FDA recently approved Lilly’s tirzepatide, branded as Zepbound, for the treatment of adults who are obese or overweight with weight-related comorbidities such as hypertension, T2DM, OSA, or CVD (view label; previous FENIX insight). Below, FENIX has conducted a Zepbound label, website, and pricing analysis, including thoughts on Lilly’s innovative targeting of employers.
A series of cardiometabolic-related news items have been observed from Lilly, Novo Nordisk, Madrigal, Akero, Boston Pharmaceuticals, and Smart Meter. Below, FENIX provides highlights and insights into the respective news items.
Lilly hosted its Q3 ’23 earnings call (press release; slides) and provided updates across its CVRM portfolio. Management noted the 2024 guidance call will be held in January which is new as the company traditionally hosted these calls in December of the preceding year. Below, FENIX provides highlights and insights from the call.
Two cardiometabolic-related news items have been observed: Lilly has reportedly hired CordenPharma to produce Mounjaro (view article); and Diamyd Medical announced preliminary results from DIAGNODE-B which provided additional support for the safety and feasibility of booster injections of Diamyd (view press release). Below, FENIX provides highlights and insights into the respective news items.
On the third day of EASD 2023, four key news items were observed from Lilly, Vertex, Phillips-Medisize, and Welldoc. The following topics are covered below (hyperlinks to external items):
Four cardiometabolic-related news items have been observed: Rockley Photonics announced it is continuing to make progress on non-invasive glucose sensing with its wearable silicon photonics-based sensor (view press release); Intercept announced it has entered a definitive agreement to be acquired by Alfasigma (view press release); EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) will reportedly be discussing aspiration-related risks associated with GLP-1RAs in its September 2023 meeting (view article); and Kallyope announced it initiated a Ph2 trial evaluating K-757 and K-833, oral nutrient receptor agonists, for the treatment of obesity and T2DM (view press release). Below, FENIX provides highlights and insights into the respective news items.
Two cardiometabolic-related news items have been observed: Ypsomed announced it has signed a long-term supply agreement with Novo Nordisk to manufacture autoinjectors for various metabolic drugs currently undergoing clinical trials (view press release); and Lilly has recently sued 10 medical spas, wellness centers, and compounding pharmacies for selling unapproved and compounded versions of tirzepatide (view article). Below, FENIX provides highlights and insights into the respective news items.
A final draft guidance from the UK’s NICE now recommends Mounjaro for T2DM (view article). According to the article, final guidance from NICE is scheduled to be published on Oct 11, 2023, and the drug will be made available in the UK’s National Health Service (NHS) within 90 days. Recall, in June 2023, NICE did not recommend Mounjaro as a treatment for T2DM and asked Lilly for more data (previous FENIX insight). Below, FENIX provides brief thoughts on the NICE recommendation.
Lilly hosted its Q2 ’23 earnings call (press release; slides) and provided updates across its CVRM portfolio. Of note, Mounjaro led Lilly’s new products category with WW Q2 ’23 sales reaching nearly $1B. Following the Q2 ’23 beat, increased FY 2023 guidance, and bolstered by Novo’s SELECT readout (previous FENIX insight), Lilly’s stock jumped +15% to an all-time high of ~$521/share. Unsurprisingly, Lilly also provided commentary surrounding the SELECT data readout. Below, FENIX provides highlights and insight from the call, including additional thoughts on the evolving obesity CVOT dynamic.
A series of cardiometabolic-related news items have been observed from Lilly, Vertex, Amarin, Intercept, Glenmark, Dario, and Tandem. Below, FENIX provides highlights and insights for the respective news items.