Category Archives: Insulin Delivery

Novo to Initiate Ph1 Sema+Dapa FDC Ph1 Trial; ProKidney Publishes Data Supporting MoA of REACT in Patients with Diabetic CKD; Cytokinetics Announces Date for Omecamtiv FDA Adcom; Hygieia licenses d-Nav program in Israel

A series of cardiometabolic-related news items have been observed: a two-part Ph1 Novo-sponsored study evaluating a semaglutide/dapagliflozin FDC has been observed (view CT.gov record); ProKidney recently announced the publication of data from an MoA study of its Renal Autologous Cell Therapy (REACT) in Kidney International Reports (view publication here); Cytokinetics announced FDA informed the company the omecamtiv adcom has been scheduled for December 13, 2022; and Hygieia announced it licensed its d-Nav insulin management system to Movement Group in Israel. Below, FENIX provides highlights and insights for the respective new items.

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Thoughts after ATTD and ADA 2022

Now that we’re on the other side of ADA 2022, FENIX provides provocative thoughts below on various items in the cardiometabolic space. Included are thoughts about Lilly, Novo, Sanofi, Dexcom, Abbott, Medtronic, Bigfoot, and Beta Bionics.

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ADA 2022 Key Press Releases (June 5-6)

On the third and fourth days of ADA 2022, seven cardiometabolic-related news items were observed from Abbott, Bigfoot, BI/Lilly, Intercept, Amarin, Vertex, and Sernova. Below, FENIX provides context and analysis for the announcements.

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ADA 2022 Key Press Releases (June 4)

On the second day of ADA 2022, six cardiometabolic-related news items were observed from Lilly, ADA, Insulet, vTv Therapeutics, and One Drop. Below, FENIX provides context and analysis for the announcements.

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MannKind to Acquire Zealand’s V-Go T2DM Patch Pump; Sernova/Evotec Collaboration for Beta Cell Therapy; AACE Updates NAFLD Guidelines

Three cardiometabolic-related news items have been observed: MannKind announced plans to acquire Zealand’s V-Go insulin delivery device; Sernova and Evotec announced an exclusive global strategic partnership to develop an implantable iPSC-based beta cell replacement therapy and hosted an associated investor call (listen to webcast here); and AACE has updated its NAFLD practice guidelines which favor GLP-1RAs (view guidelines). Below, FENIX provides highlights and insights for the respective new items.

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Movano and Embecta Q1 ’22 Earnings Updates; Hygieia Launches d-Nav Clinical Partnership Program in Michigan

Three cardiometabolic-related news items have been observed: Movano (press release) and Embecta (press release; slides) hosted their respective Q1 ‘22 earnings calls; and Hygieia announced the launch of its d-Nav Clinical Partnership Program for endocrinology practices treating patients with T2DM. Below, FENIX provides highlights and insights for the respective new items.

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Zealand and Dario Q1 ’22 Earnings Updates; NexImmune, Yale, and JDRF research collaboration for T1DM

Three cardiometabolic-related news items have been observed: Zealand (press release; slides) and Dario (press release) hosted their respective Q1 ’22 earnings calls; and NexImmune recently announced a two-year research partnership with Yale and JDRF for the development of a therapy to delay/prevent T1DM. Below, FENIX provides highlights and insights for the respective new items.

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Insulet, Vertex, MannKind, and Intercept Q1 ‘22 Earnings Updates

A series of cardiometabolic-related news items have been observed: Insulet (press release), Vertex (press release), MannKind (press release), and Intercept hosted their respective Q1 ‘22 earnings calls. Below, FENIX provides highlights and insights for the respective new items.

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Novo Q1 ’22 London Earnings; Lilly Initiates Second Trial in Ph3 QWINT Program; Ionis, Provention Bio, Lexicon, and Lannett Q1 ’22 Earnings Updates

A series of cardiometabolic-related news items have been observed: Novo Nordisk hosted its post-Q1 ’22 earnings event (see previous FENIX insight on Q1 ’22 Novo earnings from April 29); a second trial from Lilly’s Ph3 QW insulin program (BIF; LY3209590) has been observed (view CT.gov record); Lexicon (press release), Ionis (press release; slides), Provention Bio (press release), and Lannett (press release) hosted their respective Q1 ‘22 earnings calls. Below, FENIX provides highlights and insights for the respective new items.

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Tandem, Amarin, and Regeneron Q1 ’22 Earnings Updates

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

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