Tag Archives: tirzepatide

SURMOUNT-4 Results Published in JAMA; December CHMP Agenda; Fractyl Health Presents GLP-1RA PGTx Findings at WCIRDC 2023

Three cardiometabolic-related news items have been observed: Lilly announced detailed results from SURMOUNT-4 have been published in JAMA (view press release; view publication); the CHMP agenda (view here) for this month’s meeting (December 11-14) has been released; and Fractyl Health presented findings from its Rejuva GLP-1RA-based gene therapy candidate (GLP-1RA PGTx) vs. semaglutide at WCIRDC 2023 in Los Angeles, CA on December 7-9, 2023 (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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Novo Expands Production Facilities in France; Novo to Reduce Production of Victoza for Ozempic Supply; Mounjaro vs. Ozempic in Real-World Study; Kaleido Launches AID System; Biodexa Acquires T1DM Asset; 89bio Long-term MASH Data; Dario Contracts for Cardiometabolic Solution

A series of cardiometabolic-related news items have been observed from Novo Nordisk, Truveta, ViCentra, Biodexa, 89bio, and Dario. Below, FENIX provides highlights and insights for 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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Zepbound (tirzepatide) Label and Website Analysis

FDA recently approved Lilly’s tirzepatide, branded as Zepbound, for the treatment of adults who are obese or overweight with weight-related comorbidities such as hypertension, T2DM, OSA, or CVD (view label; previous FENIX insight). Below, FENIX has conducted a Zepbound label, website, and pricing analysis, including thoughts on Lilly’s innovative targeting of employers.

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 H2H Cagrisema vs. Tirzepatide Trial; Terns and Nemaura Q3 ’23 Earnings; Viking Ph2b MASH Data at AASLD; SAB Therapeutics Raises $67.1M for T1DM Treatment; Dexcom Launches #SeeDiabetes Campaign

A series of cardiometabolic-related news items have been observed from Novo Nordisk, Terns Pharmaceuticals, Nemaura, Viking, SAB Therapeutics, and Dexcom. 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.

Tirzepatide Obesity Indication Approved as “Zepbound” 

Lilly announced that FDA approved tirzepatide as “Zepbound” for adults with obesity or overweight that also have weight-related comorbidities such as hypertension, dyslipidemia, T2DM, OSA, or CVD (view label). Of note, FDA also made an announcement regarding the approval (view here). Tirzepatide remains under review in the EU, UK, China, and other markets. Lilly stated Zepbound is anticipated to be launched in the US by EOY 2023 in six doses (2.5mg, 5mg, 7.5mg, 10mg, 12.5mg, and 15mg). In the press release, Lilly specifically disclosed the Zepbound WAC price of $1,059.87, which Lilly noted is 20% less expensive than Wegovy. FENIX will conduct a full label analysis of Zepbound in the coming days.

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 ’23 Earnings Update

Lilly hosted its Q3 ’23 earnings call (press release; slides) and provided updates across its CVRM portfolio. Management noted the 2024 guidance call will be held in January which is new as the company traditionally hosted these calls in December of the preceding year. 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.

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Purchase Blast$599.00

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Sernova Announces Conformal Coating Technology Advancements; Lilly and BioAge to Initiate Ph2 Tirzepatide Combo Trial; Lilly Partners with Redwire for Cardiometabolic Space Research; EMA Finds No Link Between GLP-1RAs and Thyroid Cancers; Sanofi Invests in MeiraGTx for Gene Regulation Technology

A series of cardiometabolic-related news items have been observed from Sernova, Lilly/BioAge, Lilly/Redwire, EMA, and Sanofi. 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.

SURMOUNT-3 Presented at ObesityWeek; Novo Adds to Its CKD Pipeline; Carmot Presents T2DM/Obesity Results; Better Therapeutics Launches AspyreRx for T2DM

Four cardiometabolic-related news items have been observed: Lilly announced detailed results from SURMOUNT-3, in which tirzepatide demonstrated an additional -21.1% weight loss after 12 weeks of intensive lifestyle management (view press release); Novo Nordisk announced it will acquire an MRA asset from KBP Biosciences for $1.3B (view press release); Carmot Therapeutics presented data from its T2DM/obesity pipeline at the 2023 ObesityWeek conference (view press release); and Better Therapeutics initiated the AspyreRx launch for T2DM (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.

Lilly Initiates Tirzepatide Obesity Trial in Adolescents; Survodutide CVOT Observed; FDA Creates New Digital Health Advisory Committee; Better Therapeutics Announces AspyreRx Subgroup Topline Results; Virta Partners with Navitus for T2DM and Obesity

Five cardiometabolic-related news items have been observed: Lilly initiated a Ph3 study evaluating tirzepatide vs. placebo in adolescents who have obesity or are overweight with weight-related comorbidities (SURMOUNT-ADOLESCENTS; view CT.gov record); BI’s SYNCHRONIZE-CVOT, evaluating survodutide in people with overweight or obesity with CVD, CKD, or at least two risk factors for CVD was observed on CT.gov (view CT.gov record); FDA announced the creation of a new Digital Health Advisory Committee (view press release); Better Therapeutics announced topline results from a subgroup analysis of AspyreRx in T2DM (view press release); and Navitus Health Solutions announced a partnership with Virta Health to make Virta’s T2DM health solutions available to Navitus clients (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.

FDA Approves Jardiance for Adults with CKD; Abbott Completes Bigfoot Acquisition; Insulet Publishes “Market Opportunity & Impact of GLP-1s” Presentation; Lilly initiates Ph3 H2H Orforglipron vs. Semaglutide and New Ph3b Tirzepatide Max Dose Study in Obesity

A series of cardiometabolic-related news items have been observed from BI/Lilly, Abbott, Insulet, and Lilly. 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.