Category Archives: Topics

AstraZeneca Ph3 Baxdrostat Topline Results; FDA Approves Bayer’s Kerendia for HFpEF; Mattel Launches Barbie with T1DM 

Three cardiometabolic-related news items have been observed: AstraZeneca announced positive Ph3 topline results for baxdrostat in hypertension (view press release; view CT.gov record), Bayer announced FDA approval of Kerendia’s (finerenone) HEpEF indication (view press release), and Mattel announced the launch of a Barbie with diabetes (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.

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FDA Publishes Slew of CRLs in Effort to Increase Transparency

FDA announced it has published more than 200 CRLs to increase transparency. The CRLs were issued to applications submitted between 2020 and 2024, and all are for drugs that have since gained approval from the agency, a Department of Health and Human Services spokesperson told Fierce Biotech (view article). Below, FENIX provides an overview of select CRLs and brief insight into the FDA openness policy.

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.

Protagonist to Advance Obesity Asset; Syntis Raises $33M Series A

Two cardiometabolic-related news items have been observed: Protagonist Therapeutics announced its new triple agonist obesity asset (view press release); and Syntis Bio raised Series A funding (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.

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.

Abvance Receives Financing and Expands Leadership 

Abvance Therapeutics announced the closing of its strategic seed financing, which the company plans to use to support its early development programs and expand its executive/board teams. Jaivir Pall, Investment Director for diabetes at Zubi Capital, and Brent Ahrens, General Partner at Canaan Partners have been appointed to Abvance’s Board of Directors as new members. Notably, no specific figures related to the funding were disclosed. Below, FENIX provides a summary of the additional leadership changes and brief insights.

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.

Thoughts on MariTide Ph2 Data; Amgen ADA 2025 Investor Event 

Following the Ph2 MariTide (QM/Q2M SC GLP-1RA/GIP antagonist) data readout (previous FENIX insight), Amgen hosted its ADA 2025 investor event (view slides; view webcast) and provided additional context on the results as well as the Ph3 MARITIME program. Management highlighted that the Ph3 MARITIME program will employ a three-step dose escalation scheme, with lower initial starting doses, as an effort to mitigate the tolerability concerns observed during Ph2 development. Below, FENIX provides updates and insights from the call, including thoughts on the benefits/risks of conducting a H2H trial vs. tirzepatide.

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.