Tag Archives: Lilly

Full FLOW Results at ERA; Lilly Increases Manufacturing Investment to $9B

Two cardiometabolic-related news items have been observed: the full FLOW results were presented at ERA 2024 and simultaneously published in the NEJM (press release); and Lilly announced it increased its manufacturing investment for tirzepatide API production (press release). Below, FENIX provides highlights and insights for the respective news items.

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Lilly Ph3 QW Insulin Results; Roche Ph1 GLP-1/GIP RA Obesity Results; Zealand Q1 ’24 Earnings

Three cardiometabolic-related news items have been observed: Lilly announced QWINT-2 and QWINT-4 topline results, the first from its Ph3 QW insulin program (press release); Roche announced positive Ph1 CT-388 (GLP-1/GIP RA) obesity results (press release); and Zealand hosted its Q1 ’24 earnings call (press release). Below, FENIX provides highlights and insights for the respective news items, including thoughts on Lilly’s QW insulin program in the context of the impending Novo Nordisk QW icodec adcom on May 24, 2024.

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Lilly Partners for Cardiometabolic Drug Discovery; Insulet, 89bio, Arrowhead, and Akero Q1 ’24 Earnings; Medtronic Partners with Arecor for Implantable Pump; Senseonics Partners for Remote Care Platform; Noom Launches Movement Program for People on GLP-1RAs

A series of cardiometabolic-related news items have been observed from Lilly, Insulet, Arecor/Medtronic, Senseonics/Rimidi, 89bio, Arrowhead, Akero, and Noom. Below, FENIX provides highlights and insights for the respective news items.

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Lilly Raises 2024 Guidance on Strong Mounjaro/Zepbound Performance; Lilly Q1 ’24 Earnings Update

Lilly hosted its Q1 ’24 earnings call (press release; slides) and provided updates across its CVRM portfolio. Of note, Lilly raised its FY revenue guidance by $2.0B to $42.4B – $43.6B, primarily due to the strong performance of Mounjaro and Zepbound. Below, FENIX provides highlights and insights from the call, including thoughts on Lilly’s strategy to develop oral formulations for tirzepatide and retatrutide.

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Lilly Initiates Retatrutide CV and Renal Outcomes Study; Novo Initiates New Ph3 Cagrisema Maintenance Dose Study; US Senate Investigates Ozempic/Wegovy Pricing; Teladoc Q1 ’24 Earnings; Vance Swanson Joins Beta Bionics

A series of cardiometabolic-related news items have been observed from Lilly, Novo Nordisk, US Senate HELP Committee, Teladoc, and Beta Bionics. Below, FENIX provides highlights and insights for the respective news items.

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Icodec FDA Adcom Scheduled for May 2024

FDA has requested an adcom meeting on May 24, 2024, to discuss Novo Nordisk’s QW insulin icodec (view unpublished FDA document here). Recall, Novo previously disclosed FDA extended the icodec regulatory review by three months, with a decision now anticipated in Q3 2024 (previous FENIX insight). Below, FENIX provides insight on the potential implications and reasoning for an icodec adcom, including readthrough to Lilly’s QW insulin, efistora alfa.

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SELECT up for CHMP Opinion?; April CHMP Agenda; BI Partners for MASH; Lilly Acquires Nexus Manufacturing Site

Three cardiometabolic-related news items have been observed: The CHMP agenda for this month’s meeting (April 22-25) has been released and SELECT is likely up for an opinion (view CHMP agenda); Ochre announced it entered into a partnership with BI for liver disease (view press release); and Lilly announced an agreement to acquire an injectables manufacturing facility from Nexus Pharmaceuticals (view press release). Below, FENIX provides highlights and insights into the respective news items.

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Metsera Launches as Obesity Company; Lilly Initiates Ph2 Tizepatide+Mibavademab Obesity Trial; Skye Uplists to Nasdaq Global Market

Three cardiometabolic-related news items have been observed: Metsera announced its launch as an obesity company (view press release); Lilly initiated a Ph2 trial evaluating tirzepatide + mibavademab vs. tirzepatide monotherapy in obesity (view CT.gov record); and Skye Biosciences announced it received approval to list its common stock on the Nasdaq Global market stock exchange (view press release). Below, FENIX provides highlights and insights for the respective news items, including thoughts on the potential new obesity partnership between Lilly and Regeneron.

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