Tag Archives: HRS9531

JPM 2026 Day 4: IVA, JNGHF, LXRX, BMEA, ESPR; FDA Delays CNPV Approvals

On the fourth and final day of JPM 2026, FENIX has provided coverage of presentations by Inventiva Pharma, Jiangsu Hengrui Pharmaceuticals, Lexicon Pharmaceuticals, Biomea Fusion, and Esperion. Separately, one CVRM-related news item has been observed: FDA has delayed CNPV approval of Tzield and orforglipron (view article). Below, FENIX provides highlights and insights from the JPM presentations as well as insight into the CNPV delays.

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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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ESC 2025: Novo, Roche/Alnylam, and AstraZeneca Present New Data; Medtronic Closes in on Abbott CGM Launch; Ionis Topline Ph3 Olezarsen Results; NMPA Accepts Hengrui’s Obesity Application; Ypsomed’s SmartPilot Receives 510(k) Clearance; Biophytis Ph2 BIO101 Obesity Study; Skye Completes Ph2 Nimacimab Dosing 

A series of cardiometabolic-related news items has been observed from Novo Nordisk, Medtronic, Roche/Alnylam, AstraZeneca, Ionis Pharmaceuticals, Jiangsu Hengrui, Ypsomed, Biophytis, and Skye Bioscience. Below, FENIX provides highlights and insights for the respective news items.

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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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JPM 2025 Day 1: DXCM, AMGN, VKTX, PFE, ZEAL, MDT, REGN, VTX, ALNY, CYTK; Metsera Files for IPO; Fractyl REVEAL-1 Data; Ro Zepbound DTC; 89bio 2025 Outlook

On the first day of JPM 2025, FENIX has provided coverage of presentations by major CVRM companies, including Dexcom, Amgen, Viking, Pfizer, Zealand, Medtronic, Regeneron, Vertex, Alnylam, and Cytokinetics. Roche also presented at JPM 2025 but had no meaningful discussion relating to its CVRM portfolio. Additionally, a series of CVRM-related news items have been observed:

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