Category Archives: GLP-1RA + Basal

STEP HFpEF Withdrawn; QM GLP/GIP Withdrawn; Novo Q2 ’24 Earnings

Novo Nordisk hosted its Q2 ’24 earnings call (press release; slides) and provided updates across its CVRM portfolio. Importantly, Novo disclosed it has withdrawn the STEP HFpEF sNDA and it discontinued development of its QM GLP/GIP dual agonist, among other updates. FENIX will cover Novo’s London Q2 ’24 earnings call tomorrow, August 8, 2024. Below, FENIX provides highlights and insights from the Q2 ’24 earnings call.

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May CHMP Agenda; Noom and Ro GLP-1RA Ads Observed; NewAmsterdam Lp(a) Results

Three cardiometabolic-related news items have been observed: The CHMP agenda for this month’s meeting (May 27-31) has been released (view here); New Ro and Noom GLP-1RA ads have been observed; and NewAmsterdam announced obicetrapib (CETP inhibitor) results (view article). Below, FENIX provides highlights and insights for the respective news items.

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Icodec up for CHMP Opinion; March CHMP Agenda; Galmed Granted MASH Combo Patent; Sequel’s twiist AID Receives 510(k) Clearance

Three cardiometabolic-related news items have been observed: The CHMP agenda for this month’s meeting (March 18-21) has been released and Novo Nordisk’s insulin icodec is up for an opinion (view CHMP agenda); Galmed announced it was granted an EU patent for the combination of aramchol and resmetirom for the treatment of MASH and liver fibrosis (view press release); and Sequel Med Tech announced it received 510(k) clearance for the twiist AID system (view press release). Additionally, FENIX has provided a correction to Novo’s new Rybelsus doses based on information from its Q3 2023 earnings press release. Below, FENIX provides highlights and insights into the respective news items.

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Lilly Initiates Retatrutide T2DM Pivotal Program; Medtronic CY Q4 ’23 (FY Q3 ’24) Earnings; February CHMP Agenda; Inventiva Pauses Ph3 MASH Trial; Better Therapeutics Receives BDD for MASH

A series of cardiometabolic-related news items have been observed from Lilly, Medtronic, EMA, Inventiva, and Better Therapeutics. Below, FENIX provides highlights and insights for the respective news items, including thoughts on Lilly’s Ph3 T2DM pivotal program for retatrutide.

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