Tag Archives: tirzepatide

FDA Clears Abbott’s Lingo and Libre Rio CGMs; Lilly Publishes SYNERGY-NASH Results; Teladoc Appoints New CEO

Three cardiometabolic-related news have been observed: Abbott announced FDA cleared its Lingo and new “Libre Rio” CGM systems for OTC (view press release); Lilly announced detailed results from the Ph2 SYNERGY-NASH trial were presented at EASL 2024 (June 5-8; Milan, IT) and published in the NEJM (view press release); and Teladoc appointed Charles Divita, III, as its CEO effective immediately (view press release). Below, FENIX provides highlights and insights for the respective news items, including thoughts on how Lingo and Libre Rio will compete with Dexcom’s Stelo.

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NICE to Recommend Tirzepatide for Obesity; Lilly and Altimmune MASH Data at EASL 2024; Lilly Initiates Ph1 Orforglipron Capsule vs. Tablet Bridging Study; Dexcom G7 Direct to Apple Watch Now Available

A series of cardiometabolic-related news items have been observed from UK’s NICE, Lilly, Altimmune, and Dexcom. Below, FENIX provides highlights and insights for the respective news items.

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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 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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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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SURMOUNT-OSA Topline Results; Abbott Q1 ‘24 Earnings; Lilly Insulin Settlement Dropped; NeuroBo Doses First Patient in Ph1 Obesity Trial

Four cardiometabolic-related news items have been observed from Lilly, Abbott, and NeuroBo. Below, FENIX provides highlights and insights for the respective news items.

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Lilly Loses Counterfeit Tirzepatide Lawsuit; EMA Finds No Link Between GLP-1RAs and Suicide Ideation; Diamyd Ph3 Recruitment Update

Three cardiometabolic-related news items have been observed: Lilly loses counterfeit tirzepatide lawsuit (view article); EMA found no link between GLP-1RAs and suicide ideation (view meeting highlights); and Diamyd reached a recruitment milestone for its Ph3 DIAGNODE-3 trial in T1DM (view press release). Below, FENIX provides highlights and insights for the respective news items.

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ATTD 2024 Key Press Releases Day 1 (March 6)

On the first day of ATTD 2024, seven cardiometabolic-related news items were observed from Roche, Dexcom, Abbott, Lilly, Know Labs, Akero, and Biomea Fusion. Below, FENIX provides highlights and insights for the respective news items.

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Mounjaro KwikPen Approved in UK; Biocorp Receives 510(K) Clearance for SoloSmart; Novo Initiates Second Ph3 Cagrisema T2DM Trial; Mounjaro 12.5mg Added to FDA Shortage Database; Counterfeit Ozempic Causes Cases of Hypoglycemia

Five cardiometabolic-related news items have been observed from Lilly, Biocorp, and Novo Nordisk. Below, FENIX provides highlights and insights for the respective news items.

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Holiday Hangover: FDA Issues Dasiglucagon CRL for CHI; Cytokinetics Ph3 Aficamten Results; NeuroBo Submits Obesity IND; New O5 Algorithm Trial Observed; Tirzepatide in T1DM Trial; Novo Warns Against Counterfeit Ozempic in US; Glucotrack Preclinical Implantable CGM Data

During the holiday break, a series of cardiometabolic-related news items were observed from Zealand, Cytokinetics, NeuroBo, Insulet, Royal North Shore Hospital, Novo Nordisk, and Glucotrack. Below, FENIX provides highlights and insights for the respective news items.

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