Category Archives: Other

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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Abbott Q4 ‘24 Earnings; Esperion KOL Event

Two cardiometabolic-related news items have been observed: Abbott hosted its Q4 ‘24 earnings call (press release; infographic) and Esperion hosted a virtual Nexletol KOL event (view slides). Below, FENIX provides highlights and insights for the respective news items.

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FDA Accepts Plozasiran NDA for FCS; Cytokinetics Opens Ph2 AMBER-HFpEF Trial Enrollment

Two cardiometabolic-related news items have been observed: Arrowhead Pharmaceuticals announced FDA accepted the plozasiran NDA for familial chylomicronemia syndrome (FCS; view press release) and Cytokinetics started enrollment in the Ph2 AMBER-HFpEF trial (view press release). Below, FENIX provides highlights and insights for the respective news items.

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JPM 2025 Day 4: SKYE, ESPR, TRNS, IVA

On the fourth and final day of JPM 2025, FENIX has provided coverage of presentations by Skye Bioscience, Esperion Therapeutics, Terns Pharmaceuticals, and Inventiva Pharma.

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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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Diamyd Type C Meeting Updates; Kardigan Launches as CV Company; Regor Topline Ph2a Results for Oral GLP-1RA

Three cardiometabolic-related news items have been observed: Diamyd provided details on the meeting minutes from its Type C meeting with FDA regarding accelerated approval of Diamyd (view press release); Kardigan announced its launch as a CV-focused company (view press release); and Regor Therapeutics announced topline Ph2a results for its oral QD GLP-1RA in obesity (view press release). Below, FENIX provides highlights and insights for the respective news items.

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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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