Category Archives: GLP-1RA

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.

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Kailera Raises $600M for its Ph3 Obesity Program

Kailera Therapeutics announced a $600M Series B financing, with plans to initiate its global Ph3 program of KAI-9531 (QW SC GLP-1/GIP dual agonist) by YE 2025. Kailera completed an end-of-Ph2 meeting with FDA and discussed the Ph3 program, which will evaluate KAI-9531 in adults with obesity or overweight with and without T2DM. The company is also planning a trial in adults with a BMI of 35 or higher. For context, in May 2024, Kailera acquired exclusive global rights to develop and commercialize HRS9531 from Hengrui outside of greater China as KAI-9531 (previous FENIX insight). Below, FENIX provides highlights and insights for the news item.

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 Cuts Cell Therapy R&D Division; FDA Accepts Afrezza Peds sBLA; Ascletis Selects Obesity Candidate; Lilly Initiates Ph2 Macupatide and Eloralintide Trial; October CHMP Agenda 

A series of cardiometabolic-related news items has been observed from Novo Nordisk, MannKind, Ascletis Pharma, Lilly, 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.

Ypsomed Builds US Manufacturing Site; Eccogene Eyes Hong Kong IPO; Former Novo CEO Joins Healthcare Denmark

Three cardiometabolic-related news items have been observed: Ypsomed announced an investment of $248M for a US manufacturing site (view press release); Eccogene filed an IPO on the Hong Kong Stock Exchange (view article; view prospectus); and Lars Fruergaard Jørgensen was appointed Chair of Healthcare Denmark (view LinkedIn post; 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 Acquires Akero for EFX in MASH

Novo Nordisk and Akero Therapeutics announced they have entered into a definitive acquisition agreement for Novo to acquire Akero for an upfront payment of $4.7B, with a total deal value up to $5.2B. An associated call was held following the announcement (view webcast; view slides). For context, Akero’s lead asset, efruxifermin (EFX; FGF21) is currently in Ph3 development for the treatment of MASH. Below, FENIX provides highlights and insights from the deal in the context of Novo’s organizational changes. 

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.

Ed Cinca Rejoins Novo as SVP of US Marketing; Skye’s CB1 Ph2a Dose Suboptimal; Amgen Launches its DTP Program; Wegovy Pill Available DTP via Telehealth; Costco Sells Ozempic and Wegovy; Libre Featured on ESPN; Lilly Partners with Local Manufacturers in India

A series of cardiometabolic-related news items has been observed from Novo Nordisk, Skye Bioscience, Amgen, Abbott, 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.

New Orforglipron SUI Trial; Amgen VESALIUS-CV Results; EASO Recommends GLP-1RAs

Three cardiometabolic-related news items have been observed: Lilly initiated the Ph3 RESTRAIN-SUI study investigating orforglipron (QD oral GLP-1RA) in female participants with obesity or overweight and stress urinary incontinence (SUI; view CT.gov record); Amgen’s Repatha met primary endpoints for its Ph3 VESALIUS-CV trial in a primary prevention population (view press release); and EASO published a framework for obesity management, recommending semaglutide and tirzepatide as first-line AOMs (view publication). 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.

Alnylam/Roche Initiate Zilebesiran CVOT; Hanmi Files Obesity IND; Sagimet Ph1 MASH Study

Three cardiometabolic-related news items have been observed: Alnylam/Roche dosed the first patient in the Ph3 ZENITH CVOT study evaluating zilebesiran in uHTN (view press release); Hanmi Pharmaceuticals filed an IND for its muscle-sparing obesity candidate (view press release); and Sagimet Biosciences dosed the first participants in its Ph1 study of denifanstat + resmetirom (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.

Metsera Ph2b VESPER Results; NovoCare Partners with LifeMD; Novo Terminates CV Partnership; MindRank Ph1b Obesity Results; Cascade Initiates Ph2 MASH Study

A series of cardiometabolic-related news items has been observed from Metsera, Novo Nordisk, HeartSeed, MindRank, and Cascade 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.

Novo Resubmits Icodec BLA; BI and Novartis Launch DTP Platforms; t:slim X2 + Control-IQ+ Now Compatible with Lyumjev

Three cardiometabolic-related news items have been observed: Novo Nordisk resubmitted the Awiqli (insulin icodec) BLA but only for adults with T2DM (view press release); Boehringer Ingelheim (view press release) and Novartis (view press release) separately announced creation of DTP platforms; and Tandem Diabetes Care announced t:slim X2 with Control-IQ+ is now compatible with Lilly’s Lyumjev (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.