A series of cardiometabolic-related news items has been observed from AstraZeneca, EMA, Regeneron, Lilly, and Novo Nordisk. Below, FENIX provides highlights and insights for the respective news items.
Four cardiometabolic-related news items have been observed from Altimmune, Sagimet Biosciences, Ascletis Pharma, and Fauna Bio. Below, FENIX provides highlights and insights for the respective news items.
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.
Earlier this week, FDA approved Farxiga (dapagliflozin) to reduce the risk of CV death, hospitalization for HF, and urgent HF visit in adults with HF, regardless of baseline LVEF (view updated Farxiga label; previous FENIX insight). The label extension was based on positive results from the Ph3 DELIVER trial (view CT.gov record). Recall, in February 2023, Forxiga received EU approval for the expanded HF indication (previous FENIX insight). Below, FENIX has conducted a Farxiga HF label analysis in the context of the Jardiance HF indication.
Lilly has recently initiated the Ph3 tirzepatide HFpEF trial, called SUMMIT (view CT.gov record). Recall, during Lilly’s 2021 guidance call (December 15, 2020), Lilly first disclosed plans to develop tirzepatide for the treatment of HFpEF (previous FENIX insight). Below, FENIX provides an overview of SUMMIT, including a comparative analysis with Novo’s semaglutide HFpEF trial (STEP HFpEF).
Last week, Novartis received FDA approval for expanding the Entresto label in HF beyond HFrEF (previous FENIX insight). Ahead of Lexicon’s Q4 2020 earnings later in March, FENIX provides a reminder on the recent sequence of events in HF and thoughts on how the new HF labeling for Entresto could apply to Lexicon’s SGLTi, sotagliflozin.