Category Archives: Dual/triple agonist

Roche and Sanofi Q4 ‘24 Earnings; Tectonic Interim Ph1b HFpEF Data

Three cardiometabolic-related news items have been observed: Roche (press release; slides) and Sanofi (press release; slides; infographic) hosted their respective Q4 ’24 earnings calls; and Tectonic Therapeutic announced positive interim data from its Ph1b trial evaluating TX45 (LA relaxin fusion protein; view press release). Below, FENIX provides highlights and insights for the respective news items.

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FDA Issues Warning Letter to Compounder; Lilly Discontinues HFpEF and CKD Asset; Teva Q4 ’24 Earnings

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.

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Novo Wins with Amycretin Ph1/2 Data; Another Obesity IPO; Allurion Gastric Balloon+GLP-1RA Trial

Three cardiometabolic-related news items have been observed: Novo Nordisk announced topline Ph1b/2a SC amycretin obesity results (view press release); Aardvark Therapeutics is seeking an IPO to advance its obesity pipeline (view document); and Allurion Technologies announced plans to initiate a study evaluating its gastric balloon in combination with GLP-1RA therapy (view press release). Below, FENIX provides highlights and insights for the respective news items, including thoughts on Novo’s potential move to bypass cagrisema in favor of amycretin. 

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JPM 2025 Day 2: LLY, AZN, SNY, NVS, BAY, AKRO, SRRK, SDZ, MRK, TDOC, VTRS; Dario Partners for GLP-1RA Solution Expansion

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).

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JPM 2025 Day 1: DXCM, AMGN, VKTX, PFE, ZEAL, MDT, REGN, VTX, ALNY, CYTK; Metsera Files for IPO; Fractyl REVEAL-1 Data; Ro Zepbound DTC; 89bio 2025 Outlook

On the first day of JPM 2025, FENIX has provided coverage of presentations by major CVRM companies, including Dexcom, Amgen, Viking, Pfizer, Zealand, Medtronic, Regeneron, Vertex, Alnylam, and Cytokinetics. Roche also presented at JPM 2025 but had no meaningful discussion relating to its CVRM portfolio. Additionally, a series of CVRM-related news items have been observed:

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Zepbound OSA Label and Website Analysis

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.

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FENIX Analysis: How Will Amgen Price MariTide in Obesity?

With the recent Amgen MariTide Ph2 data readout (previous FENIX insight), a natural question becomes: how will it be priced in the context of the evolving US obesity market? For context, Amgen management highlighted it is in discussions with regulators to “rapidly advance” the initiation of its Ph3 MARITIME program (view website) following the topline Ph2 readout (view CT.gov record; previous FENIX insight).

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Lilly/Thrive Partnership for LillyDirect; Verdiva Lauches as Obesity Company; Senseonics Business Updates

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.

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