Tag Archives: cagrisema

Cagrisema Gets Redefined

Novo Nordisk announced topline results from the open-label Ph3 REDEFINE-4 study evaluating 2.4mg cagrisema (QW SC GLP-1/amylin dual agonist) H2H vs. 15mg tirzepatide (QW SC GLP-1/GIP dual agonist) in patients with obesity (view CT.gov record). An associated call was held (view slides). Of note, the trial did not achieve its primary endpoint of demonstrating non-inferiority on weight loss for cagrisema compared to tirzepatide after 84 weeks. As a result, Novo’s stock is down ~15%. Additional details from the press release and call are outlined below, including FENIX’s thoughts if commercializing cagrisema still makes sense and what BD cravings may remain.

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Novo Headwinds to Persist in 2026; Q4 ’25 Earnings Updates

Novo Nordisk hosted its Q4 ’25 earnings call (view press release; view slides) and provided updates across its diabetes and obesity business. Of note, the company’s stock is down ~20% following lower than expected FY 2026 sales guidance of -5% to -13%, vs. the Street’s low-single-digit expectations (view article). Management attributed the outlook to increased incretin pricing pressure, intensifying US competition, and ex-US patent expiries. Of note, Novo will be hosting its 2026 Capital Markets Day on September 21 in London, UK. Below, FENIX provides highlights and insights from the Q4 ’25 earnings call.

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Novo Reports Topline Cagrisema T2DM Data; Additional Nimacimab Results; Medtronic Expands 780G Access; SanegeneBio Partners with Roche; NMPA Approves Sciwind’s Ecnoglutide in T2DM 

A series of cardiometabolic-related news items has been observed from Novo Nordisk, Skye Bioscience, Medtronic, SanegeneBio/Roche, and Sciwind Biosciences. Below, FENIX provides highlights and insights for the respective news items, including a hypothesis around Novo’s cagrisema strategy.

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Novo Initiates Two Cagrisema Formulation/Device Trials; Lilly Initiates Third Ph3 Eloralintide Trial; FDA Approves Zepbound Kwikpen; Roche Increases Investment for Obesity Manufacturing Site; Abbott Q4 ’25 Earnings; CORXEL Closes $287M Series D1 Funding; Sesame Partners with Novo for Wegovy Pill

A series of cardiometabolic-related news items has been observed from Novo Nordisk, Lilly, Roche, Abbott, Corxel Pharmaceuticals, and Sesame. Below, FENIX provides highlights and insights for the respective news items.

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JPM 2025 Day 2: LLY, NVO, AMGN, VKTX, AZN, MRK, IONS; Obesity Association Debuts Standards of Care for Obesity Medications

On the second day of JPM 2026, FENIX has provided coverage of presentations by major CVRM companies, including Lilly, Novo Nordisk, Amgen, Viking Therapeutics, AstraZeneca, Merck, and Ionis Pharmaceuticals. Separately, one CVRM-related news item has been observed: The Obesity Association published new standards of care for obesity medications (view press release). Below, FENIX provides insights and highlights for the guidelines.

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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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