Tag Archives: Victoza

ATTD 2026 Key Press Releases (March 13)

On the third day of ATTD 2026, four cardiometabolic-related news items have been observed from Insulet, TIXiMED, Biocon, and Sana Biotechnology. Below, FENIX provides highlights and insights into the respective news items.

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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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Lilly Requests to Join Compounding Lawsuit; 2026 Medicare/Medicaid Obesity Proposal; Novo Petitions FDA For Compounding

Three cardiometabolic-related news items have been observed: Lilly requested to join tirzepatide compounding lawsuit (view article); CMS and HHS released the 2026 policy and technical changes to the Medicare/Medicaid programs and included proposed guidance for anti-obesity medications (view document); and Novo Nordisk has continued to petition FDA to stop compounding of Victoza (view article). Below, FENIX provides highlights and insights for the respective news items.

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JPM 2024 Day 3: TRNS, ESPR, IONS, AMRN, EMBC, and VTRS

On the third day of JPM 2024, FENIX has provided coverage of presentations by other CVRM companies, including Terns, Esperion, Ionis, Amarin, Embecta, and Viatris. Tomorrow is the final day of the JPM 2024 conference with presentations from Lexicon, Mannkind, and Xeris.

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Novo and Eleven Therapeutics Collaborate for Nucleic Acid Therapeutics; July CHMP Agenda; Madrigal Completes Resmetirom NDA Submission; Capital Health Partners with Virta Health for Rx Reverse Launch

Four cardiometabolic-related news items have been observed: Eleven Therapeutics announced a collaboration with Novo Nordisk using Eleven’s DELiveri platform to identify molecules for nucleic acid delivery (view press release); the CHMP agenda (view here) for this month’s meeting (July 17-20) has been released; Madrigal announced it completed submission of the resmetirom NDA and requested a priority review (view press release); and Capital Health announced a partnership with Virta Health to launch Rx Reverse, a clinical program designed to help manage cost of treatment for diabetes and obesity (view press release). Below, FENIX provides highlights and insights on the respective news items.

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Thoughts on Novo/Mylan (Viatris) Dismissing Their Victoza Patent Dispute; Did Viatris Just Abandon Its Generic?

On March 31, 2021, Novo Nordisk and Mylan (now Viatris) dismissed all claims from a US patent dispute over generic Victoza (view court documents). Recall, in August 2019, Novo filed a lawsuit against Mylan over Mylan’s ANDA Paragraph IV filing of a generic Victoza asserting that it was infringing upon 7 Novo patents. No further details regarding the agreement to dismiss the case were disclosed, and neither Novo nor Viatris has issued a press release. Below, FENIX provides thoughts on the litigation dismissal and how the evolving GLP-1RA market dynamics through 2025 could suggest Viatris will no longer pursue generic Victoza in the US.

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Semaglutide Positive Ph2 NASH Data; Novo Q1 ’20 Earnings Update

Novo Nordisk hosted its Q1 ’20 earnings call (press release; slides) and provided updates to its diabetes business including the ongoing launch of Rybelsus (oral semaglutide) and new Ph2 semaglutide NASH topline data. Unsurprisingly, much of the Q1 ’20 prepared remarks and Q&A were focused on NASH. Below, FENIX provides highlights from the call and additional thoughts on Novo’s PCSK9i/basal insulin hybrid approach.

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Novo Sues Mylan Over Generic Victoza

Novo has filed a lawsuit against Mylan over Mylan’s ANDA Paragraph IV filing of a generic Victoza (view court documents here). In the complaint, Novo asserts that Mylan is infringing upon 7 Novo patents. Recall, during Novo’s Q2 ’19 earnings press release, Novo disclosed it received notice from Mylan regarding the generic Victoza ANDA filing but had not yet filed suit (previous FENIX insight). Below, FENIX provides brief thoughts on the Novo lawsuit including context from Novo’s recent settlement with Teva for its generic Victoza filing.

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