Tag Archives: Wegovy

Lilly’s Ph3 ATTAIN-MAINTAIN Results; Orforglipron Filed; Novo Files Cagrisema and Receives FDA Warning Letter; Merck to Receive CNPV; SAB BIO Pivotal Ph2b T1DM Trial; Sagimet Enters Agreement for Resmetirom

A series of cardiometabolic-related news items has been observed from Lilly, Novo Nordisk, Merck, SAB Biotherapeutics, and Sagimet Biosciences. Below, FENIX provides highlights and insights for the respective news items, including what Sagimet could be thinking vs. Madrigal.

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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FDA Leadership Pushes for Expedited Orforglipron Review; Novo and Cytokinetics Positive CHMP Opinions; Rezolute Misses Endpoints in Ph3 Study

A series of cardiometabolic-related news items has been observed from Lilly, Novo Nordisk, Rezolute, and Cytokinetics. 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 Files 7.2mg Wegovy; CMS Cuts Semaglutide Prices; FDA Publishes Marketing Violation Letters

Three cardiometabolic-related news items have been observed: Novo Nordisk submitted its sNDA to FDA for high-dose (7.2mg) Wegovy in obesity (view press release); CMS announced the negotiated prices from the second round of IRA discussions, including Novo’s semaglutide (view press release; view fact sheet); and FDA published promotional activity violation letters from the OPDP (view letters). Below, FENIX provides highlights and insights for the respective news items, including the projected approval timeline for high-dose Wegovy in the US.

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 Reduces Wegovy and Ozempic US DTP Pricing

Novo Nordisk announced that effective today (November 17), it is reducing the US cash-pay price of injectable Wegovy and Ozempic to $199/month for the first two months and $349/month for subsequent months (down from $499/month). Below, FENIX provides insight into Novo’s pricing updates, including a curious observation (and hypothesis) regarding the 2.0mg Ozempic dose.

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.

Obesity CNPV Analysis: Novo Changes Strategy, but Lilly Set to Win

As part of Novo and Lilly’s recent MFN deals (previous FENIX insight), both received a Commissioner’s National Priority Voucher (CNPV), potentially accelerating the review time of a product to only 1-2 months. Novo and Lilly disclosed plans to use their CNPVs for 7.2mg semaglutide and orforglipron, respectively. Below, FENIX provides thoughts on each of the CNPVs, including why Lilly is positioned to benefit the most.

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.

Pfizer Wins Metsera Bidding War; Lilly Partners for RNAi Drug Discovery; AZ Acquires Obesity Start-Up; Tandem’s Mobi Cleared for Android Use; Merck, Amgen, AZ, Ionis Data at AHA 2025; November CHMP Agenda 

A series of cardiometabolic-related news items have been observed from Metsera/Pfizer, Lilly, AstraZeneca, Tandem Diabetes Care, Merck, Amgen, Bayer, Ionis Pharmaceuticals, Camurus, and EMA. 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 and Pfizer Up Metsera Bids…Again; Novo/Lilly Strike MFN Deal; Lilly Ph2 Amylin Data; Viking Presents VK2735 Data at ObesityWeek; AstraZeneca Q3 ’25 Earnings

A series of cardiometabolic-related news items has been observed from Novo Nordisk, Lilly, Viking Therapeutics, and AstraZeneca. 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 Q3 ’25 Earnings; Lowers FY 2025 Guidance…Again

Novo Nordisk hosted its Q3 ’25 earnings call (press release; slides) and provided updates across its CVRM portfolio and obesity pipeline. Of note, the company has lowered its FY 2025 sales growth guidance again from 8-14% to 8-11% due to continued underperformance of its semaglutide franchise. Recall, at the beginning of the year, Novo originally guided that FY 2025 sales growth would be in the range of 16-24% (view slide). Below, FENIX provides highlights and insights from the Q3 ’25 earnings call, including thoughts on the Metsera acquisition saga.

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.

Obesity Spotlight: How Will Lilly Maintain Market Leadership?

In the ninth installment of FENIX’s Obesity Spotlight Series, FENIX has conducted a deep dive analysis of Lilly’s current position in the obesity market. The analysis includes insights into Lilly’s strategy to maintain a broad portfolio to stay at the top ahead of the impending wave of obesity competitors.

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.

EASD 2025 Key Press Releases (September 16) 

On the second day of EASD 2025, five key news items were observed from Novo Nordisk, Roche, Tandem Diabetes Care, and Cantoni Therapeutics. Below, FENIX provides context and analysis for the announcements.

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.