Tag Archives: Zepbound

Zepbound OSA Label and Website Analysis

FDA recently approved the Zepbound label expansion to treat moderate-to-severe obstructive sleep apnea (OSA) in adults with obesity (view label; previous FENIX insight). The label expansion is based on Lilly’s Ph3 SURMOUNT-OSA trial evaluating tirzepatide in participants with OSA and obesity (view publication; previous FENIX insight). Below, FENIX has conducted an analysis of the updated Zepbound label and patient/HCP/employer websites.

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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Holiday Hangover: FDA Approves Zepbound for OSA; NICE Finalizes Tirzepatide Guidelines; Abbott and Dexcom Reach Agreement; Arrowhead Ph1/2a ARO-INHBE Trial in Obesity; AZ Initiates Ph2 MASH Trial; Zealand Petrelintide Commentary; Generic Liraglutide Approvals; Lexicon Receives CRL for Zynquista

During the holiday break, a series of cardiometabolic-related news items were observed from Lilly, NICE, Dexcom/Abbott, Arrowhead Pharmaceuticals, AstraZeneca, Zealand Pharma, Biocon/Hakima, and Lexicon Pharmaceuticals. 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.

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/EASD 2025 Guidelines; Ro/Lilly Zepbound SDV Partnership; Tirzepatide for Addiction Treatment

Three cardiometabolic-related news items have been observed: Updated ADA/EASD guidelines for 2025 have been released (view guidelines; view revisions); Lilly and Ro partnered for Zepbound single-dose vials (view press release); and Lilly announced potential plans for tirzepatide for treatment of addiction and inflammation (view article; view interview). 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.

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.

UK Tirzepatide Rollout Plan; Lilly and Amgen Expand Manufacturing Facilities; New Novo GLP-1/GIP RA CKD and Obesity Trials; Insulet Defends US Patent from EOFlow

A series of cardiometabolic-related news items have been observed from NICE, Lilly, Amgen, Novo Nordisk, and Insulet. 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.

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.

Zepbound Beats Wegovy in H2H Study; Novavax to Sell Manufacturing Facility to Novo; Antag $84M Series A Financing for Ph1 Obesity Trial

Three cardiometabolic-related news items have been observed: Lilly announced topline data from its SURMOUNT-5 trial where Zepbound was associated with higher weight loss compared to Wegovy (view press release); Novavax is selling a Czech manufacturing facility to Novo Nordisk (view press release); and Antag Therapeutics announced a $84M Series A financing round to support its QW SC GIPR antagonist for the treatment of obesity (view press release). Below, FENIX provides highlights and insights for the respective news items, including thoughts and implications of the H2H Zepbound vs. Wegovy data.

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 Zepbound DTC Observed; New Novo Insulin Trial; Amgen Damage Control; Lexicon, Fractyl, and Terns Q3 ‘24 Earnings; Metsera Series B Financing; G&L Oral GLP-1RA Data

A series of cardiometabolic-related news items have been observed from Lilly, Novo Nordisk, Amgen, Lexicon Pharmaceuticals, Fractyl Health, Terns Pharmaceuticals, Metsera, and Gan & Lee. 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.

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 ’24 Earnings Call

Lilly hosted its Q3 ’24 earnings call (press release; slides) and provided updates across its CVRM portfolio. Of note, Lilly decreased its FY2024 revenue guidance by $600M to $45.4B- $46B, primarily due to the acquired IPR&D charges incurred in Q3 as well as investments in increasing the supply of tirzepatide. Following the updated guidance, Lilly’s stock price decreased by ~8%.

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.

Dexcom and Sanofi Q3 ’24 Earnings; Zepbound Label Update

Three cardiometabolic-related news items have been observed: Dexcom hosted its Q3 ’24 earnings call (press release; slides); the Zepbound US label has been updated to include SURMOUNT-3 and -4 data (view label); and Sanofi hosted its Q3 ’24 earnings call (press release; slides; infographic). 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.

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 Launches Single-Dose Zepbound Vials; Omnipod 5 T2DM Approval; Novo Semaglutide Adolescent Obesity Study

A series of cardiometabolic-related news items have been observed from Lilly, Insulet, and Novo Nordisk. 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.

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 Raises FY Guidance by $3B; Lilly Q2 ’24 Earnings; Novo Q2 ’24 London Event

Two cardiometabolic-related news items have been observed: Lilly hosted its Q2 ’24 earnings call (press release; slides) and raised its FY2024 revenue guidance by $3.0B; and Novo Nordisk hosted its post-Q2 ’24 earnings London analyst event (view webcast). Below, FENIX provides highlights and insights for the respective calls.

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.