Tag Archives: MASH

EASD 2025 Key Press Releases (September 18)

On the fourth day of EASD 2025, four key news items were observed from Roche, Novo Nordisk, and Lilly. Below, FENIX provides context and analysis for the announcements.

About The Author

Matthew Maryniak

|
President of Fenix Group International

Matthew has been a thought leader in the high-growth therapeutic areas of diabetes and cardiovascular medicine since 2006, making regular attendance at large and small CV/met scientific meetings and an architect of novel methods for assessing market opportunities. He has over a decade of experience in leading CV/met consulting engagements, is a published author in PM360 and Diabetes Technology & Therapeutics, and has been quoted in The Pink Sheet on anti-thrombotics.

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Teva’s Generic Saxenda Approved by FDA; Dexcom Layoffs; FDA Accepts Proposal for MASH Surrogate Endpoint; Novo Partners with Replicate for srRNA R&D; Amylyx Prioritizes its GLP-1 Antagonist Development; Lilly Pauses Mounjaro Supply and Offers Discounts in UK

A series of cardiometabolic-related news items has been observed from Teva Pharmaceuticals, Dexcom, FDA, Novo Nordisk/Replicate Bioscience, Amylyx Pharmaceuticals, and Lilly. Below, FENIX provides highlights and insights for the respective news items.

About The Author

Matthew Maryniak

|
President of Fenix Group International

Matthew has been a thought leader in the high-growth therapeutic areas of diabetes and cardiovascular medicine since 2006, making regular attendance at large and small CV/met scientific meetings and an architect of novel methods for assessing market opportunities. He has over a decade of experience in leading CV/met consulting engagements, is a published author in PM360 and Diabetes Technology & Therapeutics, and has been quoted in The Pink Sheet on anti-thrombotics.

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Purchase Blast$599.00

You can read the article’s full content online after purchase.

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.

About The Author

Matthew Maryniak

|
President of Fenix Group International

Matthew has been a thought leader in the high-growth therapeutic areas of diabetes and cardiovascular medicine since 2006, making regular attendance at large and small CV/met scientific meetings and an architect of novel methods for assessing market opportunities. He has over a decade of experience in leading CV/met consulting engagements, is a published author in PM360 and Diabetes Technology & Therapeutics, and has been quoted in The Pink Sheet on anti-thrombotics.

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Purchase Blast$599.00

You can read the article’s full content online after purchase.

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.

About The Author

Matthew Maryniak

|
President of Fenix Group International

Matthew has been a thought leader in the high-growth therapeutic areas of diabetes and cardiovascular medicine since 2006, making regular attendance at large and small CV/met scientific meetings and an architect of novel methods for assessing market opportunities. He has over a decade of experience in leading CV/met consulting engagements, is a published author in PM360 and Diabetes Technology & Therapeutics, and has been quoted in The Pink Sheet on anti-thrombotics.

If you receive our email blasts, you already have an account.

Purchase Blast$599.00

You can read the article’s full content online after purchase.

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.

About The Author

Matthew Maryniak

|
President of Fenix Group International

Matthew has been a thought leader in the high-growth therapeutic areas of diabetes and cardiovascular medicine since 2006, making regular attendance at large and small CV/met scientific meetings and an architect of novel methods for assessing market opportunities. He has over a decade of experience in leading CV/met consulting engagements, is a published author in PM360 and Diabetes Technology & Therapeutics, and has been quoted in The Pink Sheet on anti-thrombotics.

If you receive our email blasts, you already have an account.

Purchase Blast$599.00

You can read the article’s full content online after purchase.

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.

About The Author

Matthew Maryniak

|
President of Fenix Group International

Matthew has been a thought leader in the high-growth therapeutic areas of diabetes and cardiovascular medicine since 2006, making regular attendance at large and small CV/met scientific meetings and an architect of novel methods for assessing market opportunities. He has over a decade of experience in leading CV/met consulting engagements, is a published author in PM360 and Diabetes Technology & Therapeutics, and has been quoted in The Pink Sheet on anti-thrombotics.

If you receive our email blasts, you already have an account.

Purchase Blast$599.00

You can read the article’s full content online after purchase.

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. 

About The Author

Matthew Maryniak

|
President of Fenix Group International

Matthew has been a thought leader in the high-growth therapeutic areas of diabetes and cardiovascular medicine since 2006, making regular attendance at large and small CV/met scientific meetings and an architect of novel methods for assessing market opportunities. He has over a decade of experience in leading CV/met consulting engagements, is a published author in PM360 and Diabetes Technology & Therapeutics, and has been quoted in The Pink Sheet on anti-thrombotics.

If you receive our email blasts, you already have an account.

Purchase Blast$599.00

You can read the article’s full content online after purchase.

Lilly Expands Zepbound SDVs; Ph1 Lilly Amylin Results; D&D Ph2 Obesity Data; MBX Submits IND for Obesity Asset; June CHMP Agenda 

A series of cardiometabolic-related news items have been observed from Lilly, D&D Pharmatech, MBX Biosciences, and EMA. Below, FENIX provides highlights and insights for the respective news items.

About The Author

Matthew Maryniak

|
President of Fenix Group International

Matthew has been a thought leader in the high-growth therapeutic areas of diabetes and cardiovascular medicine since 2006, making regular attendance at large and small CV/met scientific meetings and an architect of novel methods for assessing market opportunities. He has over a decade of experience in leading CV/met consulting engagements, is a published author in PM360 and Diabetes Technology & Therapeutics, and has been quoted in The Pink Sheet on anti-thrombotics.

If you receive our email blasts, you already have an account.

Purchase Blast$599.00

You can read the article’s full content online after purchase.

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.

About The Author

Matthew Maryniak

|
President of Fenix Group International

Matthew has been a thought leader in the high-growth therapeutic areas of diabetes and cardiovascular medicine since 2006, making regular attendance at large and small CV/met scientific meetings and an architect of novel methods for assessing market opportunities. He has over a decade of experience in leading CV/met consulting engagements, is a published author in PM360 and Diabetes Technology & Therapeutics, and has been quoted in The Pink Sheet on anti-thrombotics.

If you receive our email blasts, you already have an account.

Purchase Blast$599.00

You can read the article’s full content online after purchase.

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.

About The Author

Matthew Maryniak

|
President of Fenix Group International

Matthew has been a thought leader in the high-growth therapeutic areas of diabetes and cardiovascular medicine since 2006, making regular attendance at large and small CV/met scientific meetings and an architect of novel methods for assessing market opportunities. He has over a decade of experience in leading CV/met consulting engagements, is a published author in PM360 and Diabetes Technology & Therapeutics, and has been quoted in The Pink Sheet on anti-thrombotics.

If you receive our email blasts, you already have an account.

Purchase Blast$599.00

You can read the article’s full content online after purchase.