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.

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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.

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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.

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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.

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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.

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