a partnership to implement healthy behaviors on LillyDirect (view press release); Verdiva Bio announced its launch as a cardiometabolic company (view press release); and Senseonics released its YE 2024 business update (view press release). Below, FENIX provides highlights and insights for the respective news items.
Three cardiometabolic-related news items have been observed: The Outsourcing Facilities Association (OFA) responded to Novo’s petition to add semaglutide to FDA’s Demonstrable Difficulties for Compounding Lists (DDC Lists; view document); PreEvnt announced a new non-invasive glucose monitor that uses the patient’s breath (view press release); and Novo Holdings and Lilly participated in Orbis Medicines’s €90M Series A financing for oral macrocycle drugs (view Orbis press release; view Novo Holdings press release). Below, FENIX provides highlights and insights for the respective news items.
Three cardiometabolic-related news items have been observed: Lilly requested to join tirzepatide compounding lawsuit (view article); CMS and HHS released the 2026 policy and technical changes to the Medicare/Medicaid programs and included proposed guidance for anti-obesity medications (view document); and Novo Nordisk has continued to petition FDA to stop compounding of Victoza (view article). Below, FENIX provides highlights and insights for the respective news items.
During the holiday break, a series of cardiometabolic-related news items were observed from Lilly, NICE, Dexcom/Abbott, Arrowhead Pharmaceuticals, AstraZeneca, Zealand Pharma, Biocon/Hakima, and Lexicon Pharmaceuticals. Below, FENIX provides highlights and insights for the respective news items.
Three cardiometabolic-related news items have been observed: FDA clarified the tirzepatide shortage resolution and impact on compounding pharmacies (view report); AstraZeneca initiated a Ph3 baxdrostat/dapagliflozin renal outcomes and CV mortality trial (view CT.gov record); and TIXiMED announced a $2.65M Helmsley Charitable Trust investment (view press release). Below, FENIX provides highlights and insights for the respective news items.