Category Archives: Dual/triple agonist

Abbott Q4 ’22 Earnings; Tidepool Loop Receives FDA Clearance; Lilly to Expand Incretin Manufacturing Capacity; Novo Receives Marketing Practices Complaint; AGC Biologics to Manufacture Tzield; Nemaura Reports Positive Miboko Data; J&J Q4 ’22 Earnings; and Embecta Opens New Headquarters

A series of cardiometabolic-related news items were observed from Tidepool, Lilly, Novo, Embecta, AGC Biologics, and Nemaura. Additionally, Abbott and J&J hosted Q4 ’22 earnings calls. Below, FENIX provides highlights and insights into the respective news items including commentary on why the claims against Novo’s marketing practices seem unfounded.

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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Lilly Green Lights Two Next-Gen Incretin Ph3 Programs; Lilly 2023 Guidance Call

Lilly hosted its 2023 guidance call (slides; webcast) and provided key pipeline updates and an overview of potential upcoming milestones. Importantly, Lilly announced plans to advance its GGG tri-agonist (retatrutide) and oral GLP-1R NPA (orfoglipron) into Ph3 development. Additionally, Lilly disclosed that the final pivotal QW insulin trial (QWINT-1) will evaluate a fixed dose using the same Mounjaro/Trulicity auto-injector. Below, FENIX provides highlights and insights from the event including a readthrough to new obesity development entrants, specifically Pfizer and Amgen.

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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Amgen AMG 133 Updates @ WCIRDC 2022; Novo Initiates Ph3 Ziltivekimab Trial in HF

Two cardiometabolic-related news items have been observed: Amgen presented AMG 133 Ph1 data at WCIRDC and hosted an associated call with investors to discuss future development plans (press release; slides); and Novo has initiated a Ph3 trial (HERMES) evaluating the efficacy of ziltivekimab in patients with heart failure (LVEF >40%) and inflammation (view CT.gov record). Below, FENIX provides highlights and insights from the respective news items, including thoughts on how AMG 133 fits into the evolving obesity treatment market.

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.

Lilly Q3 ’22 Earnings Update

Lilly hosted its Q3 ’22 earnings call (press release; slides) and provided updates across its CVRM portfolio. Unsurprisingly, much of the call was focused on the Mounjaro US launch, manufacturing capacity considerations, and LCM initiatives. Other topics highlighted during the call included the ongoing QW insulin Ph3 program (QWINT), recent Tempo Smart Button US/EU regulatory approvals, and ANGPTL-3 siRNA advancement into Ph2. 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.

Tirzepatide Receives Fast Track Designation in Obesity; Provention Bio and Sanofi Join Forces for Potential Teplizumab US Launch

Two cardiometabolic-related news items have been observed: Lilly announced FDA granted Fast Track designation for the investigation of tirzepatide in adults that are obese or overweight with weight-related comorbidities; and Provention Bio and Sanofi US announced a co-promotion agreement for the commercialization of teplizumab in the US. 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.

Tirzepatide Approved in Japan; Nemaura and EVERSANA Partner for BEATdiabetes; SURMOUNT-MMO Trial Record Posted

Three cardiometabolic-related news items have been observed: Lilly announced tirzepatide is approved in Japan (press release); Nemaura announced a preliminary commercialization agreement with EVERSANA for BEATdiabetes (press release); and Lilly’s Ph3 tirzepatide obesity outcomes trial (SURMOUNT-MMO) has been posted on CT.gov (view CT.gov record). Below, FENIX provides highlights and insights from the respective news 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.

SURMOUNT-MMO Trial Design Presented at EASD 2022

At EASD 2022, Lilly presented a high-level overview of the SURMOUNT-MMO clinical trial design during a session titled “Overcoming challenges in obesity medicine: The SURMOUNT Clinical Development Program” (view session; sign-in required). SURMOUNT-MMO has not yet been posted to CT.gov. Below, FENIX provides an overview of the SURMOUNT-MMO trial design and insights, including key differences with Novo’s SELECT trial.

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.

Akero Becomes a Frontrunner in NASH; Lilly Initiates Tirzepatide Ph2 TREASURE-CKD Trial; Oramed’s Oral Insulin Ph2 NASH Topline Results

Three cardiometabolic-related news items have been observed: Akero announced positive topline results from its Ph2b HARMONY trial evaluating QW efruxifermin (EFX) in pre-cirrhotic NASH (view CT.gov record); Lilly’s Ph2 tirzepatide CKD trial (TREASURE-CKD) has been observed (view CT.gov record); and Oramed announced positive topline results from its Ph2 trial evaluating ORMD-0801 in T2DM and NASH. Below, FENIX provides highlights and insights from the respective news 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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FENIX Analysis: Mounjaro Launch Update

Following approval of Lilly’s Mounjaro (tirzepatide) in T2DM in May 2022 (previous FENIX insight), FENIX has conducted an initial launch analysis, including early insights from prescription trends as well as a look into the Mounjaro promotional, sampling, and copay card tactics.

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.

Thoughts on SURMOUNT-MMO after SELECT Interim Analysis

At its Q2 ’22 earnings in August, Novo Nordisk disclosed that SELECT, the Wegovy CVOT, would not stop for overwhelming efficacy at a pre-specified interim analysis (previous FENIX insight). With all the hype now passed, the trial design lens turns to Lilly’s tirzepatide obesity CVOT, SURMOUNT-MMO. Below, FENIX provides thoughts on SURMOUNT-MMO, including Lilly’s potential strategy to get a broad metabolic indication, similar to what BI/Lilly did in HF with Jardiance by eliminating LVEF label language.

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.