A series of cardiometabolic events has been observed from Abbott, Novartis, Biomed Industries, and Bristol Myers Squibb/Pfizer. Below, FENIX provides highlights and insights for the respective news items.
FDA announced it has published more than 200 CRLs to increase transparency. The CRLs were issued to applications submitted between 2020 and 2024, and all are for drugs that have since gained approval from the agency, a Department of Health and Human Services spokesperson told Fierce Biotech (view article). Below, FENIX provides an overview of select CRLs and brief insight into the FDA openness policy.
Abvance Therapeutics announced the closing of its strategic seed financing, which the company plans to use to support its early development programs and expand its executive/board teams. Jaivir Pall, Investment Director for diabetes at Zubi Capital, and Brent Ahrens, General Partner at Canaan Partners have been appointed to Abvance’s Board of Directors as new members. Notably, no specific figures related to the funding were disclosed. Below, FENIX provides a summary of the additional leadership changes and brief insights.
On the final day of the ADA 2025 conference, six cardiometabolic-related news items have been observed from Amgen, Novo Nordisk, Lilly, Lexicon Pharmaceuticals, and Terns Pharmaceuticals. Of note, Amgen is hosting an investor call discussing the MariTide Ph2 results, and FENIX will provide updated thoughts after the team heads back from Chicago, including a benefit/risk analysis of conducting a H2H trial vs. tirzepatide. Below, FENIX provides context and analysis for the announcements.
Lilly hosted its ADA 2025 investor call and provided updates across its obesity portfolio, including orforglipron, retatrutide, and other early pipeline assets (view webcast). Lilly separately announced the presentation of Ph3 QW insulin efsitora alfa data (view press release). Of note, Ken Custer, Lilly’s new BU head for Cardiometabolic Health (previous FENIX insight), presented to investors for the first time. Below, FENIX provides an overview of the Lilly ADA investor event.
Novo Nordisk presented results from the REDEFINE 1 and 2 cagrisema Ph3 trials at ADA 2025 (view press release); and the REDEFINE 1 (view publication) and REDEFINE 2 (view publication) results were simultaneously published in the NEJM. Following the readout, Novo hosted its ADA 2025 Investor Event and provided updates across its pipeline, including cagrisema, 7.2mg semaglutide, and amycretin. Below, FENIX provides highlights and insights from the REDEFINE presentation and investor webcast.
Beta Bionics (BB) hosted an investor event and associated webcast at ADA 2025 (view slides). As seen by FENIX, in-room attendance was convincingly robust. Below, FENIX provides a summary and insights from the event, including BB’s new patch pump named “Mint.”
On the second day of the ADA 2025 conference, six cardiometabolic-related news items have been observed from Lilly, Novo Nordisk, Vertex Pharmaceuticals, Senseonics, Medtronic, and Corxel Pharmaceuticals. Below, FENIX provides context and analysis for the announcements.
On the first day of the ADA 2025 conference, seven cardiometabolic-related news items have been observed from Novo Nordisk, Tandem Diabetes Care, Beta Bionics, Ypsomed/CamDiab, Madrigal Pharmaceuticals, and Pfizer. Below, FENIX provides context and analysis for the announcements.
A series of cardiometabolic-related news has been observed from FDA, Lilly/Verve, Metsera, Medtronic/MiniMed, and Allurion Technologies. Below, FENIX provides highlights and insights for the respective news items.