Tag Archives: NOVO

EASD 2025 Key Press Releases (September 19) 

On the final day of EASD 2025, four key news items were observed from Novo Nordisk, Skye Bioscience, Ionis/Sobi, and Innovent. 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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Novo Advances Amycretin to Ph3; Medtronic Diabetes Reclaims MiniMed Name; Vertex Layoffs After Failed T1DM Program 

Three cardiometabolic-related news items have been observed: Novo Nordisk advances amycretin into Ph3 development (view press release); Medtronic named its diabetes spinoff company “MiniMed” (view press release); and Vertex lays off employees due to its failed T1DM program (view article). 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.

Zepbound SDV Label Update; Semaglutide Reduces Alcohol Cravings; Alnylam Q4 ’24 Earnings; NYT Article Features HCPs Using GLP-1RAs; Aardvark IPO

A series of cardiometabolic-related news items have been observed from Lilly, Novo Nordisk, Alnylam, The New York Times, and Aardvark Therapeutics. 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.

Sema on Medicare Negotiation List; STEP UP Topline Results; Long-Term Cagrisema Trial; EMA Reviewing Sema for NAION Risk

A series of cardiometabolic-related news items has been observed by CMS, Novo Nordisk, and EMA. Below, FENIX provides highlights and insights for the respective news items, including thoughts on Novo’s high-dose semaglutide readout.

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.

JPM 2025 Day 3: PODD, MDGL, BMEA, IONS, SANA; Novo Wins PRV; Mounajro DTC; Lexaria Oral Liraglutide; Wisp Sublingual Sema

On the third day of JPM 2025, FENIX has provided coverage of presentations by major CVRM companies, including Insulet, Madrigal, Biomea Fusion, Ionis, and Sana Biotechnology. Separately, a series of CVRM-related news items has been observed:

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.

FDA Draft AOM Guidance; Novo/Valo Expand Partnership; Viking Initiates Oral VK2735 Ph2 Trial; Glooko/Hedia Integration; Sana Islet Cell Therapy T1DM Success; Found Expands to Dissolvable Oral Semaglutide

A series of cardiometabolic-related news items have been observed from FDA, Novo Nordisk/Valo Health, Viking Therapeutics, Glooko/Hedia, Sana Biotechnology, and Found. Below, FENIX provides highlights and insights into 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/Variant Partnership; Metsera Ph2a GLP-RA Data; Tandem/UVA Partnership; Biomea Icovamenib/Semaglutide Preclinical Data; Diamyd Publication; CeQur Financing Round

A series of cardiometabolic-related news items have been observed from Novo Nordisk/Variant Bio, Metsera, Tandem, Biomea Fusion, Diamyd Medical, and CeQur. FENIX will provide an overview of the updated FDA guidance (view here) on obesity and overweight medications in tomorrow’s blast. 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.

Lilly Requests to Join Compounding Lawsuit; 2026 Medicare/Medicaid Obesity Proposal; Novo Petitions FDA For Compounding

Three cardiometabolic-related news items have been observed: Lilly requested to join tirzepatide compounding lawsuit (view article); CMS and HHS released the 2026 policy and technical changes to the Medicare/Medicaid programs and included proposed guidance for anti-obesity medications (view document); and Novo Nordisk has continued to petition FDA to stop compounding of Victoza (view article). 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.

November CHMP Agenda

The CHMP agenda (view here) for this month’s meeting (Nov 11-14) has been released and includes several cardiometabolic-related agenda items. Below, FENIX provides highlights and insights for the agenda.

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 London, Tandem, Zealand, NewAmsterdam, Esperion, Viatris, and Dario Q3 ’24 Earnings; Altimmune Ph3 Obesity Program

A series of cardiometabolic-related news items have been observed from Novo Nordisk, Tandem Diabetes Care, Zealand Pharma, Altimmune, NewAmsterdam Pharma, Esperion, Viatris, and DarioHealth. 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.