Category Archives: Topics

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FDA has requested an adcom meeting on May 24, 2024, to discuss Novo Nordisk’s QW insulin icodec (view unpublished FDA document here).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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Dexcom Q1 ’24 Earnings

Dexcom hosted its Q1 ’24 earnings call (press release; slides) and provided updates across its business. Unsurprisingly, much of the prepared remarks and Q&A portions of the call were dedicated to Stelo and the impending launch in Summer 2024. Below, FENIX provides highlights and insights from the call.

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Study on Eligible Wegovy Patients through Medicare; Roche Q1 ’24 Earnings

Two cardiometabolic-related news items have been observed: a recent study from Kaiser showed that approximately 3.6M overweight or obese patients with heart conditions insured under Medicare could be eligible for Wegovy (view article); and Roche hosted its Q1 ’24 earnings call (press release; slides). Below, FENIX provides highlights and insights for the respective news items.

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Novartis Q1 ’24 Earnings; Vertex Partners with TreeFrog for T1DM Manufacturing

Two cardiometabolic-related news items have been observed: Novartis hosted its Q1 ’24 earnings call (press release; slides); and Vertex announced an exclusive licensing agreement with TreeFrog Therapeutics for TreeFrog’s proprietary cell manufacturing technology (view press release). Below, FENIX provides highlights and insights for the respective news items.

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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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