Tag Archives: Lilly

Akero Wins with Ph2b HARMONY MASH Results; Lilly Initiates Ph3 Lp(a) CVOT; vTv Submits T1DM Study Protocol to FDA

Three cardiometabolic-related news items have been observed: Akero announced 96-week HARMONY results evaluating efruxifermin (EFX) in MASH participants with stage 2 or 3 fibrosis (view press release); Lilly initiated the first trial in its Ph3 lepodisiran Lp(a) pivotal program (ACCLAIM-Lp(a); view CT.gov record); and vTv Therapeutics announced the submission of its cadisegliatin (TTP399) Ph3 T1DM protocol to FDA (view press release). Below, FENIX provides highlights and insights for the respective news items.

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Lilly Initiates Retatrutide T2DM Pivotal Program; Medtronic CY Q4 ’23 (FY Q3 ’24) Earnings; February CHMP Agenda; Inventiva Pauses Ph3 MASH Trial; Better Therapeutics Receives BDD for MASH

A series of cardiometabolic-related news items have been observed from Lilly, Medtronic, EMA, Inventiva, and Better Therapeutics. Below, FENIX provides highlights and insights for the respective news items, including thoughts on Lilly’s Ph3 T2DM pivotal program for retatrutide.

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Glyscend Initiates Ph2 GLY-200 Obesity Trial; BioAge Raises $170M Series D; Brenzavvy Mark Cuban Cost Plus Drug Company Update

Three cardiometabolic-related news items have been observed: Glyscend Therapeutics initiated a Ph2 trial evaluating its oral BID GLY-200 in obesity (view CT.gov record); BioAge announced the completion of its Series D financing round at $170M led by Sofinnova Investments and participation from Lilly Ventures and Amgen Ventures (view press release); TheracosBio announced it is extending its collaboration with the Mark Cuban Cost Plus Drug Company for Brenzavvy (view press release). Below, FENIX provides highlights and insights into the respective news items. 

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Mounjaro and Zepbound Launch Updates; Tirzepatide Ph2 MASH Data; Lilly’s Smart Insulin Enters Ph1; Lilly Q4 ’23 Earnings Update

Lilly hosted its Q4 ’23 earnings call (press release; slides) and provided updates across its CVRM portfolio. Of note, the company announced topline tirzepatide Ph2 SYNERGY-NASH data, discussed Zepbound launch updates, provided insight into manufacturing capacity increases, and disclosed its glucose-responsive insulin has entered clinical development, among other pipeline updates. Below, FENIX provides highlights and insights from the call.

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New Insulin Patch Pump; Pfizer Q4 ‘23 Earnings; Lilly Initiates Ph2 LA Amylin Obesity Trial; Lilly Trying to Get Mounjaro Reimbursed in Germany

A series of cardiometabolic-related news items have been observed from Modular Medical, Pfizer, and Lilly. Below, FENIX provides highlights and insights for the respective news items, including thoughts on why the new patch pump from Modular Medical may be an acquisition/partnership target by Medtronic.

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Dexcom to Build EU Manufacturing Plant; FDA Finds Manufacturing Lapses at Lilly Plant

Two cardiometabolic-related news items have been observed: Dexcom announced its first manufacturing facility in the EU for CGM sensors (view press release); and FDA has reportedly uncovered new manufacturing problems at a Lilly plant (view article). Below, FENIX provides highlights and insights for the respective news items.

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Lilly to Launch Mounjaro in EU; FDA Posts Libre 3 Android App Recall; Novo Initiates Ph1 Cagrisema Study in Weight Loss Mechanisms

Three cardiometabolic-related news items have been observed: Lilly has reportedly planned additional Mounjaro launches in 2024 once it receives EU approval for its pen injector (view article); FDA posted a Class 2 device recall for the Libre 3 Android App which was resolved in February 2023 (view recall); and Novo initiated a Ph1 cagrisema study (view CT.gov record). Below, FENIX provides highlights and insights for the respective news items.

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JPM 2024 Day 2: ABT, PODD, NVO, LLY, AZN, BAY, BMF, TDOC; Embecta Files 510(k) for T2DM Patch Pump; Omada Partners with Amazon for Cardiometabolic Programs

On the second day of JPM 2024, FENIX has provided coverage of presentations by major CVRM companies, including Abbott, Insulet, Novo Nordisk, Lilly, AZ, Bayer, Biomea, and Teladoc. GSK and Sanofi also presented at JPM 2024 but had no meaningful discussion relating to their respective CVRM portfolios. Separately, two CVRM-related news items have been observed: Embecta announced it submitted a 510(k) filing to FDA for its open-loop patch pump for T2DM (view press release); and Omada Health announced a partnership with Amazon’s Health Condition Programs for its cardiometabolic programs (view press release).

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