Category Archives: SGLT2i

Jardiance EMPULSE Trial Published; Senseonics Q4 ’21 Earnings Update; Novo Initiates Icosema COMBINE 2 Ph3 Trial; Merck’s Oral PCSK9i Enters Ph2; BI Partners with Lifebit; Intercept and Amarin Q4 ’21 Earnings Updates

A series of cardiometabolic-related news items have been observed from BI/Lilly, Senseonics, Novo, Merck, BI/Lifebit, Intercept, and Amarin. 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.

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Lexicon Faces Another Sota Setback; Biocon to Acquire Viatris Biosimilars Business; Viatris Confirms Generic Ozempic Filing

A series of cardiometabolic-related news items have been observed: Lexicon announced it has withdrawn the sotagliflozin HF NDA; Lexicon hosted its Q4 and FY ’21 earnings call (press release); Biocon/Viatris announced Biocon will acquire the Viatris Biosimilars business; Viatris hosted an investor day and disclosed it has filed a generic Ozempic (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.

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Purchase Blast$599.00

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

EMPEROR-Preserved Approved by FDA; Wegovy Supply Restored for Existing US Patients; Provention Bio Q4 and FY ’21 Earnings Update; Omada Closes $192M Series E

A series of cardiometabolic-related news items have been observed: FDA approved BI/Lilly’s HFpEF indication (view FDA press release; view BI/Lilly press release); Novo Nordisk’s Wegovy supply for existing US patients has been restored (view Novo Nordisk website); Provention Bio hosted its Q4 and FY ’21 earnings call (view press release); and Omada Health raised $192M in a Series E round (view 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.

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Purchase Blast$599.00

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

Bayer Initiates Kerendia and Jardiance Combo Trial Following Kerendia EU Approval

Bayer announced the initiation of CONFIDENCE, a Ph2 study evaluating the combination therapy of Kerendia (finerenone) and Jardiance (empagliflozin) in patients with CKD and T2DM (view CT.gov record). The trial initiation follows the recent EU approval of finerenone for CKD associated with T2DM in adults (view press release). Recall, finerenone was approved in the US in July 2021 (previous FENIX insight) and is currently under review in China and multiple other countries worldwide. Below, FENIX provides insights into the new CONFIDENCE trial, including thoughts on Bayer’s strategy to do the Ph2 trial with empa instead of dapa.

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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Provention Bio Refiles Teplizumab BLA; Medtronic and Tandem Q4 ’21 and FY ’21 Earnings Updates; Lilly Invests $700M in New Lilly Institute for Genetic Medicine; RosVivo Therapeutics and Lilly Sign MTA for RSVI-301; February 21-24 CHMP Agenda

A series of cardiometabolic-related news items have recently been observed from Provention Bio, Medtronic, Tandem, Lilly, RosVivo Therapeutics, and the CHMP. 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.

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Purchase Blast$599.00

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Novo Sues Teva Over Generic Saxenda; Cytokinetics Announces Disappointing METEORIC-HF Results; Zealand’s Pediatric Ph3 Dasiglucagon in CHI Trial Completes Enrollment

A series of cardiometabolic-related news items have been observed: It has been reported that Novo Nordisk has filed a suit against Teva regarding Teva’s recently filed generic version of Saxenda (view article); Cytokinetics announced topline results from the Ph3 METEORIC-HF trial which failed to demonstrate a benefit in exercise performance; and Zealand announced its Ph3 pediatric trial evaluating dasiglucagon in CHI has completed enrollment (view CT.gov record). 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.

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Purchase Blast$599.00

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

AZ Q4 ’21 and FY ’21 Earnings Update

AstraZeneca hosted its Q4 ’21 earnings call (press release; slides). Much of the prepared remarks and Q&A focused on the company’s COVID-19 vaccine development, recent Alexion acquisition, and oncology portfolio. The cardiometabolic-related discussion primarily highlighted AZ’s pipeline initiatives in HF and CKD. Of note, AZ did not provide any commentary regarding Roxadustat during the call; however, FENIX will be covering the upcoming FibroGen earnings call anticipated to be held on March 1, 2022. Key points from the AZ Q4 ’21 earnings call are listed below.

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 Q4 ’21 London Earnings; Sanofi and Regeneron Q4 ‘21 and FY ‘21 Earnings Updates

A series of cardiometabolic-related news items have been observed: Novo Nordisk hosted its post-Q4 ’21 earnings event (see previous FENIX insight on Q4 ’21 Novo earnings from February 2); and Sanofi (press release; slides; view infographic) and Regeneron (press release; slides), hosted their respective Q4 and FY ’21 earnings calls. 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, Merck, Roche, and BD Q4 ‘21 and FY ’21 Earnings Updates

A series of cardiometabolic-related news items have been observed: Lannett (press release), Merck (press release; slides), Roche (press release; slides), and BD (press release; slides) hosted their respective Q4 ’21 earnings calls. 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.

Lilly Q4 ‘21 and FY ‘21 Earnings Update

Lilly hosted its Q4 ’21 earnings call (press release; slides) and provided updates across its CVRM portfolio with a particular focus on tirzepatide. Of note, Lilly did not discuss its CVRM pipeline assets including its QW insulin (basal insulin Fc) which is scheduled to enter Ph3 this year. Below are 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.