Category Archives: GLP-1RA

Novo Sues Orbicular Pharmaceuticals Over Generic Saxenda; Sema Ph2 NASH Trial Disappoints; Kerendia Receives New Recommendations from ADA; Sanofi Cuts Insulin Price and Partners with Direct Relief; Novartis to Cut 8,000 Jobs Worldwide; Lifescan Publishes Connected BGM RWE

A series of cardiometabolic-related news items have been observed from Novo Nordisk, Bayer, Sanofi, Novartis, and Lifescan. 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 to Initiate Ph1 Sema+Dapa FDC Ph1 Trial; ProKidney Publishes Data Supporting MoA of REACT in Patients with Diabetic CKD; Cytokinetics Announces Date for Omecamtiv FDA Adcom; Hygieia licenses d-Nav program in Israel

A series of cardiometabolic-related news items have been observed: a two-part Ph1 Novo-sponsored study evaluating a semaglutide/dapagliflozin FDC has been observed (view CT.gov record); ProKidney recently announced the publication of data from an MoA study of its Renal Autologous Cell Therapy (REACT) in Kidney International Reports (view publication here); Cytokinetics announced FDA informed the company the omecamtiv adcom has been scheduled for December 13, 2022; and Hygieia announced it licensed its d-Nav insulin management system to Movement Group in Israel. 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.

Zealand Presents Ph1 Dapiglutide Trial Data; Novo and GluCare Partnership for Innovative Weight Management Program; Ginkgo and Novo Collaboration on Expression Systems; Sanofi launches first Digital Accelerator

Four cardiometabolic-related news items have been observed: Zealand recently announced results from its Ph1b GLP-1/GLP-2 dapiglutide; GluCare.Health announced a partnership with Novo Nordisk for an innovative weight management pilot program to launch in September; Ginkgo Bioworks recently announced a collaboration with Novo Nordisk to create new expression hosts for pharmaceutical products using synthetic biology; and Sanofi recently announced the launch of its first Digital Accelerator. 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.

Thoughts after ATTD and ADA 2022

Now that we’re on the other side of ADA 2022, FENIX provides provocative thoughts below on various items in the cardiometabolic space. Included are thoughts about Lilly, Novo, Sanofi, Dexcom, Abbott, Medtronic, Bigfoot, and Beta Bionics.

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 ADA 2022 Investor Call

Lilly hosted an ADA 2022 investor event in which the company covered tirzepatide SURMOUNT-1 trial results, tri-agonist GGG, oral incretins, and a summary slide of Lilly’s CVRM R&D portfolio (view slides). Prior to the call, during the morning session at ADA 2022, it was publicly disclosed that Lilly will be conducting SURPASS-EARLY, thought to be a long-term trial investigating the durability of glycemic control in T2DM for tirzepatide vs. placebo in addition to SOC. 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.

Novo Hosts ADA 2022 Investor Event

Novo Nordisk hosted its 2022 ADA investor event primarily focusing on its obesity and QW insulin portfolio (view slides). Of note, management emphasized GLP-1RA class growth, SELECT’s upcoming interim analysis, plans to study even higher doses of semaglutide in T2DM, and the feasibility of a cagrisema H2H trial vs. tirzepatide. 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.

ADA 2022 Key Press Releases (June 4)

On the second day of ADA 2022, six cardiometabolic-related news items were observed from Lilly, ADA, Insulet, vTv Therapeutics, and One Drop. Below, FENIX provides context and analysis for the announcements.

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.

Mounjaro WAC Pricing Analysis; Lilly @ UBS 2022

Late last week, Lilly disclosed Mounjaro will be offered at $974.33 WAC across all available doses. Additionally, during Lilly’s fireside chat at UBS 2022 (view replay), Mike Mason, Lilly’s SVP and President of Diabetes briefly commented on Lilly’s pricing rationale for tirzepatide (discussed below). As a follow-up to FENIX’s Mounjaro label and website analysis (previous FENIX insight), FENIX has conducted a Mounjaro pricing analysis, including insight into why Lilly may opt to create a second brand for the tirzepatide obesity indication.

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.

Mounjaro (tirzepatide) Label and Website Analysis

Late last week, FDA approved Lilly’s tirzepatide, branded as Mounjaro (mown-JAHR-OH), for the treatment of adults with T2DM (view label; previous FENIX insight). Below, FENIX has conducted a label and website analysis, including potential insight into the Mounjaro launch.

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 to Acquire Zealand’s V-Go T2DM Patch Pump; Sernova/Evotec Collaboration for Beta Cell Therapy; AACE Updates NAFLD Guidelines

Three cardiometabolic-related news items have been observed: MannKind announced plans to acquire Zealand’s V-Go insulin delivery device; Sernova and Evotec announced an exclusive global strategic partnership to develop an implantable iPSC-based beta cell replacement therapy and hosted an associated investor call (listen to webcast here); and AACE has updated its NAFLD practice guidelines which favor GLP-1RAs (view guidelines). 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.