Tag Archives: MASH

Viking’s Topline AE Data Scares the Street; Medtronic Q2 ‘25 Earnings; Novo Partners for Oral Peptide Research; Rezdiffra Gains EU Marketing Authorization; UK Approves Tzield; Luna Closes Series A Funding Round; Health Canada Approves FLOW; EMA Accepts NewAmsterdam’s Obicetrapib MAA 

A series of cardiometabolic-related news items has been observed from Viking Therapeutics, Medtronic, Novo Nordisk, Madrigal Pharmaceuticals, Sanofi, Luna Health, and NewAmsterdam Pharma. Below, FENIX provides highlights and insights for the respective news items.

This content is for Read Less members only.
Register
Already a member? Log in here

Wegovy MASH Label Analysis; Ozempic Offered Through NovoCare

FDA recently approved Wegovy (2.4mg semaglutide; QW SC GLP-1RA; view label) for the treatment of noncirrhotic MASH in adults with moderate to advanced liver fibrosis (F2-F3 MASH; view press release). The accelerated approval is based on results from Part 1 of the ongoing Ph3 ESSENCE study (view publication; previous FENIX insight). Additionally, Echosens and Novo Nordisk announced they are advancing their partnership to increase awareness and early diagnosis of MASH (view press release). Below, FENIX has conducted a Wegovy label analysis, including a comparison with Madrigal’s Rezdiffra (resmetirom), the only other approved treatment for MASH.

This content is for Read Less members only.
Register
Already a member? Log in here

AZ to Invest $50B for US Manufacturing; Madrigal Secures $500M Credit for Pipeline Expansion 

Two cardiometabolic-related news items have been observed: AstraZeneca announced a $50B investment in US-based manufacturing facilities (view press release); and Madrigal Pharmaceuticals announced it secured $500M credit to primarily support its MASH pipeline expansion (view press release). Below, FENIX provides highlights and insights for the respective news items.

This content is for Read Less members only.
Register
Already a member? Log in here

Altimmune MASH Misstep; Novo Partners with WeightWatchers; Novartis Partners for CV Drug Discovery 

Three cardiometabolic-related news items have been observed: Altimmune announced topline Ph2b pemvidutide MASH data, which missed its co-primary endpoint (view press release); Novo announced a new collaboration with WeightWatchers to offer Wegovy through its NovoCare Pharmacy (view press release); and Novartis entered into a collaboration agreement with ProFound to discover and develop therapeutics for CVD (view press release). Below, FENIX provides highlights and insights on the respective news items.

This content is for Read Less members only.
Register
Already a member? Log in here

ADA 2025 Key Press Releases (June 20) 

On the first day of the ADA 2025 conference, seven cardiometabolic-related news items have been observed from Novo Nordisk, Tandem Diabetes Care, Beta Bionics, Ypsomed/CamDiab, Madrigal Pharmaceuticals, and Pfizer. Below, FENIX provides context and analysis for the announcements. 

This content is for Read Less members only.
Register
Already a member? Log in here

Tandem to Integrate with Abbott’s Glucose-Ketone Sensor; Insulet iOS App Integrates with Dexcom; Ypsomed and CamDiab Expand mylife Loop iOS; BI/Echosens Expand Partnership in MASH; Altimmune Initiates New Ph2 Study in ALD 

A series of cardiometabolic-related news items has been observed from Tandem Diabetes Care/Abbott, Insulet/Dexcom, Ypsomed/CamDiab, Boehringer Ingelheim/Echosens, and Altimmune. Below, FENIX provides highlights and insights for the respective news items.

This content is for Read Less members only.
Register
Already a member? Log in here

Novo Partners with Septerna for Obesity Drug Development; GSK Acquires MASH Asset from Boston Pharma; Sernova Interim Cell Pouch Results; Found Integrates with LillyDirect and NovoCare; Cytokinetics Ph3 HCM Results; Lexicon, Fractyl, and Scholar Rock Q1 ’25 Earnings 

A series of cardiometabolic-related news items has been observed from: Novo Nordisk/Septerna, GSK/Boston Pharmaceuticals, Sernova Biotherapeutics, Found, Cytokinetics, Lexicon Pharmaceuticals, Fractyl Health, and Scholar Rock. Below, FENIX provides highlights and insights for the respective news items.

This content is for Read Less members only.
Register
Already a member? Log in here

Beta Bionics Q1 ‘25 Earnings; MetaVia Presents MASH data at EASL 2025

Two cardiometabolic news items have been observed: Beta Bionics hosted its Q1 ‘25 earnings call (press release; slides); and MetaVia announced full results from its Ph2 DA-1241 study in MASH (press release; view CT.gov record). Below, FENIX provides highlights and insights for the respective news items.

This content is for Read Less members only.
Register
Already a member? Log in here

Novo Q1 ‘25 Earnings

Novo Nordisk hosted its Q1 ’25 earnings call (press release; slides) and provided updates across its CVRM portfolio and Novo’s near-term obesity pipeline. Of note, Novo lowered its FY 2025 guidance due to reduced GLP-1RA market penetration as a result of compounding. Below, FENIX provides highlights and insights from the Q1 ’25 earnings call.

This content is for Read Less members only.
Register
Already a member? Log in here