Category Archives: Topics

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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Beta Bionics Set to IPO with $635M Valuation

Beta Bionics filed a prospectus with the SEC outlining its goal of bringing in $114.4M in an IPO (view SEC filing). For context, earlier in January 2025, Beta Bionics filed a registration statement with the SEC relating to a proposed IPO to list its common stock on Nasdaq under the “BBNX” ticker (view SEC filing). Below, FENIX provides insight into the implications of Beta Bionics’s decision.

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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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