Category Archives: Uncategorized

Tandem Mobi Receives FDA Clearance; Better Therapeutics’s AspyreRx Receives FDA Authorization for T2DM

Two cardiometabolic-related news items have been observed: Tandem announced FDA clearance of the Tandem Mobi insulin pump for PWD ≥6 years of age (view press release); and Better Therapeutics announced FDA authorized AspyreRx to provide cognitive behavioral therapy for adults with T2DM and held an associated investor call (view press release; webcast). Below, FENIX provides highlights and insights into the respective news items.

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Medtronic CY Q1 ‘23 (FY Q4 ‘23) earnings update

Medtronic hosted its CY Q1 ‘23 (FY Q4 ‘23) earnings call (press release; slides) and provided brief updates to its diabetes business. Importantly, Medtronic disclosed plans to acquire EOFlow Co. Ltd. for its patch pump technology (view press release). Additionally, Medtronic will be hosting an investor event at ADA 2023 where it will provide more details on its diabetes portfolio and pipeline. Below, FENIX provides highlights and insights from the earnings call, including thoughts on how the EOFlow acquisition fits into Medtronic’s strategy to turn around its struggling diabetes business.

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Structure Therapeutics Advances Oral GLP-1RA to Ph2; Embecta and Tidepool Partner for T2DM Patch Pump AID Development; New SOLOIST-WHF Analysis

Three cardiometabolic-related news items have been observed: Structure Therapeutics announced it is advancing its oral GLP-1RA (GSBR-1290) into Ph2a development for T2DM and obesity (view press release); Embecta announced it has partnered with Tidepool to develop an AID system for its T2DM patch pump (view press release); and Lexicon announced results from an investigator-initiated analysis of SOLOIST-WHF which demonstrated that sotagliflozin is cost-effective at commonly accepted willingness-to-pay thresholds in patients with diabetes and worsening HF (view press release). Below, FENIX provides highlights and insights into the respective news items.

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Intercept, AZ, and Sanofi Q1 ’23 Earnings; Sanofi Completes Provention Acquisition; DRI Sells Tzield Royalties to Sanofi

Five cardiometabolic-related news items have been observed: Intercept (press release; slides), AstraZeneca (press release; slides), and Sanofi (press release; slides) hosted their respective Q1 ’23 earnings calls; Sanofi announced it has completed its acquisition of Provention Bio (view press release); and DRI Healthcare Trust announced that it has sold its Tzield royalty interests and milestone payment obligations to Sanofi for $210M (view press release). Below, FENIX provides highlights and insights from the call.

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Novartis Q1 ’23 Earnings; Insulet Basal-Only T2DM Pod Receives FDA Clearance; Vadadustat Approved by EC; Sernova Announces Positive T1DM Preclinical Data with Evotec’s iPSC-Derived ILCs

Four cardiometabolic-related news items have been observed: Novartis hosted its Q1 ’23 earnings call (press release; slides); Insulet announced its basal-only T2DM pod, Omnipod GO, received FDA clearance for use in T2DM patients 18 years of age or older (view press release); Akebia Therapeutics announced the European Commission granted marketing authorization for Vafseo (vadadustat) for the treatment of symptomatic anemia associated with CKD in adults on chronic maintenance dialysis (view press release); and Sernova announced positive T1DM preclinical data for its implantable Cell Pouch device in combination with Evotec’s iPSC-derived islet-like clusters (view press release). Below, FENIX provides highlights and insight into the respective news items.

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New Tirzepatide Injection Device Trial; Novo Partners with Aspect Biosystems; Sanofi’s Provention Bio Acquisition Regulatory Issue; Glooko Partners with Hedia

Four cardiometabolic-related news items have been observed: Lilly initiated a Ph1 tirzepatide trial evaluating a new injection device (view CT.gov record); Novo Nordisk and Aspect Biosystems announced a collaboration, development, and license agreement to develop bioprinted tissue therapeutics for diabetes and obesity (view press release); Sanofi announced it has withdrawn and refiled its Premerger Notification and Report Form under the Hart-Scott-Rodino Act of 1976 (HSR Act) for its pending acquisition of Provention Bio (view press release); and Glooko announced a new global partnership with Hedia (view press release). Below, FENIX provides highlights and insights into the respective news items including thoughts on Lilly’s potential new injection device. 

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Akero to Initiate Ph3 NASH Program; Bigfoot Acquires Insulin Titration Algorithm; GSK Collaborates with PathAI in NASH

Three cardiometabolic-related news items have been observed: Akero Therapeutics announced it had a positive end-of-Ph2 meeting with FDA and disclosed details of the anticipated SYNCHRONY Ph3 efruxifermin (EFX) program for the treatment of NASH (view press release); Bigfoot Biomedical has acquired an insulin titration algorithm developed at McGill University (view press release); and PathAI announced it is partnering with GSK on the Ph2b HORIZON NASH trial (view CT.gov record; press release). Below, FENIX provides highlights and insights into the respective news items including thoughts on the competitive NASH therapies in development.

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Mounjaro Obesity Indication Filed in EU; March CHMP Agenda; Vertex Announces T1DM Licensing Agreement with CRISPR; Sanofi Helps Dario Secure Top-Ten PBM Contract

Three cardio-metabolic related news items have been observed: The CHMP agenda (view here) for this month’s meeting (March 27-30) has been released, which includes the new filing of the Mounjaro non-T2DM obesity indication; Vertex announced it has entered into a new non-exclusive licensing agreement with CRISPR Therapeutics for the use of CRISPR’s gene editing technology (view press release); and DarioHealth announced a new contract with an undisclosed top-ten PBM to provide Dario digital therapeutics beginning in Q2 2023 (view press release). Below, FENIX provides highlights and insights from the respective news items, including potential readthrough to the US Mounjaro obesity regulatory strategy.

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Teladoc, Alnylam, and Amarin Q3 ’22 Earnings Updates

A series of cardiometabolic-related news items have been observed: Teladoc (press release; slides), Alnylam (press release; slides), and Amarin (press release; slides) hosted their Q3 ’22 earnings calls. Below, FENIX provides highlights and insights for the respective new items.

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