Category Archives: Other

Galmed MASH Open-Label Publication; Entera/OPKO GLP-1/GCG Pre-Clinical Update

Two cardiometabolic-related news items have been observed: Galmed published one-year open-label results from its Ph3 MASH study (view press release; view publication); and Entera Bio and OPKO Health provided updates on its preclinical oxyntomodulin asset in obesity (view press release). 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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Metsera Reports Positive Ph1 Obesity Topline Results; Novo CEO Testifies at Senate HELP Committee Hearing

Two cardiometabolic-related news items have been observed: Metsera announced positive topline results from its Ph1 clinical trial of MET-097, its ultra-long-acting injectable GLP-1RA (view press release); and Novo Nordisk’s CEO, Lars Fruergaard Jørgensen, testified at the Senate Committee on Health, Education, Labor, and Pensions (HELP) hearing titled, “Why Is Novo Nordisk Charging Americans with Diabetes and Obesity Outrageously High Prices for Ozempic and Wegovy?” (view broadcast here). Below, FENIX provides insight into Metsera’s first obesity data readout as well as initial thoughts on the Senate HELP committee hearing.

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.

Skye Defends Nimacimab After Disappointing Novo Obesity Data; Sanofi Invests in Obesity Asset; Arrowhead Files to Initiate ARO-INHBE Obesity Study

Three cardiometabolic-related news items have been observed: Skye Bioscience released a statement highlighting differences between nimacimab and Novo Nordisk’s monlunabant following Ph2a monlunabant topline data (view press release); Ventyx Biosciences announced a $27M investment from Sanofi for first negotiation rights of its VTX3232 obesity asset (view press release); and Arrowhead announced it filed for regulatory clearance to initiate a Ph1/2a trial of ARO-INHBE in obesity (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.

Novo CB1 Ph2a Obesity Topline Results; Two Ph3 Tirzepatide Combo Psoriatic Studies Observed; Aligos Ph2a MASH Topline Results; AZ Initiates Ph2 LA Amylin Obesity Study; FTC Sues PBMs; Synjardy Receives Pediatric CHMP Positive Opinion

A series of cardiometabolic-related news items have been observed from Novo Nordisk, Lilly, Aligos Therapeutics, AstraZeneca, FTC, and CHMP. 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.

Wegovy HFpEF CHMP Opinion; Lilly Amylin+Tirzepatide Obesity Study; Another Compounded Semaglutide and Tirzepatide; Tandem t:slim X2 Compatible with Lyumjev

A series of cardiometabolic-related news items have been observed from Novo Nordisk, Lilly, Ahara Corporation, and Tandem Diabetes Care. 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 Enters Partnership with NanoVation for Cardiometabolic and Rare Diseases; Lilly and Axcelead Enter Development Partnership

Two cardiometabolic-related news items have been observed: NanoVation Therapeutics announced it entered into a multi-year partnership with Novo Nordisk for cardiometabolic and rare disease development (view press release); and Axcelead Drug Discovery Partners announced it entered into a development partnership with Lilly for multiple drug discovery programs (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.

Eversense 365 Day CGM Receives FDA Clearance

Senseonics Holdings and Ascensia Diabetes Care announced FDA cleared the implantable Eversense 365 CGM as an iCGM system for people with T1DM and T2DM aged 18 years and older. Senseonics stated it is continuing to progress partnership discussions with various pump manufacturers looking to leverage Eversense 365 with AID systems. Ascensia plans to initiate the US launch of Eversense 365 in early Q4 2024. Below, FENIX provides brief insights into the 510(k) clearance.

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.

September CHMP Agenda; Novo Collaboration with Korro; Jeff Wade Leaves Lexicon

Three cardiometabolic-related news items have been observed: the CHMP agenda for this month’s meeting (Sept 16-19) has been released (view here); Korro and Novo Nordisk initiated a collaboration for cardiometabolic disease drug discovery (view press release); and Lexicon Pharmaceuticals announced the departure of Jeff Wade, its president and COO (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.

Roche in Damage Control Mode After EASD Obesity Data Readout

Roche hosted a post-EASD investor event (view slides) where management reviewed its obesity data presentations and provided additional insight into the company’s obesity development strategy and pipeline. Of note, Roche spent a significant portion of the call discussing the emerging AE profile for its obesity assets and the company’s future plans to remain a player in the obesity market. Below, FENIX provides highlights and insights into the Roche event, including thoughts on whether Roche overpaid for Carmot.

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.

EASD 2024 Key Press Releases (Sep 12)

On the fourth day of EASD 2024, three key new items were observed from Noom, Lilly, and Sernova. The following topics are covered below (hyperlinks to external 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.