Category Archives: GLP-1RA

Lexicon Sota T1DM Indication and CKM; Lilly Expands Redwire Collaboration; 89bio Initiates Ph3 ENLIGHTEN MASH Program; Fractyl Reports Preclinical Rejuva Findings; Welldoc Receives CE Mark for Bluestar

A series of cardiometabolic-related news items have been observed from Lexicon, Lilly/Redwire, 89bio, Fractyl Health, and Welldoc. Below, FENIX provides highlights and insights for the respective news items, including thoughts on how Lexicon’s sotagliflozin T1DM indication may be linked to the future continuous ketone monitor from Abbott.

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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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FLOW Topline Results; EMA Accepts Madrigal’s Resmetirom MAA; Lilly Saving Card Outage; Alnylam and Roche Report KARDIA-2 Topline Results; Dexcom, Insulet, and MannKind to Present at ATTD 2024

A series of cardiometabolic-related news items have been observed from Novo Nordisk, Madrigal, Lilly, Alnylam/Roche, Dexcom, Insulet, and MannKind. Below, FENIX provides highlights and insights on the respective news items.

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BI/Zealand Win with Positive Ph2 MASH Data; Novo Partners with Neomorph for Drug Discovery; Modular Medical Raises $10M

A series of cardiometabolic-related news items has been observed: BI and Zealand announced positive Ph2 survodutide MASH data; Neomorph announced it entered into a drug discovery partnership with Novo Nordisk for molecular glue degraders in cardiometabolic and rare diseases (view press release); and Modular Medical closed a $10M public offering (view press release). Below, FENIX provides highlights and insights into the respective news items, including thoughts on how BI/Zealand’s strategy in MASH may be different than Lilly (and Novo) due to their existing market positions in obesity. 

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