Category Archives: SGLT2i

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.

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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.

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Purchase Blast$599.00

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

EMPA-KIDNEY Stopped Early; Bayer Files FIGARO-DKD in EU; Glooko Acquires DIABNEXT; Oramed Completes Ph2 Oral Insulin NASH Enrollment; Better Therapeutics Announces BT-001 Pivotal Trial Data in T2DM

A series of cardiometabolic-related news items have been observed from BI/Lilly, Bayer, Glooko, Oramed, and Better Therapeutics. 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.

Know Labs Prepares for FDA Pre-submission Meeting; FDA Accepts Inventiva’s IND for Ph2 Combination (lanifibranor+empa) Trial; Dexcom CGMs Integrated With Happy Bob

Three cardiometabolic-related news items have been observed: Know Labs issued a press release outlining its planned activities ahead of an FDA pre-submission meeting for its non-invasive Bio-RFID technology (press release); Inventiva announced that FDA has accepted Inventiva’s IND for its Ph2 combination lanifibranor+empa trial (LEGEND) in NASH +T2DM; and Harald AI announced that its subscription-based, diabetes management app, Happy Bob, has been integrated with Dexcom CGMs. 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.

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.

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 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.

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-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.

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 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.

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.

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.

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 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.

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.