Tag Archives: EMA

Skye Partners for Obesity Development; May CHMP Agenda; Altimmune Initiates Ph2 Study in AUD; Zealand Appoints New CDO; Cytokinetics Presents Additional Aficamten Analyses; Ionis Ph3 Olezarsen Topline Data 

A series of cardiometabolic-related news items has been observed from Skye Bioscience, EMA, Altimmune, Zealand Pharma, Cytokinetics, and Ionis Pharmaceuticals. Below, FENIX provides highlights and insights for the respective news items.

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Akero Wins with F4 MASH Endpoint; Semaglutide + Enobosarm Combination Data; January 2025 CHMP Agenda

Three cardiometabolic-related news items have been observed: Akero Therapeutics announced positive topline results from its Ph2b SYMMETRY trial (view press release), Veru announced Ph2b semaglutide + enobosarm topline data (view press release); and the CHMP agenda for this month’s meeting (Jan 27-30) has been released (view here). Below, FENIX provides highlights and insights for the respective news items.

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December CHMP Agenda; Senseonics Eversense 365 Launch Updates; BioAge Discontinues Ph2 Obesity Trial

Three cardiometabolic-related news items have been observed: the CHMP agenda for this month’s meeting (Dec 9-12) has been released (view here); Senseonics announced commercial updates to its Eversense 365 launch (view press release); and BioAge announced the discontinuation of its Ph2 obesity trial (view press release). Below, FENIX provides highlights and insights for the respective news items.

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Insulet Q4 ’23 Earnings; SELECT CHMP Decision in April?; Silence Achieves $10M Milestone Payment from AZ

Three cardiometabolic-related news items have been observed: Insulet hosted its Q4 ’23 earnings call (press release; slides); EMA reportedly intends to issue a decision for the potential use of Wegovy in treating heart disease by April (view article); and Silence Therapeutics announced it achieved a $10M milestone payment followed by the initiation of a Ph1 trial by AstraZeneca (view press release). Below, FENIX provides highlights and insights for the respective news items.

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SURMOUNT-4 Results Published in JAMA; December CHMP Agenda; Fractyl Health Presents GLP-1RA PGTx Findings at WCIRDC 2023

Three cardiometabolic-related news items have been observed: Lilly announced detailed results from SURMOUNT-4 have been published in JAMA (view press release; view publication); the CHMP agenda (view here) for this month’s meeting (December 11-14) has been released; and Fractyl Health presented findings from its Rejuva GLP-1RA-based gene therapy candidate (GLP-1RA PGTx) vs. semaglutide at WCIRDC 2023 in Los Angeles, CA on December 7-9, 2023 (view press release). Below, FENIX provides highlights and insights into the respective news items.

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