Category Archives: Dual/triple agonist

Lilly Initiates Ph3 Retatrutide Obesity Program; UnitedHealthcare Expands Coverage to Eversense E3 CGM

Two cardiometabolic-related news items have been observed: Lilly initiated the first trial in the Ph3 retatrutide obesity program (TRIUMPH-3; view CT.gov record); and Senseonics announced UnitedHealthcare will cover the Eversense E3 CGM starting July 1, 2023, for T1DM and insulin-requiring T2DM patients. Below, FENIX provides highlights of the respective news items, including insight into the potential retatrutide Ph3 TRIUMPH program and Lilly’s strategy for an obesity CVOT.  

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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Senate Targets PBMs and Insulin Manufacturers; Zealand and Dario Q1 ’23 Earnings; Cytokinetics Initiates Ph1 Trial for Potential HFpEF Therapy

Four cardiometabolic-related news items have been observed: On May 10, 2023, the Senate Committee on Health, Education, Labor, and Pensions (HELP) held a widely covered hearing with Sanofi, Lilly, and Novo Nordisk’s CEOs as well as executives from top PBMs (view broadcast here); Zealand Pharma (view press release; slides) and Dario (press release) hosted their respective Q1 ‘23 earnings calls; and Cytokinetics announced the initiation of a Ph1 trial evaluating CK-4021586 (CK-586) as a potential treatment for HFpEF (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

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BI and Zealand Announce Positive Ph2 BI 456906 Obesity Results; Senseonics and MannKind Q1 ’23 Earnings; Sanofi Study Demonstrates Benefit of Dario; MyFitnessPal and Google Health CGM Integration; Diamyd’s Remygen Fails To Support Durable Treatment Effect

A series of cardiometabolic-related news items have been observed from BI and Zealand, Dario and Sanofi, MyFitnessPal and Google Health, and Diamyd Medical. Additionally, Senseonics and MannKind hosted their respective Q1 ’23 earnings calls. 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.

Lilly to Use PRV for Tirzepatide Obesity Submission Following Positive SURMOUNT-2 Topline Results; Lilly, Viking, and Teladoc Q1 ’23 Earnings

Four cardiometabolic-related news items have been observed: Lilly announced tirzepatide’s SURMOUNT-2 trial showed -15.7% weight loss in obese adults and said it will use a PRV for an obesity PDUFA date by YE 2023 (view press release); and Lilly (press release; slides), Viking Therapeutics (press release) and Teladoc Health (view press release; slides) hosted their respective Q1 ’23 earnings calls. 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.

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 Initiates SURMOUNT H2H Obesity Trial vs. Wegovy; Lannett Delisted from NYSE; Novo Initiates Ph3 Icodec ONWARDS 9 CGM Trial; Senate Targets PBMs

A series of cardiometabolic-related news items have been observed: Lilly has initiated a fifth trial in the Ph3 SURMOUNT obesity program evaluating tirzepatide vs. Wegovy in non-T2DM obese patients (SURMOUNT-5; view CT.gov record); Lannett announced NYSE has commenced proceedings to delist its common stock (view press release); Novo Nordisk has initiated a Ph3 trial evaluating flash glucose monitoring based titration of QW insulin icodec in insulin-naïve T2DM participants (ONWARDS 9; view CT.gov record); the Senate Finance Committee has released a framework to target PBMs and reduce drug costs for patients and taxpayers (view here); and Senator Bernie Sanders’s team announced that the Senate Health, Education, Labor, and Pensions (HELP) Committee will hold a hearing on Wednesday, May 10, at 1:00 PM EST where the CEOs of Lilly, Novo, Sanofi, and senior executives from major PBMs will testify (view article). 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.

Lilly Completes SURMOUNT-2 Trial; FDA Clears Libre 3 Reader; Novo Initiates Ph3 Icodec + Semaglutide Treatment Intensification Trial

Three cardiometabolic-related news items have been observed: On April 13, 2023, the ClinicalTrials.gov record for SURMOUNT-2 was updated to reflect that the trial has been completed; Abbott announced FDA cleared a standalone reader for its FreeStyle Libre 3 iCGM system (view press release); and Novo Nordisk has initiated a Ph3 T2DM trial evaluating icodec as add-on therapy to semaglutide for treatment intensification (view CT.gov record). 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.

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.

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.

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.

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.

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 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.