Category Archives: GLP-1RA + Basal

Novo Resubmits Icodec BLA; BI and Novartis Launch DTP Platforms; t:slim X2 + Control-IQ+ Now Compatible with Lyumjev

Three cardiometabolic-related news items have been observed: Novo Nordisk resubmitted the Awiqli (insulin icodec) BLA but only for adults with T2DM (view press release); Boehringer Ingelheim (view press release) and Novartis (view press release) separately announced creation of DTP platforms; and Tandem Diabetes Care announced t:slim X2 with Control-IQ+ is now compatible with Lilly’s Lyumjev (view press release). Below, FENIX provides highlights and insights for the respective news items.

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Novo ADA 2025 Investor Event and Full REDEFINE 1 and 2 Results

Novo Nordisk presented results from the REDEFINE 1 and 2 cagrisema Ph3 trials at ADA 2025 (view press release); and the REDEFINE 1 (view publication) and REDEFINE 2 (view publication) results were simultaneously published in the NEJM. Following the readout, Novo hosted its ADA 2025 Investor Event and provided updates across its pipeline, including cagrisema, 7.2mg semaglutide, and amycretin. Below, FENIX provides highlights and insights from the REDEFINE presentation and investor webcast.

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Obesity Spotlight: Novo’s Quest for Semaglutide Successor and Next Obesity Foundational Therapy

In the fourth installment of FENIX’s Obesity Spotlight Series, FENIX has conducted a deep dive analysis of Novo Nordisk’s obesity pipeline and strategy with a particular focus on the potential successor to semaglutide. The analysis includes an overview of Novo’s partnership/acquisition history as the company looks to fuel its next wave of obesity innovation and maintain its position in the increasingly crowded obesity market.

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Insulet, Senseonics, Skye, and Biocon Q1 ‘25 Earnings; Zealand and Roche Make it Official; Akero Presents MASH Data at EASL 2025; Lilly Initiates New Ph3 Tirzepatide Study in T1DM 

A series of cardiometabolic-related news items has been observed from Insulet, Senseonics, Zealand Pharma, Akero Therapeutics, Lilly, Skye Bioscience, and Biocon. Below, FENIX provides highlights and insights for the respective news items.  

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Novo Q1 ‘25 Earnings

Novo Nordisk hosted its Q1 ’25 earnings call (press release; slides) and provided updates across its CVRM portfolio and Novo’s near-term obesity pipeline. Of note, Novo lowered its FY 2025 guidance due to reduced GLP-1RA market penetration as a result of compounding. Below, FENIX provides highlights and insights from the Q1 ’25 earnings call.

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Roche is a Zeal-ot for Petrelintide

Zealand Pharma and Roche announced a licensing and collaboration deal to co-develop and co-commercialize petrelintide (amylin analog) monotherapy and in combination with CT-388 (GLP-1/GIP dual agonist; discussed below) in obesity. Of note, Zealand hosted an associated webcast (view slides). Zealand’s stock increased ~40% following the announcement. Below, FENIX provides highlights and insights for the partnership agreement, including thoughts on how Roche may have needed the petrelintide deal to save its Carmot acquisition.

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Lilly Stockpiles Orfoglipron; February CHMP Agenda Observed

Two cardiometabolic-related news items have been observed: Lilly has stockpiled $548M worth of orforglipron in a risky move ahead of the regulatory filing/approval (view 10-K); and the CHMP agenda (view here) for this month’s meeting (Feb 24-27) has been released. Below, FEINX provides highlights and insights for the respective news items.  

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Questions Remain for Cagrisema Future; Novo Q4 ‘24 Earnings

Novo Nordisk hosted its Q4 ’24 earnings call (press release; slides) and provided updates across its CVRM portfolio, with the majority of questions revolving around the recent cagrisema readout (previous FENIX insight) and Novo’s near-term obesity pipeline. Below, FENIX provides highlights and insights from the Q4 ’24 earnings call.

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