Category Archives: Topics

AZ Q3 ’21 Earnings Update; J&J to Split Consumer and Pharma/Med Device Business

Two cardiometabolic-related news items have been observed: AstraZeneca hosted its Q3 ’21 earnings call (press release; slides) and J&J announced plans to split the company’s pharma/med device and consumer businesses into separate companies. 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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UPDATED: Finerenone US Launch Analysis

Ahead of Bayer’s Kerendia (finerenone) investor webinar on Monday, November 15 @ 9 AM ET (view link to webcast), FENIX has conducted a follow-on launch analysis. In case you missed it, FENIX performed an early Kerendia launch and HCP website analysis in October 2021 (previous FENIX insight). Below, FENIX provides an analysis of the developing Kerendia Rx data, including a time-aligned launch comparison with other key brands to see if Kerendia’s launch is more like Entresto or Brilinta.

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.

BI/Lilly’s Jardiance Receives FDA Priority Review; Novo’s Wegovy Receives Positive CHMP Opinion; Merck/Bayer Initiate New Ph3 Verquvo Study; Dario Enters Three New Commercial Agreements; Gmax Administers First in Human Dose of GMA106 in Ph1 Obesity Study; Metacrine and Zealand Q3 ’21 Earnings Updates

A series of cardiometabolic-related news items have been observed from BI/Lilly, Novo Nordisk, Zealand, Merck/Bayer, Dario, Gmax Biopharma, and Metacrine. Below, FENIX provides highlights and insights for the respective news items, including an updated projection of the EMPEROR-Preserved PDUFA date.

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.

MannKind and Xeris Biopharma Q3 ’21 Earnings Updates

MannKind (press release; slides) and Xeris Biopharma (press release) hosted their respective Q3 ’21 earnings calls. Below, FENIX provides highlights and insights from the events.

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.

Bayer and Senseonics Q3 ’21 Earnings Updates; Abbott and ADA Launch Community Initiative; Provention Bio Launches #Type1TestedPledge Campaign; Beyond Type 1 Receives $750,000 Grant

A series of cardiometabolic-related news items have been observed: Bayer (press release; slides) and Senseonics (press release) hosted their respective Q3 ’21 earnings calls; Abbott and the American Diabetes Association (ADA) announced the launch of their first joint community initiative in Columbus, Ohio; Provention Bio announced the launch of its #Type1TestedPledge Campaign for Diabetes Awareness Month; and Beyond Type 1 announced it has received a $750,000 Grant from the Helmsley Charitable Trust. Below, FENIX 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.

November 8-11 CHMP Agenda; Kerendia+SGLT2i Reduce Risk of Composite CV Outcome; Viatris Q3 ’21 Earnings Update

A series of cardiometabolic-related news items have been observed: the CHMP agenda for this month’s meeting (November 8-11) has been released; Bayer announced positive results from an additional sub-analysis from the Ph3 FIDELITY trial demonstrating Kerendia (finerenone) in conjunction with SGLT2i reduced the risk of the composite CV outcome; and Viatris hosted its Q3 ’21 earnings call (press release; slides). Below, FENIX 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.

GSK’s Daprodustat Ph3 Data Positive But Not Entirely Clean; BI/Lilly’s Jardiance Demonstrates Consistent Cardio-Renal Benefits in HF; Novo Announces Positive Ph3b STEP 5 Trial Results; CytoDyn Reports Positive Preliminary Data from Ph2 Leronlimab Trial; Roche and Sanofi Mallya Collaboration; Intuity Medical’s Automatic BGM Available in US; Zealand and DEKA Collaboration for Continuous Infusion Pump

A series of cardiometabolic-related news items have been observed from GSK, BI/Lilly, Novo Nordisk, CytoDyn, Roche, Intuity Medical, and Zealand. 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.

Viatris’s Semglee Gains Preferred Status on Prime Therapeutics’s National Formularies; Zealand’s First Patient Dosed with ZP8396 in Ph1 Trial for Obesity; Insulet, Lannett, Ionis, Provention Bio, BD, and Regeneron Q3 ‘21 Earnings Updates

A series of cardiometabolic-related news items have been observed from Prime Therapeutics, Zealand, Lannett, Ionis, Provention Bio, Becton Dickinson, Regeneron, and Dario. 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, Tandem, Amarin, Intercept, and Amgen Q3 ’21 Earnings Updates

A series of cardiometabolic-related news items have been observed: Lexicon (press release), Tandem (press release), Amarin (press release; slides), Intercept, (press release; slides), and Amgen (press release; slides), hosted their respective Q3 ’21 earnings calls. Importantly, Lexicon discussed its US sotagliflozin commercial strategy suggesting it is moving forward on its own. 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.

Novo Nordisk Q3 ’21 Earnings Update

Novo Nordisk hosted its Q3 ’21 earnings call (press release; slides) and provided updates across its commercial and pipeline activities, including the ongoing Wegovy and Rybelsus launches, and updates about various pipeline projects. Below, FENIX provides highlights and insights 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.