Category Archives: Topics

AbbVie Q1 ‘25 Earnings; Madrigal Hires Ex-Novartis CVRM Development Lead

Two cardiometabolic-related news items have been observed: AbbVie hosted its Q1 ’25 earnings call (press release); and Madrigal Pharmaceuticals appointed former Novartis drug development lead, David Soergel, as its new CMO (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.

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Purchase Blast$599.00

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Medtronic Seeks Interoperability; Roche, Viking, Sanofi, and Merck Q1 ‘25 Earnings; Zealand Enrolls First Patient in Ph2 T2DM Study; Esperion R&D Day 2025

A series of cardiometabolic-related news items has been observed by Medtronic, Roche, Viking Therapeutics, Zealand Pharma, Sanofi, Merck, and Esperion. 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’s Two New Ph3 Studies in Obesity; Ascletis Ph1 Obesity Study Topline Results; Zealand Hires Ex-Lilly Exec; Lilly Sues Compounders…Again 

A series of cardiometabolic-related news items has been observed from Lilly, Ascletis Pharma, and Zealand 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.

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 Files HD Oral Sema; Roche Expands US Manufacturing; MetaVia Additional Ph1 Obesity Results; Ypsomed Sells Diabetes Care Business; Biolinq $100M Series C; April CHMP Agenda 

A series of cardiometabolic-related news items has been observed from Novo Nordisk, Roche, MetaVia, Ypsomed, Biolinq, 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.

Medtronic Receives FDA Approval for Simplera + MiniMed 780G

Medtronic announced FDA approval of the supplemental PMA for Medtronic’s Simplera Sync CGM sensor for use with the MiniMed 780G system. Recall, the standalone Simplera CGM was approved by FDA in August 2024 (previous FENIX insight). According to the press release, a limited US launch of the Simplera Sync sensor will begin in Fall 2025. Below, FENIX provides brief insight into the approval.

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 Ph3 Orforglipron T2DM Topline Results

Lilly announced topline results from its first Ph3 pivotal orforglipron (oral QD GLP-1RA) trial (ACHIEVE-1; view CT.gov record) demonstrating -1.5% reduction in A1C and -7.9% weight loss at the highest dose (36mg) at Week 40. For context, ACHIEVE-1 (n=559) evaluated the safety and efficacy of orforglipron vs placebo in adults with T2DM and inadequate glycemic control with diet and exercise alone. Lilly’s stock increased ~15% following the announcement. Below, FENIX provides highlights and insights from the ACHIEVE-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.

Abbott Q1 ’25 Earnings Update 

Abbott hosted its Q1’25 earnings call (press release; infographic). Of note, there was minimal discussion of Abbott’s CGM business in prepared remarks and no questions from analysts during Q&A. Abbott’s CEO Rob Ford specifically stated, “I found it interesting we did not get a single Libre question, so you guys are very concerned on tariffs and macro…” Below, FENIX provides brief highlights and insights from the call.

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.

Zealand Accelerates Hiring & Initiates New Ph2 Petrelintide Study; Merck Licenses Oral Drug Delivery Platform; MetaVia Ph1 Obesity Results; Skye Preclinical Obesity Results 

A series of cardiometabolic-related news items has been observed from Zealand Pharmaceuticals, Merck, MetaVia, and Skye Bioscience. 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.

Pfizer Discontinues Danuglipron in Obesity; Verve Shares Initial Ph1b HeFH/CAD Data; Novo Warns Against Counterfeit Ozempic; Syntis Announces Preliminary Data in Obesity 

A series of cardiometabolic-related news items has been observed from Pfizer, Verve Therapeutics, Novo Nordisk, and Syntis Bio. 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 Receives FDA Clearance for G7 15 Day CGM

Dexcom announced it received FDA clearance for its G7 15 Day CGM for people over the age of 18 with diabetes. The G7 15 Day CGM is expected to launch in H2 2025, and the company noted it is working to ensure its new CGM is compatible with its current insulin pump partners at launch. Recall, in October 2024, Dexcom disclosed that it submitted the 15 Day for FDA approval (previous FENIX insight). Below, FENIX provides highlights and insights on the approval.

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.