Category Archives: Other

Insulet Initiates Omnipod 5 US Broad Launch; Arecor Buys Tetris Pharma; Sanofi/Optum Partner for Insulin Affordability

A series of diabetes-related news items have been observed: Insulet announced the full market release of its Omnipod 5 hybrid closed-loop system; Arecor is acquiring Tetris Pharma who is partnered with Xeris for UK/EU/CH Ogluo commercialization (view Xeris press release); and Sanofi/Optum have partnered to reduce the cost of insulin to uninsured patients (press release). Below, FENIX provides context and insight on the respective news items.

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Novo’s QW Insulin Icodec Meets Primary Endpoints in ONWARDS 3 and 4; AZ and Alnylam Q2 ’22 earnings updates; Better Therapeutics Meets Secondary Endpoint in BT-001 Pivotal Trial in T2DM

A series of cardiometabolic-related news items have been observed: Novo announced topline results from the QW insulin icodec Ph3 ONWARDS 3 and ONWARDS 4 trials in T2DM; AZ (press release; slides) and Alnylam (press release; slides) hosted their respective earnings calls; and Better Therapeutics (BT) announced positive secondary endpoint results for its BT-001 pivotal clinical trial in T2DM and held an associated investor call (view webcast). Below, FENIX provides highlights and insights for the respective new items.

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Dexcom G7 Delayed in US; Dexcom, Pfizer, Biocon, Sanofi, and Teladoc Q2 ’22 Earnings Updates

A series of cardiometabolic-related news items have been observed: Dexcom (press release; slides), Pfizer (press release; slides), Biocon (press release), Sanofi (press release; slides), and Teladoc (press release; slides) hosted their respective Q2 ’22 earnings calls. Importantly, Dexcom disclosed the G7 FDA review has been delayed due to updates needed for the app. Below, FENIX provides highlights and insights from the respective earnings calls.

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vTv Receives $10M Investment from CinPax, LLC; Oramed Reaches 50% Enrollment in Second Ph3 Oral Insulin Trial; Esperion Establishes Scientific Advisory Board

Three cardiometabolic-related news items have been observed: vTv announced it received a $10M investment from CinPax; Oramed announced it has reached over 50% enrollment in its second Ph3 oral insulin trial in T2DM; and Esperion established a Scientific Advisory Board to support pipeline and LCM initiatives. Below, FENIX provides highlights and insights for the respective new items.

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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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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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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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