Category Archives: SGLT2i

Jardiance Positive HFpEF Topline Results (EMPEROR-Preserved)

BI/Lilly announced positive topline results from the Ph3 EMPEROR-Preserved trial, but it did not provide any information on the magnitude of effect. For context, EMPEROR-Preserved was evaluating 10mg empagliflozin in 5,988 adults with HFpEF, regardless of whether they have diabetes. Full results from EMPEROR-Preserved are scheduled to be presented as a Hot Line session at ESC 2021 on August 27. Below, FENIX provides a preliminary favors/disfavors analysis, including thoughts on how Lexicon’s sotagliflozin may still have residual value.

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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ADA 2021 Key Press Releases (June 29)

On the final day of ADA 2021, six cardiometabolic-related press releases were observed from Novo/Walmart, Lilly, Lexicon, Hanmi, Dario, and Adocia. Below, FENIX provides context and analysis for the announcements, including an RAI price-ranking following the Novo/Walmart partnership for ReliOn NovoLog.

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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ADA 2021 Key Press Releases (June 28)

On day four of ADA 2021, eight cardiometabolic-related news items were observed from Bigfoot, AZ, Mannkind, Medtronic, Senseonics, BI/Lilly, Sanofi, and REMD Biotherapeutics. Below, FENIX provides context and analysis for the announcements, including thoughts on how the ALT increases observed in REMD’s Ph2 volagidemab trial could spell disaster in Ph3.

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.

ADA 2021 Key Press Releases (June 25)

On the first day of ADA 2021, eleven cardiometabolic-related news items were observed from Medtronic, Lilly, AstraZeneca, CeQur, Abbott, Onduo, Glooko, Mannkind, ViaCyte, Glytec, and Akero. Below, FENIX provides context and analysis for the announcements.

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.

Jardiance HFrEF EC Approval; June 21-24 CHMP Agenda

Two cardiometabolic-related news items have been observed: BI/Lilly announced Jardiance received EC marketing authorization for the HFrEF indication; and the CHMP agenda for this month (June 21-24) has been released, and it includes one notable item, DAPA-CKD, as well as several other cardiometabolic-related entries. Below, FENIX provides highlights and insights from the respective 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.

ADA 2021 Abstract and Session Titles Available

ADA 2021 abstract and session titles are available through the ADA website. According to the ADA website, full abstract text will be available Tuesday, June 22 at 12:01am ET.

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.

EMPEROR-Reduced, DAPA-CKD, and Vericiguat Opinions?; May 17-20 CHMP Agenda

The CHMP agenda for this month (May 17-20) has been released, and it includes three notable items, EMPEROR-Reduced, DAPA-CKD, and vericiguat, as well as several other cardiometabolic-related entries. Below, FENIX provides highlights and insights from 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

You can read the article’s full content online after purchase.

DAPA-CKD Label Analysis; Farxiga Websites Updated

In late April 2021, FDA approved Farxiga for the treatment of CKD. The approval was based on results from the DAPA-CKD Ph3 trial which demonstrated a highly impressive 39% RRR in the primary composite endpoint (sustained ≥50% decline in eGFR, ESKD, renal death, or CV death; previous FENIX insight). Below, FENIX provides thoughts on the new Farxiga CKD indication, including read-through to finerenone, sotagliflozin, Jardiance and the rest of the SGLT2i class.

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.

Omnipod 5 Delayed; Insulet and Lexicon Q1 ’21 Earnings Updates

Lexicon (press release) and Insulet (press release) hosted their Q1 ’21 earnings calls and provided updates to their respective businesses. Importantly, Insulet disclosed there will be a delay to the Omnnipod 5 approval due to the COVID-mediated constraints within FDA. Below, FENIX provides highlights and insights from the calls.

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.

Farxiga DAPA-CKD Approved by FDA

Late today, AZ and FDA announced the approval of DAPA-CKD for Farxiga (AZ press release here | FDA press release here). The indication from the updated label reads as “…to reduce the risk of sustained eGFR decline, end stage kidney disease cardiovascular death and hospitalization for heart failure in adults with chronic kidney disease at risk of progression”.

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.