Tag Archives: Lilly

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.

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Zealand to Receive PRV?; Zealand Q3 ’25 Earnings; Pfizer Completes Metsera Acquisition; WeightWatchers to Offer Oral Wegovy; Ascletis Preclinical Combination Data; MangoRx Partners with NovoCare and LillyDirect? 

A series of cardiometabolic-related news items has been observed from Pfizer/Metsera, Zealand Pharma, WeightWatchers, Ascletis Pharma, and Lilly/Mangoceuticals (MangoRx). Below, FENIX provides highlights and insights for the respective news items, including how Zealand can use a PRV to decrease the review time of petrelintide.

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.

Skye Q3 ‘25 Earnings; Lilly Partners for Obesity Awareness; Coramitug Ph2 Data Published; Madrigal, Sagimet, and Galectin MASH Data at AASLD 2025 

A series of cardiometabolic-related news items has been observed from Skye Bioscience, Lilly, Novo Nordisk/Prothena, Madrigal Pharmaceuticals, Sagimet Biosciences, and Galectin Therapeutics. 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.

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.

Insulet, Altimmune, Gubra, Tandem, and Structure Q3 ’25 Earnings; Cagrisema Data at ObesityWeek 2025; MetaVia and Altimmune MASH Results at AASLD 2025; New Lilly Obesity Asset 

A series of cardiometabolic-related news items has been observed from Insulet, Altimmune, Novo Nordisk, Gubra, Tandem Diabetes Care, Structure Therapeutics, MetaVia, and Lilly. 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.

Pfizer and Novo Up Metsera Bids; Pfizer, Amgen, Madrigal, and Vertex Q3 ’25 Earnings; Hims in Talks with Novo

A series of cardiometabolic-related news items has been observed from Pfizer/Metsera/Novo, Amgen, Madrigal Pharmaceuticals, Vertex Pharmaceuticals, and Hims & Hers. 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.

Pfizer/Novo Battle Escalates; Lilly Registers Another ORC Study; New Lilly Orfor Manufacturing Site; GSK Ph3 MASH Program  

A series of cardiometabolic-related news items have been observed from Pfizer/Metsera, Lilly, and GSK. 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 ‘25 Earnings; Raises FY 2025 Guidance 

Lilly hosted its Q3 ‘25 earnings call (press release; slides) and provided updates across its CVRM portfolio. Of note, the company’s stock is up 5% after raising its FY 2025 sales guidance from $60.0-62.0B to $63.0-63.5B due to strong underlying performance across its portfolio, including Zepbound and Mounjaro. 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.

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.

Beta Bionics Q3 ’25 Earnings; Lilly Partners with Walmart & Invests in Oral Manufacturing; Tandem Integrates with Libre 3+; More Novo Leadership Changes

A series of cardiometabolic-related news items have been observed from Lilly, Beta Bionics, Tandem Diabetes Care, 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.