Category Archives: Topics

FDA Accepts AZ’s Baxdrostat NDA and MannKind’s sNDA for FUROSCIX in CHF + CKD; Medtronic Full US Launch for Abbott-Partnered CGM; Plozasiran Breakthrough Therapy Designation; New Fractyl Data; WHO Publishes GLP-1RA Guidelines

A series of cardiometabolic-related news items has been observed from AstraZeneca, MannKind, Medtronic, Arrowhead Pharmaceuticals, Fractyl Health, and the WHO. Below, FENIX provides highlights and insights for the respective news items.

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Lilly Cuts Zepbound Prices; Cagrisema Ph3 Pediatric Obesity Trial; Ascletis Selects Obesity Candidate; Altimmune Replaces CEO; Olazarsen Breakthrough Therapy Designation; New Ph3 Bofanglutide Study; Ikaria Registers Study for Obesity Asset Monotherapy and Combination with Tirzepatide

A series of cardiometabolic-related news items has been observed from Lilly, Novo Nordisk, Ascletis Pharma, Altimmune, Ionis Pharmaceuticals, Gan & Lee Pharmaceuticals, and Ikaria Bioscience. Below, FENIX provides highlights and insights for the respective news items.

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Novo Files 7.2mg Wegovy; CMS Cuts Semaglutide Prices; FDA Publishes Marketing Violation Letters

Three cardiometabolic-related news items have been observed: Novo Nordisk submitted its sNDA to FDA for high-dose (7.2mg) Wegovy in obesity (view press release); CMS announced the negotiated prices from the second round of IRA discussions, including Novo’s semaglutide (view press release; view fact sheet); and FDA published promotional activity violation letters from the OPDP (view letters). Below, FENIX provides highlights and insights for the respective news items, including the projected approval timeline for high-dose Wegovy in the US.

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Topline Amycretin Ph2 Data in T2DM; Abbott Libre 3/3+ CGM Issues

Two cardiometabolic-related news items have been observed: Novo announced topline Ph2 amycretin data in T2DM (view press release); and Abbott issued a medical correction for its Libre 3/3+ sensors in the US (view press release). Below, FENIX provides highlights and insights for the respective news items, including the potential readthrough from Novo’s amycretin data.

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Novo Misses Alzheimer’s Endpoint; Merck’s New Ph1 Asset in T2DM

Two cardiometabolic-related news items have been observed: Novo Nordisk announced topline EVOKE data for sema in Alzheimer’s (view press release); and Merck registered a Ph1 study of a new undisclosed oral coformulation in T2DM (view CT.gov record). Below, FENIX provides highlights and insights for the respective news items, including potential readthrough from EVOKE to Lilly’s plans in AD.

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Lilly and Novo Establish New Obesity Channels; Orforglipron CVOT Initiated; Lilly Ph2 Study in Chemo-Induced Nausea and Vomiting 

Three cardiometabolic-related news items have been observed: Lilly, Novo, and other partners announced direct-to-employer programs for obesity medications (view article); Lilly initiated a Ph3 CVOT for orforglipron in people with ASCVD and/or CKD (view CT.gov record); and Lilly initiated a Ph2 study of its GIP agonist for chemotherapy-induced nausea and vomiting (view CT.gov record). Below, FENIX provides highlights and insights for the respective news items.

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Mazdutide Ph3 Topline Data; Novartis 2025 Investor Day 

Two cardiometabolic-related news items have been observed: Innovent announced topline data from a Ph3 mazdutide (oxyntomodulin) study in China (view press release); and Novartis hosted its “Meet Novartis Management” investor day 2025 (view webcast; view slides). Below, FENIX provides highlights and insights for the respective news items.

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Viking Completes Ph3 Obesity Study Enrollment; FDA Clears Dexcom’s Smart Basal Feature; Modular Medical Files Patch Pump

Three cardiometabolic-related news items have been observed: Viking Therapeutics completed enrollment for its Ph3 VK2735 obesity non-T2DM study (view press release); Dexcom received FDA clearance for its Smart Basal feature (view press release) and announced plans to launch its 15 day G7 CGM in the US (view press release); and Modular Medical submitted a 510(k) for its Pivot patch pump (view press release). Below, FENIX provides highlights and insights for the respective news items.

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