Category Archives: Topics

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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Lilly and OliX Partner in MASH; Hims & Hers Super Bowl Ad Controversy; Novartis Initiates Pelacarsen/Inclisiran Trial in Lp(a)

Three cardiometabolic-related news items have been observed: OliX Pharmaceuticals announced a partnership with Lilly in MASH (view press release); Hims & Hers received congressional scrutiny over the company’s Super Bowl ad (view article); and Novartis initiated a Ph3 pelacarsen/inclisiran Lp(a) trial (view CT.gov record). Below, FENIX provides highlights and insights for the respective news items.  

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Ozempic CKD Label and Website Analysis

FDA recently approved the Ozempic label expansion to reduce the risk of kidney disease worsening, kidney failure (end-stage kidney disease), and death due to CVD in adults with T2DM and CKD (view label). The approval is based on the Ph3b FLOW trial (view CT.gov record) which demonstrated a -24% reduction in the primary composite endpoint (previous FENIX insight). Below, FENIX has conducted an analysis of the updated Ozempic label and patient/HCP websites.

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Orforglipron Takes Center Stage; Lilly Q4 ’24 Earnings Call

Lilly hosted its Q4 ’24 earnings call (press release; slides) and provided updates across its CVRM portfolio, with the majority of the commentary and questions revolving around its orforglipron data readouts and filing timeline. Below, FENIX provides highlights and insights from the Q4 ’24 earnings call. 

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