Category Archives: Other

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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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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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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