Category Archives: Topics

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.

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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.

OFA Responds to Novo’s Petition on Semaglutide Compounding; PreEvnt Announces New Non-Invasive Glucose Monitor; Novo Holdings and Lilly Invest in Orbis Series A Financing

Three cardiometabolic-related news items have been observed: The Outsourcing Facilities Association (OFA) responded to Novo’s petition to add semaglutide to FDA’s Demonstrable Difficulties for Compounding Lists (DDC Lists; view document); PreEvnt announced a new non-invasive glucose monitor that uses the patient’s breath (view press release); and Novo Holdings and Lilly participated in Orbis Medicines’s €90M Series A financing for oral macrocycle drugs (view Orbis press release; view Novo Holdings 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.

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.

Holiday Hangover: FDA Approves Zepbound for OSA; NICE Finalizes Tirzepatide Guidelines; Abbott and Dexcom Reach Agreement; Arrowhead Ph1/2a ARO-INHBE Trial in Obesity; AZ Initiates Ph2 MASH Trial; Zealand Petrelintide Commentary; Generic Liraglutide Approvals; Lexicon Receives CRL for Zynquista

During the holiday break, a series of cardiometabolic-related news items were observed from Lilly, NICE, Dexcom/Abbott, Arrowhead Pharmaceuticals, AstraZeneca, Zealand Pharma, Biocon/Hakima, and Lexicon 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.

Dexcom Participates in Oura Funding; Galectin Misses MASH Endpoint in Ph2b/3 Trial

Two cardiometabolic-related news items have been observed: Oura announced Dexcom participated in its Series D funding round (view press release); and Galectin Therapeutics missed the primary endpoint in its Ph2b/3 NAVIGATE MASH trial (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.

Cagrisema Misses Weight Loss Target

Novo Nordisk announced topline results from its first Ph3 pivotal cagrisema trial (REDEFINE 1; view CT.gov record) demonstrating -22.7% weight loss at Week 68, although Novo projected it would achieve 25%. For context, the trial evaluated cagrisema (a fixed-dose combination of cagrilintide 2.4mg and semaglutide 2.4mg) vs. cagrilintide 2.4mg, semaglutide 2.4mg, and placebo. Novo’s stock decreased by ~20% following the announcement. Below FENIX provides highlights and insights from the REDEFINE 1 trial, including readthrough to other obesity assets in development.

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 Releases Status on GLP-1RA Supply; AZ Initiates Baxdrostat/Dapa Trial in CKD and CV; TIXiMED Announces $2.65M Investment

Three cardiometabolic-related news items have been observed: FDA clarified the tirzepatide shortage resolution and impact on compounding pharmacies (view report); AstraZeneca initiated a Ph3 baxdrostat/dapagliflozin renal outcomes and CV mortality trial (view CT.gov record); and TIXiMED announced a $2.65M Helmsley Charitable Trust investment (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.

Merck Buys Oral GLP-1RA; MetaVia Topline Ph2a MASH Data; Structure Reveals New DACRA Obesity Asset; Novo/Photys Enter Research Partnership; G&L Initiates H2H Tirzepatide Trial; EMA to Discuss Semaglutide Rare Eye Disease Association; Novo/Catalent Deal Complete

A series of cardiometabolic-related news items have been observed from Merck/Hansoh Pharma, Metavia, Structure Therapeutics, Novo Nordisk/Photys Therapeutics, Gan & Lee, Novo/EMA, and Novo/Catalent. 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.

Dexcom Integrates AI Into Stelo; Biomea Topline Icovamenib T2DM Data

Two cardiometabolic-related news items have been observed: Dexcom announced it is integrating Generative AI (GenAI) into its Stelo CGM platform to analyze individual health data patterns (view press release); and Biomea Fusion announced positive topline results from the ongoing COVALENT-111 study in T2DM (view CT.gov record). 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.