Category Archives: Uncategorized

Novo, Dexcom, AZ, Sanofi, Biocon, and Teladoc Q1 ’22 Earnings Updates

A series of cardiometabolic-related news items have been observed: Novo (press release; slides), Dexcom (press release; slides), AZ (press release; slides), Sanofi (press release; slides), Biocon (press release), and Teladoc (press release; slides) hosted their respective Q1 ’22 earnings calls. Below, FENIX provides highlights and insights from the respective earnings 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.

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Novo Reports First QW Basal Insulin Icodec Ph3 Data

Novo announced topline results from its first QW basal insulin icodec Ph3 program (ONWARDS 2) comparing icodec to degludec in 526 patients with T2DM switching from QD insulin. Data demonstrated a statistically superior 0.93% reduction in A1C with icodec vs. 0.71% reduction with degludec. Below, FENIX provides thoughts into ONWARDS 2 icodec 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.

ATTD 2022 Key Press Releases (April 27); Abbott, Ypsomed, and CamDiab to develop AID System

On the first day of ATTD 2022, a series of diabetes-related press releases have been observed from Insulet, Welldoc, and Tandem. Separate from the conference, Abbott, Ypsomed, and CamDiab announced a partnership for the development of an AID system. 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.

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.

Novartis Q1 ’22 Earnings Update

Novartis hosted its Q1 ’22 earnings call (press release; slides) and provided brief updates to its CVRM business, including Entresto’s market performance and Leqvio’s commercialization. Additionally, management stated that the Sandoz strategic review remains in progress and reiterated expectations to provide an update by EOY. Below are highlights from the call.

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.

Daprodustat NDA Accepted by FDA; Sean Saint Looks to Do It Again; April 19-22 CHMP Agenda; J&J Q1 ’22 Earnings Update

Several cardiometabolic-related news items have recently been observed: GSK announced FDA accepted the daprodustat NDA for the treatment of patients with anemia due to CKD; Sean Saint has started a new company called Luna Diabetes (view website); the CHMP agenda for this month’s meeting (April 19-22) has been released; and J&J hosted their Q1’ 22 earnings call (press release; slides). Below, FENIX provides highlights and insights for the respective new 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/Ionis Ph2b Data @ ACC 2022; Novartis Restructures Pharma Business; Eversense E3 Launched in the US; Dexcom ONE to Launch in UK; New Sota and Kerendia Subanalyses @ ACC 2022; Fractyl Receives IDE for Second Pivotal Trial

A series of cardiometabolic-related news items have been observed from AZ/Ionis, Novartis, Ascensia/Senseonics, Dexcom, Lexicon, Bayer, DiaMedica, and Fractyl. Below, FENIX provides highlights and insights for the respective new 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.

Lannett Initiates Bs-glargine Pivotal Trial; Tirzepatide Meta-analysis Shows No Increased MACE Risk in T2DM; Provention Bio’s PRV-101 Vaccine Positive Final Results

A series of cardiometabolic-related news items have been observed: Lannett announced the initiation of its biosimilar insulin glargine pivotal trial; A CV safety meta-analysis for the tirzepatide Ph3 SURPASS program was published in Nature Medicine and showed no increased MACE risk in T2DM (view publication); and Provention Bio announced PRV-101 vaccine positive final results (press release). Below, FENIX provides highlights and insights for the respective new 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 to Implement 4:1 Stock Split; Libre Reimbursed in Japan for Basal-Only Patients; Ypsomed/CamDiab Ltd Collaboration; Movano Q4 ’21 and FY ‘21 Earnings Update

A series of cardiometabolic-related news items have been observed: Dexcom announced that the company’s Board of Directors has approved a four-for-one forward split of Dexcom’s common stock; Abbott announced the Japanese Ministry of Health, Labor and Welfare has approved reimbursement coverage for Libre in basal-only patients; Ypsomed announced a partnership with CamDiab Ltd for AID system development; and Movano hosted its Q4 ’21 earnings call (press release). Below, FENIX provides highlights and insights for the respective new 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.

Supersapiens Energy Band Review Published in Rouleur; Arecor Granted US Patent for Insulin Products; 9am.health and Ascensia Collaboration

A series of cardiometabolic-related news items have been observed: A review of the Supersapiens Energy Band Version Zero has been published in a well-known British cycling magazine (view review here); Arecor announced it has been granted patent US11278624 by the US Patent and Trademark Office protecting novel formulations of insulin products AT247 and AT278; and 9am.health announced Ascensia’s CONTOUR NEXT ONE blood glucose meter and CONTOUR NEXT test strips are now available to its prediabetes and T2DM patients. Below, FENIX provides highlights and insights for the respective new 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.

Medtronic Appoints New Diabetes EVP and Operating Unit President; Lexicon Loan Suggests No Priority Review for Sota; Diamyd Opens First EU Clinic for Ph3 DIAGNODE-3 Trial; Xeris Launches Gvoke Kit in US; DiaMedica Q4 and FY ’21 Earnings Update

A series of cardiometabolic-related news items have been observed: Medtronic announced leadership transitions for three of its operating units including diabetes, surgical robotics, and cardiac rhythm management; Lexicon announced it has entered into a loan facility agreement with Oxford Finance, providing up to $150M in borrowing capacity; Diamyd announced it has opened the first clinic in EU for initiation of its Ph3 DIAGNODE-3 trial in T1DM; Xeris announced it has launched its Gvoke Kit RTU glucagon (1mg/0.2 mL single-dose vial and syringe kit) in the US; and DiaMedica hosted its Q4 and FY ’21 earnings (press release). Below, FENIX provides highlights and insights for the respective new 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.