Category Archives: Topics

Abbott Q2 ’22 Earnings Update; Lilly to Initiate Fourth Trial in Ph3 QWINT Program; Ionis’s Ph3 Lp(a) HORIZON CVOT Completes Enrollment

Three cardiometabolic-related news items have been observed: Abbott hosted its Q2 ’22 earnings call (press release; view infographic); a fourth trial from Lilly’s Ph3 QW insulin program has been observed (view CT.gov record); and Ionis announced that the Ph3 Lp(a) HORIZON CVOT evaluating has completed enrollment (view CT.gov record). Below, FENIX provides highlights and insights for the respective new items.

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Novartis and J&J Q2 ’22 Earnings Updates

Two cardiometabolic-related news items have been observed: Novartis (press release; slides) and J&J (press release; slides) hosted their respective Q2 ’22 earnings calls. Below, FENIX provides highlights and insights for the respective new items.

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Tirzepatide up for CHMP Opinion; July 18-21 CHMP Agenda; Lilly Initiates QW Insulin T2DM MDI Trial (QWINT-4); UHC Eliminates Insulin OOP Costs

A series of cardiometabolic-related news items have been observed: the CHMP agenda for this month’s meeting (July 18-21) has been released and it appears Lilly’s tirzepatide is up for an opinion; a third trial from Lilly’s Ph3 QW insulin program (BIF; LY3209590) has been observed (view CT.gov record); and UnitedHealthcare announced that starting January 1, 2023, it will eliminate out-of-pocket costs for certain preferred prescription drugs, including insulin and four medical emergency drugs. Below, FENIX provides highlights and insights for the respective new items.

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Abbott Progresses Libre 3 US Launch; New Trial Dasiglucagon Trial for Inreda’s Bi-hormonal AID system; NICE Recommends Amarin’s Vazkepa for Reimbursement in England and Wales

Three cardiometabolic-related news items have been observed: Abbott has recently posted a series of eight new instructional videos on its FreeStyle US YouTube channel (view YouTube Channel) for the Libre 3 CGM; an Inreda-sponsored study has been observed evaluating the feasibility of Zealand’s dasiglucagon in its bi-hormonal closed-loop system (STABLE-1; view CT.gov record); and Amarin announced NICE issued final guidance recommending reimbursement for Vazkepa (icosapent ethyl) in England and Wales. Below, FENIX provides highlights and insights for the respective new items.

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Novo Buys Another PRV; Thoughts on Potential Uses

Novo has reportedly purchased a PRV from Marinus for $110M (view SEC filing). There have been no press releases issued from Novo or Marinus. Of note, Novo previously purchased PRVs from Chemo Research SL and another from Medicines Development for Global Health (view article). However, the company has only used one of its PRVs in late 2020 to expedite FDA’s review of its Wegovy. Now, in addition to the newly acquired PRV from Marinus, Novo is believed to have two PRVs in its pocket. Below, FENIX has conducted an analysis and rationale for where the PRV may be used.

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Lilly to Initiate GGG Ph1 DDI Study

A Lilly-sponsored Ph1 trial has been observed evaluating the effects of Lilly’s GGG tri-agonist (GLP/GCG/GIP) on drug-drug interactions with midazolam, warfarin, and caffeine (view CT.gov record). Below FENIX provides additional details from the trial record as well as insight into how Lilly’s GGG DDI trial is different from prior DDI studies with the incretin class.

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Viatris Recalls Another Batch of Glargine Vials; Intercept’s OCA Meets Primary Endpoint in New Interim Analysis; Dexcom partners with Zillion

Three cardiometabolic-related news items have been observed: Viatris announced a voluntary recall of another batch of its unbranded insulin glargine U100 10mL vials due to a potential missing label (view FDA website); Intercept announced positive topline data from a new interim analysis from its ongoing Ph3 REGENERATE trial evaluating OCA in fibrosis due to NASH; and Zillion announced a partnership with Dexcom to integrate Dexcom’s CGM data with Zillion’s RestoreHealth program. Below, FENIX provides highlights and insights for the respective new items.

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Sema to Replace Metformin as 1L in T2DM?

As a follow-up to Novo’s oral semaglutide ASCEND PLUS primary prevention CVOT being posted to CT.gov (previous FENIX insight), FENIX has conducted an analysis, including thoughts on how Novo may be looking to displace metformin as 1L oral treatment for T2DM.

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Novo Initiates Ph3 H2H Sema vs. Empa Trial; CeQur Launches its Simplicity Insulin Patch Pump; Vertex T1DM Clinical Hold Lifted

Three cardiometabolic-related news items have been observed: a Novo-sponsored Ph3 H2H study (PIONEER START) evaluating semaglutide and empagliflozin in younger patients with newly diagnosed T2DM and obesity has been observed (view CT.gov record); it has been reported that CeQur’s wearable insulin patch (CeQur Simplicity) is entering the next phase of a limited market release (view article); and Vertex announced FDA lifted the clinical hold placed on the Ph1/2 VX-880 trial. Below, FENIX provides highlights and insights for the respective new items.

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