Category Archives: Topics

Insulet Hires New CEO; Galmed Sublingual Semaglutide; Vutrisiran ATTR-CM CHMP Opinion 

Three cardiometabolic-related news items have been observed: Ashley McEvoy has been appointed as Insulet’s new CEO (view press release); Galmed announced an agreement with Entomus for sublingual semaglutide development (view press release); and CHMP adopted a positive opinion for the vutrisiran ATTR-CM indication (view press release). Below, FENIX provides highlights and insights for the respective news items.

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AbbVie Q1 ‘25 Earnings; Madrigal Hires Ex-Novartis CVRM Development Lead

Two cardiometabolic-related news items have been observed: AbbVie hosted its Q1 ’25 earnings call (press release); and Madrigal Pharmaceuticals appointed former Novartis drug development lead, David Soergel, as its new CMO (press release). Below, FENIX provides highlights and insights for the respective news items.

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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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Lilly Ph3 Orforglipron T2DM Topline Results

Lilly announced topline results from its first Ph3 pivotal orforglipron (oral QD GLP-1RA) trial (ACHIEVE-1; view CT.gov record) demonstrating -1.5% reduction in A1C and -7.9% weight loss at the highest dose (36mg) at Week 40. For context, ACHIEVE-1 (n=559) evaluated the safety and efficacy of orforglipron vs placebo in adults with T2DM and inadequate glycemic control with diet and exercise alone. Lilly’s stock increased ~15% following the announcement. Below, FENIX provides highlights and insights from the ACHIEVE-1 trial, including readthrough to other obesity assets in development.

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Abbott Q1 ’25 Earnings Update 

Abbott hosted its Q1’25 earnings call (press release; infographic). Of note, there was minimal discussion of Abbott’s CGM business in prepared remarks and no questions from analysts during Q&A. Abbott’s CEO Rob Ford specifically stated, “I found it interesting we did not get a single Libre question, so you guys are very concerned on tariffs and macro…” Below, FENIX provides brief highlights and insights from the call.

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