Category Archives: Topics

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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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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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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Insulet Q4 ’23 Earnings; SELECT CHMP Decision in April?; Silence Achieves $10M Milestone Payment from AZ

Three cardiometabolic-related news items have been observed: Insulet hosted its Q4 ’23 earnings call (press release; slides); EMA reportedly intends to issue a decision for the potential use of Wegovy in treating heart disease by April (view article); and Silence Therapeutics announced it achieved a $10M milestone payment followed by the initiation of a Ph1 trial by AstraZeneca (view press release). Below, FENIX provides highlights and insights for the respective news items.

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