Category Archives: Dual/triple agonist

New Tirzepatide Injection Device Trial; Novo Partners with Aspect Biosystems; Sanofi’s Provention Bio Acquisition Regulatory Issue; Glooko Partners with Hedia

Four cardiometabolic-related news items have been observed: Lilly initiated a Ph1 tirzepatide trial evaluating a new injection device (view CT.gov record); Novo Nordisk and Aspect Biosystems announced a collaboration, development, and license agreement to develop bioprinted tissue therapeutics for diabetes and obesity (view press release); Sanofi announced it has withdrawn and refiled its Premerger Notification and Report Form under the Hart-Scott-Rodino Act of 1976 (HSR Act) for its pending acquisition of Provention Bio (view press release); and Glooko announced a new global partnership with Hedia (view press release). Below, FENIX provides highlights and insights into the respective news items including thoughts on Lilly’s potential new injection device. 

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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Viking Announces Positive Ph1 GLP-1/GIP Dual Agonist Topline Results and Initiates Oral Formulation Development; Zealand Ph1a Amylin Analog Results; Biomea Ph2 Menin Inhibitor Results

Four cardiometabolic-related news items have been observed: Viking Therapeutics announced positive topline results from the Ph1 SAD/MAD clinical trial evaluating its novel QW subcutaneous GLP-1+GIP dual agonist (VK2735; view press release) and initiated a new Ph1 study for an oral formulation of VK2735 (view press release); Zealand Pharma announced positive results from a Ph1a study of ZP8396, an amylin analog, assessing safety and PK/PD effects in healthy lean and overweight people (view CT.gov record; press release); and Biomea Fusion announced positive topline results for the first two cohorts enrolled in the Ph2 portion of its ongoing Ph1/2 COVALENT-111 study (view CT.gov record) evaluating BMF-219, a covalent menin inhibitor (view press release). Below, FENIX provides highlights and insights into 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.

Mounjaro Obesity Indication Filed in EU; March CHMP Agenda; Vertex Announces T1DM Licensing Agreement with CRISPR; Sanofi Helps Dario Secure Top-Ten PBM Contract

Three cardio-metabolic related news items have been observed: The CHMP agenda (view here) for this month’s meeting (March 27-30) has been released, which includes the new filing of the Mounjaro non-T2DM obesity indication; Vertex announced it has entered into a new non-exclusive licensing agreement with CRISPR Therapeutics for the use of CRISPR’s gene editing technology (view press release); and DarioHealth announced a new contract with an undisclosed top-ten PBM to provide Dario digital therapeutics beginning in Q2 2023 (view press release). Below, FENIX provides highlights and insights from the respective news items, including potential readthrough to the US Mounjaro obesity regulatory strategy.

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 TV DTC Analysis; Intercept OCA Adcom Set

Lilly has launched its first Mounjaro TV DTC with an ad called “What If” (view here). Additionally, Intercept announced FDA formally set an adcom date on May 19, 2023 regarding the ongoing obeticholic acid NDA review for the treatment of NASH. Below, FENIX provides an analysis of the Mounjaro DTC commercial, including thoughts on the timing of the DTC initiation.

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.

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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Purchase Blast$599.00

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

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.

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.

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.

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 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.

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.