Tag Archives: Akero Therapeutics

Pfizer Acquires Oral GLP-1RA; FDA Grants AI Drug Development Tool in MASH; Lilly Discontinues Tempo; Novo Completes Akero Acquisition; Regeneron Registers siRNA Ph2 Study in DKD; December CHMP Agenda

A series of cardiometabolic-related news items has been observed from Pfizer, FDA, Lilly, Novo Nordisk/Akero, Regeneron Pharmaceuticals, and EMA. Below, FENIX provides highlights and insights for the respective news items.

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Novo Acquires Akero for EFX in MASH

Novo Nordisk and Akero Therapeutics announced they have entered into a definitive acquisition agreement for Novo to acquire Akero for an upfront payment of $4.7B, with a total deal value up to $5.2B. An associated call was held following the announcement (view webcast; view slides). For context, Akero’s lead asset, efruxifermin (EFX; FGF21) is currently in Ph3 development for the treatment of MASH. Below, FENIX provides highlights and insights from the deal in the context of Novo’s organizational changes. 

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Insulet, Senseonics, Skye, and Biocon Q1 ‘25 Earnings; Zealand and Roche Make it Official; Akero Presents MASH Data at EASL 2025; Lilly Initiates New Ph3 Tirzepatide Study in T1DM 

A series of cardiometabolic-related news items has been observed from Insulet, Senseonics, Zealand Pharma, Akero Therapeutics, Lilly, Skye Bioscience, and Biocon. Below, FENIX provides highlights and insights for the respective news items.  

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Lilly Partners for Cardiometabolic Drug Discovery; Insulet, 89bio, Arrowhead, and Akero Q1 ’24 Earnings; Medtronic Partners with Arecor for Implantable Pump; Senseonics Partners for Remote Care Platform; Noom Launches Movement Program for People on GLP-1RAs

A series of cardiometabolic-related news items have been observed from Lilly, Insulet, Arecor/Medtronic, Senseonics/Rimidi, 89bio, Arrowhead, Akero, and Noom. 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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Structure Tx Oral GLP-1RA Ph2a Results; Akero Doses First Patients in EFX Ph3 Program

Two cardiometabolic-related news items have been observed: Structure Therapeutics announced Ph2a study results and program updates for its oral GLP-1RA (GSBR-1290) and hosted an associated webcast (view webcast; slides); and Akero Therapeutics announced the first patients have been dosed in the SYNCHRONY Ph3 program evaluating efruxifermin (EFX) in MASH (view press release). Below, FENIX provides highlights and insights for the respective news items.

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