Category Archives: SGLT2i

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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Did Lilly Cure Obesity? SURMOUNT-1 Topline Results; Q1 ‘22 Earnings Updates

Lilly hosted its Q1 ’22 earnings call (press release; slides) and provided updates across its CVRM portfolio. Prior to the earnings call, Lilly announced highly positive topline results from the first Ph3 tirzepatide obesity study (SURMOUNT-1) which demonstrated up to 22.5% weight loss (press release). In prepared remarks, management briefly discussed other CVRM-related topics, including regulatory approvals of EMPEROR-Preserved (previous FENIX insight), the initiation of its QW insulin Ph3 program (QWINT-3; previous FENIX insight), and early termination of EMPA-KIDNEY (previous FENIX insight). Importantly, Lilly confirmed it purchased a PRV in Q1 ’22. 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.

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Purchase Blast$599.00

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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.

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Purchase Blast$599.00

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

New Medtronic 780G + Lyumjev Trial; Xigduo XR DAPA-CKD sNDA approved; Galectin NASH Trial to Continue; Sciwind Initiates Ph1 Oral GLP-1RA Trial

A series of cardiometabolic-related news items have been observed: a Medtronic-sponsored study evaluating the use of Lilly’s Lyumjev in the MiniMed 780G AID system has been observed (view CT.gov record); the Xigduo XR (dapagliflozin + metformin) DAPA-CKD sNDA has recently been approved (view updated label); Galectin Therapeutics reported positive feedback from its first DSMB meeting for its Ph2b/3 NAVIGATE study evaluating belapectin in NASH (press release); and Sciwind Biosciences announced it has started dosing patients in its Ph1 MAD study evaluating the company’s investigational oral GLP-1RA (XW004; ecnoglutide) in healthy volunteers. 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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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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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.

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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.

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Purchase Blast$599.00

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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.