Category Archives: Topics

Lilly Doubles Down on LillyDirect Program; Tandem AID Algorithm Cleared for T2DM; Compounders Sue FDA… Again; Lilly Acquires FXR Program; Terns Development Updates

A series of cardiometabolic-related news items have been observed from Lilly, Tandem Diabetes Care, the Outsourcing Facilities Association, Lilly/Organovo, and Terns Pharmaceuticals. Below, FENIX provides highlights and insights for the respective news items. 

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Lilly Stockpiles Orfoglipron; February CHMP Agenda Observed

Two cardiometabolic-related news items have been observed: Lilly has stockpiled $548M worth of orforglipron in a risky move ahead of the regulatory filing/approval (view 10-K); and the CHMP agenda (view here) for this month’s meeting (Feb 24-27) has been released. Below, FEINX provides highlights and insights for the respective news items.  

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Coming Soon: FENIX Obesity Spotlight Series

With the obesity market hot, FENIX is conducting a spotlight series throughout H1 2025 by deep diving into competitors’ portfolio approaches. The series will look to uncover key strategies that will shape the obesity market over the next 5-10 years from companies such as: Novo Nordisk, Lilly, AstraZeneca, Amgen, Boehringer Ingelheim, Roche, Merck, Regeneron, Pfizer, and others.

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New Tandem AID Algorithm Trial

Tandem initiated a trial evaluating the Tandem Freedom algorithm with its t:slim X2 pump in adults with T1DM (view CT.gov record). Existing Control-IQ technology users will use Control-IQ technology at home for a one-week run-in, then will use Tandem Freedom in a supervised hotel setting. For context, Tandem previously initiated the first feasibility trial for its Freedom algorithm in May 2024 (view CT.gov record). Below, FENIX provides highlights and insights into the trial.

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Dexcom Q4 ’24 Earnings

Dexcom hosted its Q4 ‘24 earnings call (press release; slides) and provided updates across its business. Importantly, the company provided additional details into its next-gen G8 sensor platform. Below, FENIX provides highlights and insights from the call.

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Inventiva Prioritizes Lanifibranor; TIXiMED Initiates Ph1 TIX100 Trial; Diamyd Receives Additional Financing

Three cardiometabolic-related news items have been observed: Inventiva announced plans to focus exclusively on lanifibranor development (view press release); TIXiMED initiated a Ph1 PK/PD trial for TIX100 (view CT.gov record); and Diamyd Medical announced additional funding from Breakthrough T1D (view press release). Below, FENIX provides highlights and insights for the respective news items. 

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