A series of cardiometabolic-related news items has been observed from Novo Nordisk, Kailera, and Ionis Pharmaceuticals. Below, FENIX provides highlights and insights for the respective news items.
Novo Nordisk hosted its Q3 ’25 earnings call (press release; slides) and provided updates across its CVRM portfolio and obesity pipeline. Of note, the company has lowered its FY 2025 sales growth guidance again from 8-14% to 8-11% due to continued underperformance of its semaglutide franchise. Recall, at the beginning of the year, Novo originally guided that FY 2025 sales growth would be in the range of 16-24% (view slide). Below, FENIX provides highlights and insights from the Q3 ’25 earnings call, including thoughts on the Metsera acquisition saga.
Three cardiometabolic-related news items have been observed: Novo Nordisk resubmitted the Awiqli (insulin icodec) BLA but only for adults with T2DM (view press release); Boehringer Ingelheim (view press release) and Novartis (view press release) separately announced creation of DTP platforms; and Tandem Diabetes Care announced t:slim X2 with Control-IQ+ is now compatible with Lilly’s Lyumjev (view press release). Below, FENIX provides highlights and insights for the respective news items.
Novo Nordisk hosted a fireside chat with Martin Holst Lange at the EASD 2025 conference and provided updates to its pipeline and strategy. Below, FENIX provides highlights and insights from the call.
Two cardiometabolic-related news items have been observed: Lilly has stockpiled $548M worth of orforglipron in a risky move ahead of the regulatory filing/approval (view 10-K); and the CHMP agenda (view here) for this month’s meeting (Feb 24-27) has been released. Below, FEINX provides highlights and insights for the respective news items.
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.
Novo Nordisk hosted its Q3 ’24 earnings call (press release; slides) and provided updates across its CVRM portfolio, including new semaglutide PAD data. FENIX will cover Novo’s London Q3 ’24 earnings call tomorrow, November 7, 2024. Below, FENIX provides highlights and insights from the Q3 ’24 earnings call.
Two cardiometabolic-related news items have been observed: Lilly hosted its Q2 ’24 earnings call (press release; slides) and raised its FY2024 revenue guidance by $3.0B; and Novo Nordisk hosted its post-Q2 ’24 earnings London analyst event (view webcast). Below, FENIX provides highlights and insights for the respective calls.
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.
Novo Nordisk announced FDA issued a CRL regarding the QW insulin icodec BLA for the treatment of diabetes. According to the press release, the CRL outlines requests related to the manufacturing process and the T1DM indication. Novo stated it is evaluating the content of the CRL and will work closely with FDA to fulfill the requests. Of note, Novo does not expect to be able to fulfill the requests during 2024. Below, FENIX provides brief thoughts on the CRL in the context of the recent negative FDA adcom vote.