Category Archives: Topics

SELECT Approved by FDA

Novo Nordisk announced FDA approved the Wegovy label expansion to reduce the risk of MACE including CV death, non-fatal MI, or non-fatal stroke in adults with either overweight or obesity and established CVD. The approval is based on the SELECT CVOT which demonstrated -20% RRR in 3P-MACE for non-T2DM people with established CVD who were treated with QW 2.4mg semaglutide (previous FENIX insight). FENIX will conduct a full label analysis of the SELECT label in the coming days. In case you missed it, FENIX conducted a full SELECT results analysis in November 2023 (previous FENIX insight).

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ATTD 2024 Key Press Releases Day 1 (March 6)

On the first day of ATTD 2024, seven cardiometabolic-related news items were observed from Roche, Dexcom, Abbott, Lilly, Know Labs, Akero, and Biomea Fusion. Below, FENIX provides highlights and insights for the respective news items.

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Akero Wins with Ph2b HARMONY MASH Results; Lilly Initiates Ph3 Lp(a) CVOT; vTv Submits T1DM Study Protocol to FDA

Three cardiometabolic-related news items have been observed: Akero announced 96-week HARMONY results evaluating efruxifermin (EFX) in MASH participants with stage 2 or 3 fibrosis (view press release); Lilly initiated the first trial in its Ph3 lepodisiran Lp(a) pivotal program (ACCLAIM-Lp(a); view CT.gov record); and vTv Therapeutics announced the submission of its cadisegliatin (TTP399) Ph3 T1DM protocol to FDA (view press release). Below, FENIX provides highlights and insights for the respective news items.

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89bio Q4 ‘23 Earnings Update

89bio reported its Q4 ‘23 earnings (view press release) and provided updates on its pegozafermin MASH development program. Of note, an associated webcast call was not held. Below, FENIX provides highlights and insights from the call.

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