Tag Archives: KAI-9531

Kailera Initiates Another Ph2 Ribupatide Study; Ascletis Reports Topline Ph2 Data; Laekna Announces Topline Ph1 Data; Glooko Connects with Roche’s CGM; SK pharmteco to Manufacture Long-Acting API for Current Lilly Product; Novo Acknowledges FDA Form 483

A series of cardiometabolic-related news items has been observed from Kailera, Ascletis Pharma, Laekna, Glooko, SK pharmteco, and Novo Nordisk. Below, FENIX provides highlights and insights into 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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Kailera Initiates H2H Study Vs. Semaglutide; Structure Initiates Ph1 Amylin Study; Rona Unveils Bivalent siRNA; Lilly Partners for Obesity Drug Discovery and Initiates Brenipatide Ph2 Bipolar Trial; Enveda Receives IND; ICER Obesity Report

A series of cardiometabolic-related news items has been observed from Kailera Therapeutics, Structure Therapeutics, Rona Therapeutics, Lilly, Enveda, and ICER. 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 FY 2026 Investor Call; Kailera Initiates Ph3 Obesity Program; Noom Biomarker Partnership; GLP-1RA Retinopathy Lawsuits

A series of cardiometabolic-related news items has been observed from Pfizer, Kailera Therapeutics, Noom, and the US Judicial Panel. 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.

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.

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.

Hengrui/Kailera Positive Topline Ph3 Obesity Results in China; Currax Partners with GoodRx for Contrave Cash-pay Program 

Two cardiometabolic-related news items have been observed: Hengrui Pharma and Kailera Therapeutics announced topline data from Hengrui’s Ph3 obesity study of its SC GLP-1/GIP dual agonist in China (view press release; view CT.gov record); and Currax Pharmaceuticals has partnered with GoodRx for cash-pay Contrave (view press release). Below, FENIX provides highlights and insights into the respective 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.

Eversense 365 Launched in US; Kailera Launches as Obesity Biotech; Lilly Funds New $4.5B Indiana Facility

Three cardiometabolic-related news items have been observed: Ascensia Diabetes Care announced the launch of the Eversense 365 CGM in the US (view press release); Kailera Therapeutics announced its launch as a biotech with an asset in Ph3 development for the treatment of obesity (view press release; view article); and Lilly announced a $4.5B investment to create a new R&D and manufacturing facility in Lebanon, Indiana (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.