Tag Archives: cagrisema

Lilly’s Ph3 ATTAIN-MAINTAIN Results; Orforglipron Filed; Novo Files Cagrisema and Receives FDA Warning Letter; Merck to Receive CNPV; SAB BIO Pivotal Ph2b T1DM Trial; Sagimet Enters Agreement for Resmetirom

A series of cardiometabolic-related news items has been observed from Lilly, Novo Nordisk, Merck, SAB Biotherapeutics, and Sagimet Biosciences. Below, FENIX provides highlights and insights for the respective news items, including what Sagimet could be thinking vs. Madrigal.

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Lilly Cuts Zepbound Prices; Cagrisema Ph3 Pediatric Obesity Trial; Ascletis Selects Obesity Candidate; Altimmune Replaces CEO; Olazarsen Breakthrough Therapy Designation; New Ph3 Bofanglutide Study; Ikaria Registers Study for Obesity Asset Monotherapy and Combination with Tirzepatide

A series of cardiometabolic-related news items has been observed from Lilly, Novo Nordisk, Ascletis Pharma, Altimmune, Ionis Pharmaceuticals, Gan & Lee Pharmaceuticals, and Ikaria Bioscience. Below, FENIX provides highlights and insights for the respective news items.

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Obesity CNPV Analysis: Novo Changes Strategy, but Lilly Set to Win

As part of Novo and Lilly’s recent MFN deals (previous FENIX insight), both received a Commissioner’s National Priority Voucher (CNPV), potentially accelerating the review time of a product to only 1-2 months. Novo and Lilly disclosed plans to use their CNPVs for 7.2mg semaglutide and orforglipron, respectively. Below, FENIX provides thoughts on each of the CNPVs, including why Lilly is positioned to benefit the most.

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Insulet, Altimmune, Gubra, Tandem, and Structure Q3 ’25 Earnings; Cagrisema Data at ObesityWeek 2025; MetaVia and Altimmune MASH Results at AASLD 2025; New Lilly Obesity Asset 

A series of cardiometabolic-related news items has been observed from Insulet, Altimmune, Novo Nordisk, Gubra, Tandem Diabetes Care, Structure Therapeutics, MetaVia, and Lilly. Below, FENIX provides highlights and insights for the respective news items.

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Novo Q3 ’25 Earnings; Lowers FY 2025 Guidance…Again

Novo Nordisk hosted its Q3 ’25 earnings call (press release; slides) and provided updates across its CVRM portfolio and obesity pipeline. Of note, the company has lowered its FY 2025 sales growth guidance again from 8-14% to 8-11% due to continued underperformance of its semaglutide franchise. Recall, at the beginning of the year, Novo originally guided that FY 2025 sales growth would be in the range of 16-24% (view slide). Below, FENIX provides highlights and insights from the Q3 ’25 earnings call, including thoughts on the Metsera acquisition saga.

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Novo EASD 2025 R&D Event

Novo Nordisk hosted a fireside chat with Martin Holst Lange at the EASD 2025 conference and provided updates to its pipeline and strategy. Below, FENIX provides highlights and insights from the call.

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Novo Cleans Out Pipeline; Q2 ‘25 Earnings Update 

Novo Nordisk hosted its Q2 ’25 earnings call (press release; slides) and provided updates across its CVRM portfolio and near-term obesity pipeline. Recall, Novo recently promoted Mike Doustdar as its new CEO and lowered its FY 2025 sales guidance primarily due to the outsized impact of compounding on US GLP-1RA market penetration (previous FENIX insight). Importantly, Novo disclosed the discontinuation of five development programs. Below, FENIX provides highlights and insights from the Q2 ’25 earnings call, including thoughts on Novo reassessing its pipeline.

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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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