Category Archives: GLP-1RA

Tirzepatide Approved in US as “Mounjaro”

FDA announced it has approved Lilly’s tirzepatide as “Mounjaro” for the treatment of adults with T2DM. Recall, Lilly filed the tirzepatide T2DM BLA with a PRV in October 2021 (previous FENIX insight) which allowed for a 6-month review. Tirzepatide remains under review in the EU. The label has not yet been observed at the time of this publication. FENIX will conduct a full label analysis of tirzepatide in the coming days once the label is available.

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 Q1 ’22 London Earnings; Lilly Initiates Second Trial in Ph3 QWINT Program; Ionis, Provention Bio, Lexicon, and Lannett Q1 ’22 Earnings Updates

A series of cardiometabolic-related news items have been observed: Novo Nordisk hosted its post-Q1 ’22 earnings event (see previous FENIX insight on Q1 ’22 Novo earnings from April 29); a second trial from Lilly’s Ph3 QW insulin program (BIF; LY3209590) has been observed (view CT.gov record); Lexicon (press release), Ionis (press release; slides), Provention Bio (press release), and Lannett (press release) hosted their respective Q1 ‘22 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.

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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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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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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.

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Purchase Blast$599.00

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

Ozempic 2.0mg Approved by FDA

Novo Nordisk announced its 2.0mg dose of Ozempic has been approved by FDA (view label), which is in line with FENIX’s projection. Recall, on May 28, 2021, Novo announced it resubmitted the sNDA to FDA following a Refusal to File Letter in January 2021 (previous FENIX insight). Of note, Novo indicated plans to launch 2.0mg Ozempic in Q2 ’22. Below, FENIX provides brief thoughts on the 2.0mg Ozempic approval.

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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Abbott Sponsors YouTube Video; Novo-Novartis Generic Victoza Suit Settled; Dario Q4 and FY ’21 Earnings; Signs Two New Employer Contracts

A series of cardiometabolic-related news items have been observed: An Abbott-sponsored YouTube video highlighting several of Abbott’s devices was recently posted by YouTube creator UrAvgConsumer (view video); it has been reported that Novo Nordisk and Novartis’s Sandoz have settled their generic Victoza patent infringement lawsuit (view article); and Dario hosted its Q4 and FY ’21 earnings call (press release) and announced two additional new employer contracts (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.

Rockley Photonics and Medtronic Collaboration for Non-invasive Wearables; Gan & Lee Dose First Patient with GZR18 in Ph1 T2DM Study; Xeris Biopharma and Zealand Q4 and FY ‘21 Earnings Updates

A series of cardiometabolic-related news items have been observed: Rockley Photonics Holdings Limited announced a development partnership with Medtronic to integrate Rockley’s Bioptx biomarker sensing platform with Medtronic’s devices across various healthcare settings; Gan and Lee announced the first patient has been dosed in their Ph1 study evaluating the company’s investigational GLP-1RA (GZR18) in T2DM; and Zealand (press release; slides) and Xeris (press release) hosted their respective 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.

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Purchase Blast$599.00

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

Novo Nordisk Expands Research Collaboration for Oral Drug Delivery Technologies; eGenesis and University of Miami Collaboration for Human-Compatible Islet Cells

Two cardiometabolic-related news items have been observed: Novo Nordisk announced it will be expanding its existing research collaboration for oral drug delivery technologies with MIT and Brigham and Women’s Hospital; and eGenesis announced a research collaboration with the University of Miami Leonard M. Miller School of Medicine to evaluate gene-edited pancreatic human-compatible islet cells in T1DM. 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.