Tag Archives: CHMP

Novo’s Wegovy Pill Receives Approval in EU; Gubra Initiates FIH Study for Muscle-Sparing Asset; GSK Initiates Ph3 Efimosfermin Studies in MASH; Fractyl One Year Data; Ascletis Selects Another FDC in Obesity; Rani Topline Ph1 Data; BI H1 2026 Updates

A series of cardiometabolic-related news items has been observed from Novo Nordisk, Gubra, GSK, Fractyl Health, Ascletis Pharma, Rani Therapeutics, and Boehringer Ingelheim. Below, FENIX provides highlights and insights for the respective news items.

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June CHMP Meeting Highlights; New Enicepatide China-Based Ph3 Obesity Study; Cirius Initiates Ph2 Dosing in T1DM Study

Three cardiometabolic-related news items have been observed: The CHMP highlights for this month’s meeting (June 22-25) have been released (view highlights), Roche initiated a new Ph3 China-based enicepatide obesity study (view CT.gov record), and Cirius Therapeutics initiated enrollment and dosing in its Ph2 T1DM study (view CT.gov record). Below, FENIX provides highlights and insights for the respective news items.

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New Foundayo DTC Ad; Roche Shares New INN for CT-388; April CHMP Agenda

Three cardiometabolic-related news items have been observed: Lilly aired a new Foundayo DTC ad on social media platforms (view Reddit post); Roche’s CT-388 has been given the INN of enicepatide, which is reflected in two Ph2 studies (view CT.gov record; view CT.gov record); and the CHMP agenda for this month’s meeting (April 20-23) has been released (view here). Below, FENIX provides highlights and insights on the respective news items.

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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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