Tag Archives: ESSENCE

Innovent Initiates Ph1 INHBE China-based Study in Obesity; BioLife Receives Patent for Dissolvable Obesity Medicine; Novo’s Semaglutide Approved for MASH in China

Three cardiometabolic-related news items have been observed: Innovent Biologics initiated a Ph1 FIH study of its Q3M/Q6M SC INHBE (view CT.gov record); BioLife received a US patent for its effervescent oral peptide delivery technology (view press release); and Novo Nordisk’s injectable semaglutide received approval from NMPA for the treatment of F2-F3 MASH (view press release). Below, FENIX provides highlights and insights for the respective news items.

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Novo Raises FY ’26 Guidance but Investors Appear Unimpressed; Q2 ’26 Earnings

Novo Nordisk hosted its Q2 ’26 earnings call and provided updates across its diabetes and obesity businesses (view press release; view slides). Following the increase in FY 2026 adjusted sales guidance (now 0% to -6% vs. -4% to -12%) due to increased demand across its GLP-1RA franchise, the company’s stock is up ~1.3%. The drop in stock yesterday, after releasing its Q2 ’26 business updates (previous FENIX insight), was due to US Wegovy pill sales narrowly missing analyst consensus (view article), in addition to cagrisema failing to achieve non-inferior A1C reductions vs. tirzepatide in the Ph3 REIMAGINE 4 H2H study. Separately, Novo announced it won a preliminary injunction against Ceban Ziekenhuisfarmacie B.V., ordering the company to immediately stop selling a compounded semaglutide nasal spray infringing on Novo’s IP (view press release).

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Pfizer Wins Metsera Bidding War; Lilly Partners for RNAi Drug Discovery; AZ Acquires Obesity Start-Up; Tandem’s Mobi Cleared for Android Use; Merck, Amgen, AZ, Ionis Data at AHA 2025; November CHMP Agenda 

A series of cardiometabolic-related news items have been observed from Metsera/Pfizer, Lilly, AstraZeneca, Tandem Diabetes Care, Merck, Amgen, Bayer, Ionis Pharmaceuticals, Camurus, and EMA. Below, FENIX provides highlights and insights for the respective news items.

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Wegovy MASH Label Analysis; Ozempic Offered Through NovoCare

FDA recently approved Wegovy (2.4mg semaglutide; QW SC GLP-1RA; view label) for the treatment of noncirrhotic MASH in adults with moderate to advanced liver fibrosis (F2-F3 MASH; view press release). The accelerated approval is based on results from Part 1 of the ongoing Ph3 ESSENCE study (view publication; previous FENIX insight). Additionally, Echosens and Novo Nordisk announced they are advancing their partnership to increase awareness and early diagnosis of MASH (view press release). Below, FENIX has conducted a Wegovy label analysis, including a comparison with Madrigal’s Rezdiffra (resmetirom), the only other approved treatment for MASH.

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Skye Partners for Obesity Development; May CHMP Agenda; Altimmune Initiates Ph2 Study in AUD; Zealand Appoints New CDO; Cytokinetics Presents Additional Aficamten Analyses; Ionis Ph3 Olezarsen Topline Data 

A series of cardiometabolic-related news items has been observed from Skye Bioscience, EMA, Altimmune, Zealand Pharma, Cytokinetics, and Ionis Pharmaceuticals. Below, FENIX provides highlights and insights for the respective news items.

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Novo Q1 ‘25 Earnings

Novo Nordisk hosted its Q1 ’25 earnings call (press release; slides) and provided updates across its CVRM portfolio and Novo’s near-term obesity pipeline. Of note, Novo lowered its FY 2025 guidance due to reduced GLP-1RA market penetration as a result of compounding. Below, FENIX provides highlights and insights from the Q1 ’25 earnings call.

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Dexcom and Oura Partnership; Novo ESSENCE Data at AASLD; Medtronic CY Q3 ’24 (FY Q2 ’25) Earnings; Silence, Esperion, NewAmsterdam, and Arrowhead Data at AHA 2024; Aligos Ph2 MASH Data; Biomea COVALENT-111 Analysis

A series of cardiometabolic-related news items have been observed from Dexcom, Novo Nordisk, Medtronic, Silence Therapeutics, Aligos Therapeutics. Biomea Fusion, Esperion, NewAmsterdam Pharma, and Arrowhead. Below, FENIX provides highlights and insights for the respective news items.

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