Category Archives: Topics

Esperion Launches Website Featuring CLEAR Outcomes; Abbott Receives 510(k) Approval for APIs; Novartis Initiates Ph3 Inclisiran Primary Prevention Trial; Nemaura and Viatris Q4 ’22 Earnings Updates

Five cardiometabolic-related news items have been observed: Esperion announced it has launched a new website (esperionscience.com) featuring information about CLEAR Outcomes (view press release); Abbott received FDA 510(k) approval to add APIs to the FreeStyle Libre 2 and 3 CGM systems (view 510(k) decision letter); Novartis has initiated a Ph3 trial evaluating inclisiran vs. placebo in a primary prevention cohort (VICTORIAN-1 PREVENT; view CT.gov record); Nemaura Medical published its CY Q4 ‘22 (FY Q3 ‘23) business update (press release); and Viatris hosted its Q4 ’22 earnings call (press release; slides). Below, FENIX provides highlights and insights from the respective news items.

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Dexcom’s Project Liberty Motives Are Confusing

At ATTD 2023, Dexcom hosted a symposium where it highlighted “Project Liberty,” a follow-on R&D initiative stemming from Dexcom’s 2018 acquisition of TypeZero. Dexcom said Project Liberty is intended to move AID algorithms beyond T1DM and into a broader subset of patients with diabetes, including T2DM. However, it is not readily apparent as to Project Liberty’s business case. Below, FENIX provides thoughts and hypotheses as to what Dexcom’s strategic rationale could be regarding Project Liberty.

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Ionis Q4 ’22 Earnings; ATTD 2023 Key Press Releases

A series of cardiometabolic-related news items have been observed from Ionis, Dexcom, Ypsomed, Amgen, and MannKind. Below, FENIX provides highlights and insights into the respective news items.

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Medtronic and Esperion CY Q4 ’22 Earnings Updates; Akebia Receives Another FDA Response for Vadadustat; Wegovy and Vadadustat CHMP Opinions; February CHMP Agenda

A series of diabetes-related news items have been observed: Medtronic (press release; slides) and Esperion (press release; slides) hosted their respective CY Q4 ’22 earnings calls; Akebia received another FDA response regarding the vadadustat CRL appeal (press release); and the February CHMP Agenda was posted, including vadadustat and Wegovy (potential) opinions. Below, FENIX provides highlights and insights from the respective news items, including thoughts on Medtronic’s Simplera CGM approval timing.

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Diabeloop Initiates DBL-4pen Trial; Glenmark’s Generic Onglyza Receives Tentative Approval

Two cardiometabolic-related news items have been observed: Diabeloop initiated a trial evaluating its self-learning AID software via the DBL-4pen smartphone app in patients with T2DM in France (SERENIT2; view CT.gov record); and FDA granted tentative approval for Glenmark Pharma’s generic saxagliptin (Onglyza) 2.5mg and 5mg tablets (view Drugs@FDA). Below, FENIX provides highlights and insights from the respective news items, including readthrough from the Diabeloop trial for Sanofi and Novo.

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Biocon CY Q4 ’22 Earnings; Arrowhead Regains Rights to NASH Asset; Zydus Receives Tentative Approval for Generic Invokana

Three cardiometabolic-related news items have been observed: Biocon hosted its FY Q3 ’23 (CY Q4 ’22) earnings call (view press release) and disclosed plans to develop a generic tirzepatide; Arrowhead Pharmaceuticals announced it has regained rights to ARO-PNPLA3, formerly JNJ-75220795, which was being developed in collaboration with Janssen for the treatment of NASH (view press release); and FDA granted tentative approval for Zydus Pharmaceutical’s generic canagliflozin (Invokana; view Drugs@FDA). Below, FENIX provides highlights and insights from the respective news items, including brief thoughts on the potential timing of Biocon’s generic tirzepatide.

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Insulet Acquires AGC Assets

Insulet announced it has acquired assets from Automated Glucose Control LLC (AGC) which include patents and IP licensed from the Francis J. Doyle III laboratory at the University of California, Santa Barbara for $25M. Previously, AGC and Insulet entered into a license agreement and partnership in 2016 based on AGC-acquired patents and IP which were used for the development of the Omnipod 5 (view press release). Below, FENIX provides brief thoughts on the acquisition.

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