Category Archives: SGLT2i

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.

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December CHMP Agenda; Senseonics Eversense 365 Launch Updates; BioAge Discontinues Ph2 Obesity Trial

Three cardiometabolic-related news items have been observed: the CHMP agenda for this month’s meeting (Dec 9-12) has been released (view here); Senseonics announced commercial updates to its Eversense 365 launch (view press release); and BioAge announced the discontinuation of its Ph2 obesity 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.

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.

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.

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.

AZ, Altimmune, and Scholar Rock Q3 ’24 Earnings; New Ph2 Lilly Trial Observed

A series of cardiometabolic-related news items have been observed from AstraZeneca, Altimmune, Lilly, and Scholar Rock. 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.

AZ Initiates Dapa Combination Trial in HF; Ionis and Teva Q3 ’24 Earnings

Three cardiometabolic-related news items have been observed: AstraZeneca initiated a Ph3 baxdrostat + dapagliflozin combination trial in HF (Prevent-HF; view CT.gov record); Ionis (press release; slides) and Teva Pharmaceuticals (press release) hosted their respective Q3 ’24 earnings calls. 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.

Zynquista Negative Adcom Vote; Novo STEP-9 Results Published; Wegovy Removed from FDA Shortage List; Amgen, Madrigal, Biomea, Teladoc, and Amarin Q3 ’24 Earnings; BI/Gubra Discontinue NPY2 for Obesity; Inventiva Positive DMC Recommendation for Ph3 MASH Trial

A series of cardiometabolic-related news items have been observed from Lexicon, Novo Nordisk, Amgen, Madrigal, Biomea Fusion, BI/Gubra, Inventiva, Teladoc, and Amarin. 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.

Lexicon Faces Uphill Battle in Sota T1DM Adcom; Pfizer and Novartis Q3 ’24 Earnings; Sanofi Invests in Another Obesity Asset; MariTide T2DM Trial; Sagimet to Advance Denifanstat MASH Development

A series of cardiometabolic-related news items have been observed from FDA/Lexicon, Pfizer, Novartis, Sanofi, Amgen, and Sagimet Biosciences. 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.