Tag Archives: CHMP

Novo Initiates Ph1 Oral ASCL5 Inhibitor Study for Obesity; FDA to Host Public Feedback Meeting on CNPV; March CHMP Agenda

Three cardiometabolic-related news items have been observed: Lexicon Pharmaceuticals and Novo Nordisk initiated a Ph1 obesity study of its oral ASCL5 inhibitor (view press release); FDA shared plans to host a public feedback meeting regarding the CNPV pilot program (view press release); and the CHMP agenda for this month’s meeting (March 23-26) has been released (view agenda). Below, FENIX provides highlights and insights for the respective news items.

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Structure Q4 ’25 Earnings; February CHMP Meeting Highlights

Two cardiometabolic-related news items have been observed: Structure released its Q4 ’25 earnings report (press release), and the CHMP highlights for this month’s meeting (February 23-26) have been released (view highlights). Below, FENIX provides highlights and insights for the respective news items.

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ADA 2025 Key Press Releases (June 20) 

On the first day of the ADA 2025 conference, seven cardiometabolic-related news items have been observed from Novo Nordisk, Tandem Diabetes Care, Beta Bionics, Ypsomed/CamDiab, Madrigal Pharmaceuticals, and Pfizer. Below, FENIX provides context and analysis for the announcements. 

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Insulet Hires New CEO; Galmed Sublingual Semaglutide; Vutrisiran ATTR-CM CHMP Opinion 

Three cardiometabolic-related news items have been observed: Ashley McEvoy has been appointed as Insulet’s new CEO (view press release); Galmed announced an agreement with Entomus for sublingual semaglutide development (view press release); and CHMP adopted a positive opinion for the vutrisiran ATTR-CM indication (view press release). 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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November CHMP Agenda

The CHMP agenda (view here) for this month’s meeting (Nov 11-14) has been released and includes several cardiometabolic-related agenda items. Below, FENIX provides highlights and insights for the agenda.

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Novo CB1 Ph2a Obesity Topline Results; Two Ph3 Tirzepatide Combo Psoriatic Studies Observed; Aligos Ph2a MASH Topline Results; AZ Initiates Ph2 LA Amylin Obesity Study; FTC Sues PBMs; Synjardy Receives Pediatric CHMP Positive Opinion

A series of cardiometabolic-related news items have been observed from Novo Nordisk, Lilly, Aligos Therapeutics, AstraZeneca, FTC, and CHMP. Below, FENIX provides highlights and insights for the respective news items.

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