Category Archives: Other

Arrowhead CY Q3 ’24 (FY Q4 ’24) Earnings; Embecta Discontinues Patch Pump; New Medicare and Medicaid Obesity Proposal; EOFlow Wins Legal Battle in the EU

Arrowhead CY Q3 ’24 (FY Q4 ’24) Earnings; Embecta Discontinues Patch Pump; New Medicare and Medicaid Obesity Proposal; EOFlow Wins Legal Battle in the EU

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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Amgen MariTide Ph2 Topline Results; Alnylam sNDA Accepted for Vutrisiran with PRV; Novartis Investor Event

Three cardiometabolic-related news items have been observed: Amgen announced topline 52-week data from its Ph2 MariTide obesity study (view press release); Alnylam announced FDA accepted the vutrisiran sNDA for the treatment of ATTR-CM with a PDUFA date on March 25, 2025 (view press release); and Novartis recently hosted a “Meet the Management” investor day (view press release; CEO presentation; breakout slides). Below, FENIX provides highlights and insights for the respective news items, including thoughts on Amgen’s placement in the obesity treatment paradigm. 

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.

Lexicon Strategic Update; Boston MASH Investor Event; Ypsomed to Manufacture Cargisema Pens; Pep2Tango Obesity Startup; Generic Byetta FDA Approval

A series of cardiometabolic-related news items have been observed from Lexicon Pharmaceuticals, Boston Pharmaceuticals, Ypsomed, Versant Ventures, and Amneal 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.

Diamyd Ph3 Recruitment Update

Diamyd Medical announced it has enrolled 180 patients in the Ph3 DIAGNODE-3 trial (view CT.gov record), exceeding the recruitment target set for the planned early readout in March 2026. For context, DIAGNODE-3 is evaluating the Diamyd diabetes vaccine in 330 recently diagnosed T1DM patients 12-28 years of age who carry the HLA DR3-DQ2 haplotype (previous FENIX insight). Recall, in September 2024, Diamyd announced it will pursue accelerated approval in the US (previous FENIX insight). Below, FENIX provides brief insight on the Diamyd approval timeline.

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 and Laekna Obesity Partnership; Viking Ph2b MASH Data; Medtronic InPen App FDA Clearance; Omnipod 5 and FreeStyle Libre 2 Plus Integration; Flagship and Ampersand Obesity Partnership; NewAmsterdam Ph3 TANDEM CV Data

A series of cardiometabolic-related news items have been observed from Lilly, Viking, Medtronic, Insulet, Pfizer, and NewAmsterdam 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.

Dexcom and Oura Partnership; Novo ESSENCE Data at AASLD; Medtronic CY Q3 ’24 (FY Q2 ’25) Earnings; Silence, Esperion, NewAmsterdam, and Arrowhead Data at AHA 2024; Aligos Ph2 MASH Data; Biomea COVALENT-111 Analysis

A series of cardiometabolic-related news items have been observed from Dexcom, Novo Nordisk, Medtronic, Silence Therapeutics, Aligos Therapeutics. Biomea Fusion, Esperion, NewAmsterdam Pharma, and Arrowhead. 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 Releases HFpEF and Lp(a) Data; Inventiva and Sagimet MASH Data at AASLD; New Abbott Manufacturing Facility; NeuroBo Name Change

A series of cardiometabolic-related news items have been observed from Lilly, Inventiva, Sagimet Biosciences, Abbott, and NeuroBo 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.

Boston Pharmaceuticals Ph2a MASH Topline Results

Boston Pharmaceuticals announced positive topline results from its Ph2a study (view CT.gov record) evaluating efimosfermin alfa (formerly BOS-580; SC QM FGF21 analog) in participants with F2/F3 fibrosis due to MASH. Of note, results will be presented at AASLD 2024 (Nov 15-19; San Diego, CA) and the company will host an investor event to discuss the data on November 21, 2024 (view webcast). Below, FENIX provides highlights and insights for the topline results.

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.

Tirzepatide Full Surmount-1 Three-Year Results; Novo to Discontinue Human Insulin Pens; Hims & Hers Launches GLP-1RA Shortage Tracker; Skye Enrollment Update

A series of cardiometabolic-related news items have been observed from Lilly, Novo Nordisk, Hims & Hers, 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.

New Zepbound DTC Observed; New Novo Insulin Trial; Amgen Damage Control; Lexicon, Fractyl, and Terns Q3 ‘24 Earnings; Metsera Series B Financing; G&L Oral GLP-1RA Data

A series of cardiometabolic-related news items have been observed from Lilly, Novo Nordisk, Amgen, Lexicon Pharmaceuticals, Fractyl Health, Terns Pharmaceuticals, Metsera, and Gan & Lee. 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.