On the third day of ADA 2023, two cardiometabolic-related news items were observed. Below, FENIX provides context and analysis for the announcements.
Medtronic hosted its ADA 2023 investor event (view slides) and provided updates to the company’s diabetes business. Of note, commentary from Medtronic senior management indicates the Simplera CGM will not achieve an iCGM designation. Additionally, it should be noted that Medtronic’s CEO, Geoff Martha, participated in the ADA investor event, which hasn’t been the case in recent memory. Below, FENIX provides an overview of the Medtronic 2023 ADA investor event, including thoughts on Medtronic’s continued inability to achieve iCGM designation.
On the second day of ADA 2023, ten cardiometabolic-related news items were observed from Lilly, Zealand, BI, Novo Nordisk, Biomea Fusion, Sciwind Biosciences, Medtronic, Vertex, and Esperion. Below, FENIX provides context and analysis for the announcements.
In conjunction with the start of ADA 2023, Dexcom hosted its 2023 Investor Day (view slides) and provided updates across its business. Importantly, Dexcom disclosed plans to launch a CGM for people not on insulin in 2024 leveraging the G7 platform (view press release). Additionally, the company discussed the CGM opportunity in weight loss, pricing vs. Abbott Libre, updates to its 2025 long-range plan, and more (view press release). Below, FENIX provides highlights and insights from the Dexcom 2023 Investor Day, including thoughts on how the GLP-1RA weight loss hype has the potential to fuel CGM growth.
On the first day of ADA 2023, two cardiometabolic-related news items were observed from BI/Lilly and Intercept. Below, FENIX provides context and analysis for the announcements.
A series of cardiometabolic-related news items have been observed from EMA, Madrigal, Abbott, Bayer, Bigfoot, and Mannkind. Below, FENIX provides highlights and insights in the respective news items.
Intercept Pharmaceuticals announced it received a CRL from FDA regarding the obeticholic acid (OCA) NDA for the treatment of pre-cirrhotic liver fibrosis due to NASH. According to the press release, FDA indicated in the CRL that any resubmission of an NDA for OCA in NASH would require, at minimum, successful completion of the long-term outcomes phase of the REGENERATE study (view CT.gov record). As a result of the CRL, Intercept has decided to discontinue all NASH-related investment and restructure the company’s operations to strengthen its focus on rare and serious liver diseases. Below, FENIX provides brief thoughts on the CRL and Intercept’s decision.
Four cardiometabolic-related news items have been observed: Novo Nordisk announced it is taking legal actions over third-party semaglutide promotion (view press release); Versanis Bio announced it completed enrollment for the global Ph2b BELIEVE study evaluating the safety and efficacy of bimagrumab as a monotherapy and in combination with semaglutide in participants with obesity (view CT.gov record); FDA approved Jardiance and Synjardy to improve glycemic control in children 10 years of age and older with T2DM (view press release) as well as Agepha Pharma’s Lodoco in adult patients with established ASCVD or with multiple risk factors for cardiovascular disease (view press release). Below, FENIX provides highlights and insights into the respective news items, including brief thoughts on the bimagrumab + semaglutide program.
Three cardiometabolic-related news have been observed: the CHMP agenda (view here) for this month’s meeting (June 19-22) has been released, including Jardiance’s EMPA-KIDNEY and Mounjaro obesity indication extensions; AstraZeneca announced it is discontinuing development of its oral, AZD0186 (view article); and Lilly announced a partnership with ADA and Adam Duvall to increase awareness of Lilly’s insulin affordability programs (view press release). Below, FENIX provides context and insight on the respective news items, including insight into how Novo’s OASIS 1 readout likely influenced AZ’s decision.
Two cardiometabolic-related news items have been observed: Verve Therapeutics announced a partnership with Lilly to advance Verve’s gene editing program targeting Lp(a) for the treatment of ASCVD, ischemic stroke, thrombosis, and aortic stenosis (view press release); and Zucara Therapeutics announced it received $2M in funding from JDRF for its ZONE study, a Ph2 trial evaluating ZT-01 to reduce nocturnal hypoglycemia events in T1DM patients (view press release). Below, FENIX provides context and insight on the respective news items, including brief thoughts on the Verve partnership.