Category Archives: SGLT2i

Novo Files 7.2mg Wegovy; CMS Cuts Semaglutide Prices; FDA Publishes Marketing Violation Letters

Three cardiometabolic-related news items have been observed: Novo Nordisk submitted its sNDA to FDA for high-dose (7.2mg) Wegovy in obesity (view press release); CMS announced the negotiated prices from the second round of IRA discussions, including Novo’s semaglutide (view press release; view fact sheet); and FDA published promotional activity violation letters from the OPDP (view letters). Below, FENIX provides highlights and insights for the respective news items, including the projected approval timeline for high-dose Wegovy in the US.

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Topline Amycretin Ph2 Data in T2DM; Abbott Libre 3/3+ CGM Issues

Two cardiometabolic-related news items have been observed: Novo announced topline Ph2 amycretin data in T2DM (view press release); and Abbott issued a medical correction for its Libre 3/3+ sensors in the US (view press release). Below, FENIX provides highlights and insights for the respective news items, including the potential readthrough from Novo’s amycretin data.

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Lilly Ph3 Orfor T2DM Results; Abbott Q3 ’25 Earnings 

Two cardiometabolic events have been observed: Lilly announced topline results from the ACHIEVE-2 and ACHIEVE-5 studies of orforglipron in T2DM (view press release); and Abbott hosted its Q3 ’25 earnings call (press release; infographic). Below, FENIX provides highlights and insights for the respective news items.

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EASD 2025 Key Press Releases (September 18)

On the fourth day of EASD 2025, four key news items were observed from Roche, Novo Nordisk, and Lilly. Below, FENIX provides context and analysis for the announcements.

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FDA and EMA Implement Anti-Compounding Measures; Novo and Novonesis Partner for Gut Microbiome Research; Lexicon Submits Additional Sota T1DM Data; Lingo Sponsors US Open Coverage; Hansoh Initiates Ph3 T2DM Program of Olatorepatide in China

A series of cardiometabolic-related news items has been observed from FDA/EMA, Novo Nordisk/Novonesis, Lexicon Pharmaceuticals, Abbott, and Hansoh Pharmaceuticals. Below, FENIX provides highlights and insights for the respective news items.

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Novo’s Hiring Freeze; UK Advocates for SGLT2is for Treatment of T2DM

Two cardiometabolic-related news items have been observed: Novo Nordisk enacted a hiring freeze (view article); and NICE recommended SGLT2is as a first-line therapy for T2DM in UK (view press release). Below, FENIX provides highlights and insights for the respective news items.

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Regeneron Q2 ‘25 Earnings; Medicare + Medicaid Potentially to Cover AOMs; Leqvio Label Expansion as Monotherapy

Three cardiometabolic-related news items have been observed: Regeneron Pharmaceuticals hosted its Q2 ‘25 earnings call (press release; slides); Medicare/Medicaid announced it plans to cover AOMs as part of 5-year experiment (view article); and Novartis announced its Leqvio received FDA approval for a label expansion as a monotherapy to treat adults with hypercholesterolemia (view press release). Below, FENIX provides highlights and insights for the respective news items.

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Obesity Spotlight: How will Merck Replace Keytruda Revenue?

In the seventh installment of FENIX’s Obesity Spotlight Series, FENIX has conducted a deep dive analysis of Merck’s current position in the obesity market. The analysis includes insights into Merck’s strategy to replace Keytruda revenue and how Merck may focus its obesity efforts on a FDC approach.

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