Category Archives: GLP-1RA

July CHMP Agenda; MiniMed 780G CE Mark for Expanded Indication; Dexcom Receiver Recall  

Three cardiometabolic-related news items have been observed: The CHMP agenda for this month’s meeting (July 21-24) has been released (view here); Medtronic announced its MiniMed 780G pump received CE Mark for ages 2+ years of age, T2DM, and during pregnancy (view press release); and FDA announced Dexcom’s CGM receivers have been recalled for faulty alert sounds (view press release). Below, FENIX provides highlights and insights for the respective news items, including thoughts on Novo’s EU semaglutide MASH regulatory strategy.

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.

Obesity Spotlight: How will Merck Replace Keytruda Revenue?

In the seventh installment of FENIX’s Obesity Spotlight Series, FENIX has conducted a deep dive analysis of Merck’s current position in the obesity market. The analysis includes insights into Merck’s strategy to replace Keytruda revenue and how Merck may focus its obesity efforts on a FDC approach.

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.

Abbott and Novartis Q2 ‘25 Earnings; Biomed Ph2 Quadruple Agonist Obesity Data; BMS/Pfizer Offers Eliquis in DTP Platform 

A series of cardiometabolic events has been observed from Abbott, Novartis, Biomed Industries, and Bristol Myers Squibb/Pfizer. 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.

Sernova and Eledon Partner for T1DM; Lilly’s Zepbound KwikPen Approved in Canada; Altimmune Enrolls First Patients in Ph2 ALD Study; MetaVia Doses First Patient in Ph1 Obesity Study

A series of cardiometabolic-related news items have been observed from Sernova Biotherapeutics/Eledon Pharmaceuticals, Lilly, Altimmune, and MetaVia. 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 Submits High-Dose Sema to EMA; Esperion Generic Bempedoic Acid Settlement; Allurion Files Gastric Balloon to FDA; Arrowhead Initiates Ph3 Zodasiran Study 

A series of cardiometabolic-related news items has been observed from Novo Nordisk, Esperion, Allurion Technologies, and Arrowhead Pharmaceuticals. 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.

Innovent’s Mazdutide Approved in China; Roche Leadership Changes; Apple Tree Partners Legal Battle  

Three cardiometabolic-related news items have been observed: Innovent announced mazdutide approval in China (view press release); Roche is making changes to its executive leadership (view press release); and Apple Tree Partners’s ongoing litigation will potentially impact its portfolio companies (view article). 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.

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.

Viking Initiates its Ph3 Study for VK2735; Rivus Shares Topline Ph2 Data in MASH; Lilly Initiates New Ph2 Study of Naperiglipron in Obesity and Ph3 Study of Retatrutide in CLBP; Letter to FDA Pushing for T1DM Treatments; MindRank Announces Ph2b Data for its Oral GLP-1RA 

A series of cardiometabolic-related events has been observed from Viking Therapeutics, Rivus Pharmaceuticals, Lilly, FDA, and MindRank. 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.

ADA 2025 Key Press Releases (June 23)  

On the final day of the ADA 2025 conference, six cardiometabolic-related news items have been observed from Amgen, Novo Nordisk, Lilly, Lexicon Pharmaceuticals, and Terns Pharmaceuticals. Of note, Amgen is hosting an investor call discussing the MariTide Ph2 results, and FENIX will provide updated thoughts after the team heads back from Chicago, including a benefit/risk analysis of conducting a H2H trial vs. tirzepatide. 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 ADA 2025 Investor Event; Efsitora Alfa QW Insulin Ph3 Data

Lilly hosted its ADA 2025 investor call and provided updates across its obesity portfolio, including orforglipron, retatrutide, and other early pipeline assets (view webcast). Lilly separately announced the presentation of Ph3 QW insulin efsitora alfa data (view press release). Of note, Ken Custer, Lilly’s new BU head for Cardiometabolic Health (previous FENIX insight), presented to investors for the first time. Below, FENIX provides an overview of the Lilly ADA investor event.

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.