Tag Archives: tirzepatide

Sernova Announces Conformal Coating Technology Advancements; Lilly and BioAge to Initiate Ph2 Tirzepatide Combo Trial; Lilly Partners with Redwire for Cardiometabolic Space Research; EMA Finds No Link Between GLP-1RAs and Thyroid Cancers; Sanofi Invests in MeiraGTx for Gene Regulation Technology

A series of cardiometabolic-related news items have been observed from Sernova, Lilly/BioAge, Lilly/Redwire, EMA, and Sanofi. Below, FENIX provides highlights and insights into the respective news items.

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SURMOUNT-3 Presented at ObesityWeek; Novo Adds to Its CKD Pipeline; Carmot Presents T2DM/Obesity Results; Better Therapeutics Launches AspyreRx for T2DM

Four cardiometabolic-related news items have been observed: Lilly announced detailed results from SURMOUNT-3, in which tirzepatide demonstrated an additional -21.1% weight loss after 12 weeks of intensive lifestyle management (view press release); Novo Nordisk announced it will acquire an MRA asset from KBP Biosciences for $1.3B (view press release); Carmot Therapeutics presented data from its T2DM/obesity pipeline at the 2023 ObesityWeek conference (view press release); and Better Therapeutics initiated the AspyreRx launch for T2DM (view press release). Below, FENIX provides highlights and insights into the respective news items.

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Lilly Initiates Tirzepatide Obesity Trial in Adolescents; Survodutide CVOT Observed; FDA Creates New Digital Health Advisory Committee; Better Therapeutics Announces AspyreRx Subgroup Topline Results; Virta Partners with Navitus for T2DM and Obesity

Five cardiometabolic-related news items have been observed: Lilly initiated a Ph3 study evaluating tirzepatide vs. placebo in adolescents who have obesity or are overweight with weight-related comorbidities (SURMOUNT-ADOLESCENTS; view CT.gov record); BI’s SYNCHRONIZE-CVOT, evaluating survodutide in people with overweight or obesity with CVD, CKD, or at least two risk factors for CVD was observed on CT.gov (view CT.gov record); FDA announced the creation of a new Digital Health Advisory Committee (view press release); Better Therapeutics announced topline results from a subgroup analysis of AspyreRx in T2DM (view press release); and Navitus Health Solutions announced a partnership with Virta Health to make Virta’s T2DM health solutions available to Navitus clients (view press release). Below, FENIX provides highlights and insights into the respective news items.

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FDA Approves Jardiance for Adults with CKD; Abbott Completes Bigfoot Acquisition; Insulet Publishes “Market Opportunity & Impact of GLP-1s” Presentation; Lilly initiates Ph3 H2H Orforglipron vs. Semaglutide and New Ph3b Tirzepatide Max Dose Study in Obesity

A series of cardiometabolic-related news items have been observed from BI/Lilly, Abbott, Insulet, and Lilly. Below, FENIX provides highlights and insights into the respective news items.

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Ypsomed Signs Long-Term Autoinjector Supply Deal with Novo; Lilly Files Lawsuits Over Copycat Mounjaro Products

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.

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Lilly Initiates New Ph2 Study Investigating High Doses of Tirzepatide in Patients with T2DM and Obesity; Gan & Lee Doses First Patient in Ph2 QW Insulin Study; BMS discontinues NASH asset

Three cardiometabolic-related news items have been observed: Lilly initiated a Ph2 study to investigate high doses of tirzepatide in patients with T2DM and obesity that are on metformin (view CT.gov record); Gan & Lee announced the first subject has been dosed in its Ph2 study evaluating QW insulin, GZR4, in 130 Chinese adult subjects with T2DM (view press release); and BMS disclosed it is terminating its program evaluating HSP47 in NASH during its R&D day (view article). Below, FENIX provides highlights and insights into the respective news items.

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Lilly Up Big Following Q2 ’23 Results and SELECT Data Readout

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.

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Lilly Completes Tirzepatide Obesity Trials; Teladoc, Viking, and Roche Q2 ‘23 Earnings

Four cardiometabolic-related news items have been observed: Lilly announced topline results from SURMOUNT-3 and SURMOUNT-4, demonstrating up to 26.6% mean weight loss (view press release); Teladoc Health (press release; slides), Viking Therapeutics (press release), and Roche (press release; slides) hosted their respective Q2 ‘23 earnings calls. Below, FENIX provides highlights and insights into the respective news items.

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ADA 2023 Key Press Releases (June 24)

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.

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