Category Archives: Other

Metsera Initiates Ph2b MET-097 Obesity Trial; Arrowhead Files for Ph1/2a Obesity Trial Initiation; Sanofi Invests in New Beijing Insulin Plant

Three cardiometabolic-related news items have been observed: Metsera initiated a Ph2b MET-097 (SC GLP-1RA) obesity trial (view CT.gov record); Arrowhead Pharmaceuticals filed for regulatory clearance to initiate a Ph1/2a ARO-ALK7 (RNAi) obesity trial (view press release); and Sanofi announced it invested €1B ($1.05B) for a new insulin manufacturing facility in Beijing (view article; view Chinese press release). Below, FENIX provides highlights and insights for the respective news items.

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Amgen MariTide Ph2 Topline Results; Alnylam sNDA Accepted for Vutrisiran with PRV; Novartis Investor Event

Three cardiometabolic-related news items have been observed: Amgen announced topline 52-week data from its Ph2 MariTide obesity study (view press release); Alnylam announced FDA accepted the vutrisiran sNDA for the treatment of ATTR-CM with a PDUFA date on March 25, 2025 (view press release); and Novartis recently hosted a “Meet the Management” investor day (view press release; CEO presentation; breakout slides). Below, FENIX provides highlights and insights for the respective news items, including thoughts on Amgen’s placement in the obesity treatment paradigm. 

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Diamyd Ph3 Recruitment Update

Diamyd Medical announced it has enrolled 180 patients in the Ph3 DIAGNODE-3 trial (view CT.gov record), exceeding the recruitment target set for the planned early readout in March 2026. For context, DIAGNODE-3 is evaluating the Diamyd diabetes vaccine in 330 recently diagnosed T1DM patients 12-28 years of age who carry the HLA DR3-DQ2 haplotype (previous FENIX insight). Recall, in September 2024, Diamyd announced it will pursue accelerated approval in the US (previous FENIX insight). Below, FENIX provides brief insight on the Diamyd approval timeline.

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Lilly and Laekna Obesity Partnership; Viking Ph2b MASH Data; Medtronic InPen App FDA Clearance; Omnipod 5 and FreeStyle Libre 2 Plus Integration; Flagship and Ampersand Obesity Partnership; NewAmsterdam Ph3 TANDEM CV Data

A series of cardiometabolic-related news items have been observed from Lilly, Viking, Medtronic, Insulet, Pfizer, and NewAmsterdam Pharma. Below, FENIX provides highlights and insights for the respective news items.

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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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Boston Pharmaceuticals Ph2a MASH Topline Results

Boston Pharmaceuticals announced positive topline results from its Ph2a study (view CT.gov record) evaluating efimosfermin alfa (formerly BOS-580; SC QM FGF21 analog) in participants with F2/F3 fibrosis due to MASH. Of note, results will be presented at AASLD 2024 (Nov 15-19; San Diego, CA) and the company will host an investor event to discuss the data on November 21, 2024 (view webcast). Below, FENIX provides highlights and insights for the topline results.

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