Tag Archives: cagrisema

Sema on Medicare Negotiation List; STEP UP Topline Results; Long-Term Cagrisema Trial; EMA Reviewing Sema for NAION Risk

A series of cardiometabolic-related news items has been observed by CMS, Novo Nordisk, and EMA. Below, FENIX provides highlights and insights for the respective news items, including thoughts on Novo’s high-dose semaglutide readout.

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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Cagrisema Misses Weight Loss Target

Novo Nordisk announced topline results from its first Ph3 pivotal cagrisema trial (REDEFINE 1; view CT.gov record) demonstrating -22.7% weight loss at Week 68, although Novo projected it would achieve 25%. For context, the trial evaluated cagrisema (a fixed-dose combination of cagrilintide 2.4mg and semaglutide 2.4mg) vs. cagrilintide 2.4mg, semaglutide 2.4mg, and placebo. Novo’s stock decreased by ~20% following the announcement. Below FENIX provides highlights and insights from the REDEFINE 1 trial, including readthrough to other obesity assets in development.

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.

Lexicon Strategic Update; Boston MASH Investor Event; Ypsomed to Manufacture Cargisema Pens; Pep2Tango Obesity Startup; Generic Byetta FDA Approval

A series of cardiometabolic-related news items have been observed from Lexicon Pharmaceuticals, Boston Pharmaceuticals, Ypsomed, Versant Ventures, and Amneal 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.

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Purchase Blast$599.00

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

Novo Q3 ’24 Earnings

Novo Nordisk hosted its Q3 ’24 earnings call (press release; slides) and provided updates across its CVRM portfolio, including new semaglutide PAD data. FENIX will cover Novo’s London Q3 ’24 earnings call tomorrow, November 7, 2024. Below, FENIX provides highlights and insights from the Q3 ’24 earnings 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.

STEP HFpEF Withdrawn; QM GLP/GIP Withdrawn; Novo Q2 ’24 Earnings

Novo Nordisk hosted its Q2 ’24 earnings call (press release; slides) and provided updates across its CVRM portfolio. Importantly, Novo disclosed it has withdrawn the STEP HFpEF sNDA and it discontinued development of its QM GLP/GIP dual agonist, among other updates. FENIX will cover Novo’s London Q2 ’24 earnings call tomorrow, August 8, 2024. Below, FENIX provides highlights and insights from the Q2 ’24 earnings 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.

Kerendia FINEARTS-HF Topline Results; Simplera CGM Approved by FDA; Novo Initiates Second Ph3 H2H Cagrisema vs. Tirzepatide T2DM Study; Ypsomed and MTD Complete BGM Business Sale

A series of cardiometabolic-related news items have been observed from Bayer, Medtronic, Novo Nordisk, and Ypsomed. 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.

Novo to Face Two FDA Adcoms in 2024; Novo Q1 ‘24 Earnings

Novo to Face Two FDA Adcoms in 2024; Novo Q1 ‘24 Earnings

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 Retatrutide CV and Renal Outcomes Study; Novo Initiates New Ph3 Cagrisema Maintenance Dose Study; US Senate Investigates Ozempic/Wegovy Pricing; Teladoc Q1 ’24 Earnings; Vance Swanson Joins Beta Bionics

A series of cardiometabolic-related news items have been observed from Lilly, Novo Nordisk, US Senate HELP Committee, Teladoc, and Beta Bionics. 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.

Novo Initiates Additional Ph3 Cagrisema T2DM Trials; CLEAR Outcomes Approved by FDA and Received Positive CHMP Opinion

Two cardiometabolic-related news items have been observed: Novo Nordisk initiated REIMAGINE 1 (view CT.gov record) and REIMAGINE 3 (view CT.gov record) as the third and fourth trials in its cagrisema T2DM pivotal program; Esperion announced FDA approved CLEAR Outcomes (view press release) and CHMP adopted a positive opinion (view press release). 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.

Novo Nordisk 2024 Capital Markets Day Highlights and Analysis

Novo Nordisk hosted its 2024 Capital Markets Day and provided updates on the strategic direction of the company across key commercial and R&D activities. Below, FENIX provides details and insights from the event.

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.