Tag Archives: Ozempic

Ozempic CKD Label and Website Analysis

FDA recently approved the Ozempic label expansion to reduce the risk of kidney disease worsening, kidney failure (end-stage kidney disease), and death due to CVD in adults with T2DM and CKD (view label). The approval is based on the Ph3b FLOW trial (view CT.gov record) which demonstrated a -24% reduction in the primary composite endpoint (previous FENIX insight). Below, FENIX has conducted an analysis of the updated Ozempic label and patient/HCP websites.

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Questions Remain for Cagrisema Future; Novo Q4 ‘24 Earnings

Novo Nordisk hosted its Q4 ’24 earnings call (press release; slides) and provided updates across its CVRM portfolio, with the majority of questions revolving around the recent cagrisema readout (previous FENIX insight) and Novo’s near-term obesity pipeline. Below, FENIX provides highlights and insights from the Q4 ’24 earnings call.

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Akero Wins with F4 MASH Endpoint; Semaglutide + Enobosarm Combination Data; January 2025 CHMP Agenda

Three cardiometabolic-related news items have been observed: Akero Therapeutics announced positive topline results from its Ph2b SYMMETRY trial (view press release), Veru announced Ph2b semaglutide + enobosarm topline data (view press release); and the CHMP agenda for this month’s meeting (Jan 27-30) has been released (view here). Below, FENIX provides highlights and insights for the respective news items.

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Merck Buys Oral GLP-1RA; MetaVia Topline Ph2a MASH Data; Structure Reveals New DACRA Obesity Asset; Novo/Photys Enter Research Partnership; G&L Initiates H2H Tirzepatide Trial; EMA to Discuss Semaglutide Rare Eye Disease Association; Novo/Catalent Deal Complete

A series of cardiometabolic-related news items have been observed from Merck/Hansoh Pharma, Metavia, Structure Therapeutics, Novo Nordisk/Photys Therapeutics, Gan & Lee, Novo/EMA, and Novo/Catalent. Below, FENIX provides highlights and insights for the respective news items.

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Novo Q3 ’24 Earnings

Novo Nordisk hosted its Q3 ’24 earnings call (press release; slides) and provided updates across its CVRM portfolio, including new semaglutide PAD data. FENIX will cover Novo’s London Q3 ’24 earnings call tomorrow, November 7, 2024. Below, FENIX provides highlights and insights from the Q3 ’24 earnings call.

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Metsera Reports Positive Ph1 Obesity Topline Results; Novo CEO Testifies at Senate HELP Committee Hearing

Two cardiometabolic-related news items have been observed: Metsera announced positive topline results from its Ph1 clinical trial of MET-097, its ultra-long-acting injectable GLP-1RA (view press release); and Novo Nordisk’s CEO, Lars Fruergaard Jørgensen, testified at the Senate Committee on Health, Education, Labor, and Pensions (HELP) hearing titled, “Why Is Novo Nordisk Charging Americans with Diabetes and Obesity Outrageously High Prices for Ozempic and Wegovy?” (view broadcast here). Below, FENIX provides insight into Metsera’s first obesity data readout as well as initial thoughts on the Senate HELP committee hearing.

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STEP HFpEF Withdrawn; QM GLP/GIP Withdrawn; Novo Q2 ’24 Earnings

Novo Nordisk hosted its Q2 ’24 earnings call (press release; slides) and provided updates across its CVRM portfolio. Importantly, Novo disclosed it has withdrawn the STEP HFpEF sNDA and it discontinued development of its QM GLP/GIP dual agonist, among other updates. FENIX will cover Novo’s London Q2 ’24 earnings call tomorrow, August 8, 2024. Below, FENIX provides highlights and insights from the Q2 ’24 earnings call.

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