Tag Archives: Medtronic

Viking’s Topline AE Data Scares the Street; Medtronic Q2 ‘25 Earnings; Novo Partners for Oral Peptide Research; Rezdiffra Gains EU Marketing Authorization; UK Approves Tzield; Luna Closes Series A Funding Round; Health Canada Approves FLOW; EMA Accepts NewAmsterdam’s Obicetrapib MAA 

A series of cardiometabolic-related news items has been observed from Viking Therapeutics, Medtronic, Novo Nordisk, Madrigal Pharmaceuticals, Sanofi, Luna Health, and NewAmsterdam Pharma. Below, FENIX provides highlights and insights for the respective news items.

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July CHMP Agenda; MiniMed 780G CE Mark for Expanded Indication; Dexcom Receiver Recall  

Three cardiometabolic-related news items have been observed: The CHMP agenda for this month’s meeting (July 21-24) has been released (view here); Medtronic announced its MiniMed 780G pump received CE Mark for ages 2+ years of age, T2DM, and during pregnancy (view press release); and FDA announced Dexcom’s CGM receivers have been recalled for faulty alert sounds (view press release). Below, FENIX provides highlights and insights for the respective news items, including thoughts on Novo’s EU semaglutide MASH regulatory strategy.

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ADA 2025 Key Press Releases (June 21)  

On the second day of the ADA 2025 conference, six cardiometabolic-related news items have been observed from Lilly, Novo Nordisk, Vertex Pharmaceuticals, Senseonics, Medtronic, and Corxel Pharmaceuticals. Below, FENIX provides context and analysis for the announcements.

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Novo Advances Amycretin to Ph3; Medtronic Diabetes Reclaims MiniMed Name; Vertex Layoffs After Failed T1DM Program 

Three cardiometabolic-related news items have been observed: Novo Nordisk advances amycretin into Ph3 development (view press release); Medtronic named its diabetes spinoff company “MiniMed” (view press release); and Vertex lays off employees due to its failed T1DM program (view article). Below, FENIX provides highlights and insights for the respective news items. 

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Medtronic to Spin Off Diabetes Business and CY Q1 ’25 (FY Q4 ’25) Earnings; Akero Acquisition Rumor 

Two cardiometabolic-related news items have been observed: Medtronic announced plans to spin off its diabetes business (press release; slides) and hosted its CY Q1 ’25 (FY Q4 ’25) earnings call (press release; slides); and Akero Therapeutics has reportedly received an acquisition proposal from an undisclosed strategic buyer (view article). Below, FENIX provides highlights and insights for the respective news items, including thoughts on what the Medtronic diabetes spinoff means for the rest of the market.

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Medtronic Receives FDA Approval for Simplera + MiniMed 780G

Medtronic announced FDA approval of the supplemental PMA for Medtronic’s Simplera Sync CGM sensor for use with the MiniMed 780G system. Recall, the standalone Simplera CGM was approved by FDA in August 2024 (previous FENIX insight). According to the press release, a limited US launch of the Simplera Sync sensor will begin in Fall 2025. Below, FENIX provides brief insight into the approval.

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