Category Archives: Topics

December CHMP Agenda; Senseonics Eversense 365 Launch Updates; BioAge Discontinues Ph2 Obesity Trial

Three cardiometabolic-related news items have been observed: the CHMP agenda for this month’s meeting (Dec 9-12) has been released (view here); Senseonics announced commercial updates to its Eversense 365 launch (view press release); and BioAge announced the discontinuation of its Ph2 obesity trial (view press release). Below, FENIX provides highlights and insights for the respective news items.

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EC Approves Novo/Catalent Deal; Novo Cuts Insulin Business; Twiist AID Webinar; New Pfizer and Novo Obesity Studies; Lilly CDMO Agreement

A series of cardiometabolic-related news items have been observed from Novo Nordisk, Sequel Med Tech, Pfizer, and Lilly. Below, FENIX provides highlights and insights for the respective news items.

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UK Tirzepatide Rollout Plan; Lilly and Amgen Expand Manufacturing Facilities; New Novo GLP-1/GIP RA CKD and Obesity Trials; Insulet Defends US Patent from EOFlow

A series of cardiometabolic-related news items have been observed from NICE, Lilly, Amgen, Novo Nordisk, and Insulet. Below, FENIX provides highlights and insights for the respective news items.

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Zepbound Beats Wegovy in H2H Study; Novavax to Sell Manufacturing Facility to Novo; Antag $84M Series A Financing for Ph1 Obesity Trial

Three cardiometabolic-related news items have been observed: Lilly announced topline data from its SURMOUNT-5 trial where Zepbound was associated with higher weight loss compared to Wegovy (view press release); Novavax is selling a Czech manufacturing facility to Novo Nordisk (view press release); and Antag Therapeutics announced a $84M Series A financing round to support its QW SC GIPR antagonist for the treatment of obesity (view press release). Below, FENIX provides highlights and insights for the respective news items, including thoughts and implications of the H2H Zepbound vs. Wegovy data.

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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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Arrowhead CY Q3 ’24 (FY Q4 ’24) Earnings; Embecta Discontinues Patch Pump; New Medicare and Medicaid Obesity Proposal; EOFlow Wins Legal Battle in the EU

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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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Lexicon Strategic Update; Boston MASH Investor Event; Ypsomed to Manufacture Cagrisema Pens; Pep2Tango Obesity Startup; Generic Byetta FDA Approval

A series of cardiometabolic-related news items have been observed from Lexicon Pharmaceuticals, Boston Pharmaceuticals, Ypsomed, Versant Ventures, and Amneal Pharmaceuticals. Below, FENIX provides highlights and insights for the respective news items.

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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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