Tag Archives: Jardiance

Obesity Spotlight Series: Who is the Next Sanofi?

In the twelfth installment of FENIX’s Obesity Spotlight Series, FENIX asks a provocative question: In today’s obesity market, who will be the next Sanofi? Once a diabetes powerhouse, Sanofi missed both the SGLT2i and GLP-1RA waves, and with the modern-day obesity market projected to exceed $150B by 2035 (view article), the company now finds itself on the sidelines of arguably the biggest growth opportunity in the industry’s history. This Spotlight examines how Sanofi’s past strategic mishaps transformed a potential contender into an observer and which other major pharmas may now be drifting toward the same fate.

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Novo Triple Agonist T2DM Data; BI 2026 Annual Press Conference; Pfizer Doses First Patient in VESPER-5; Merck Acquires Terns; Fractyl Q4 ’25 Earnings; Biomea FY 2025 Updates; BrightGene Ph1 Dual Agonist Data

A series of cardiometabolic-related news items has been observed by Novo Nordisk, Boehringer Ingelheim, Pfizer, Merck, Fractyl Health, Biomea Fusion, and BrightGene Bio-Medical Technology. Below, FENIX provides highlights and insights for the respective news items.

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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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Medicare Price Negotiations; Lilly Targets HCPs Promoting Compounded GLP-1RAs; Arrowhead to Advance Obesity Pipeline; New AZ Ph2 Oral GLP-1RA Obesity Trial; Rivus Ph2 HFpEF Topline Results; Zealand and Fractyl Q2 ’24 Earnings Updates

A series of cardiometabolic-related news items have been observed from CMS, Lilly, Zealand, AstraZeneca, Fractyl Health, and Rivus Pharmaceuticals. Below, FENIX provides highlights and insights for the respective news items.

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Lilly Raises 2024 Guidance on Strong Mounjaro/Zepbound Performance; Lilly Q1 ’24 Earnings Update

Lilly hosted its Q1 ’24 earnings call (press release; slides) and provided updates across its CVRM portfolio. Of note, Lilly raised its FY revenue guidance by $2.0B to $42.4B – $43.6B, primarily due to the strong performance of Mounjaro and Zepbound. Below, FENIX provides highlights and insights from the call, including thoughts on Lilly’s strategy to develop oral formulations for tirzepatide and retatrutide.

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Best Buy to Sell Dexcom G7; Gan & Lee Submits Bs-aspart and Bs-lispro MAAs; October CHMP Agenda; Tom Garner Joins Lexicon as SVP and CCO; Dario Partners with a Top Five Employee Benefits Consulting Firm; Senseonics and Ascensia Launch Eversense E3 Advertising Campaign

A series of cardiometabolic-related news items have been observed from BestBuy/Dexcom, Gan & Lee, EMA, Lexicon, Dario, and Senseonics/Ascensia. Below, FENIX provides highlights and insights into the respective news items.

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FDA Approves Jardiance for Adults with CKD; Abbott Completes Bigfoot Acquisition; Insulet Publishes “Market Opportunity & Impact of GLP-1s” Presentation; Lilly initiates Ph3 H2H Orforglipron vs. Semaglutide and New Ph3b Tirzepatide Max Dose Study in Obesity

A series of cardiometabolic-related news items have been observed from BI/Lilly, Abbott, Insulet, and Lilly. Below, FENIX provides highlights and insights into the respective news items.

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Lilly Up Big Following Q2 ’23 Results and SELECT Data Readout

Lilly hosted its Q2 ’23 earnings call (press release; slides) and provided updates across its CVRM portfolio. Of note, Mounjaro led Lilly’s new products category with WW Q2 ’23 sales reaching nearly $1B. Following the Q2 ’23 beat, increased FY 2023 guidance, and bolstered by Novo’s SELECT readout (previous FENIX insight), Lilly’s stock jumped +15% to an all-time high of ~$521/share. Unsurprisingly, Lilly also provided commentary surrounding the SELECT data readout. Below, FENIX provides highlights and insight from the call, including additional thoughts on the evolving obesity CVOT dynamic.

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Wegovy Label Update; Jardiance Receives EMPA-KIDNEY Approval in EU; Glucotrack Announces Positive Implantable CGM Data; Thane Wettig Succeeds Enrique Conterno as Fibrogen CEO

Four cardiometabolic-related news items have been observed: The Wegovy US label has been updated to include 1.7mg as a second maintenance dose in addition to the 2.4mg dose (view label); BI/Lilly announced the European Commission (EC) approved Jardiance for the treatment of adults with CKD (view press release); Glucotrack announced positive results from the feasibility study for its implantable CGM (view press release); and Fibrogen announced the resignation of Enrique Conterno, with Thane Wettig taking over as interim CEO (view press release). Below, FENIX provides highlights and insights on the respective news items, including insight into Novo’s potential rationale for adding another Wegovy maintenance dose.

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