Category Archives: Uncategorized

Novo Hosts ADA 2022 Investor Event

Novo Nordisk hosted its 2022 ADA investor event primarily focusing on its obesity and QW insulin portfolio (view slides). Of note, management emphasized GLP-1RA class growth, SELECT’s upcoming interim analysis, plans to study even higher doses of semaglutide in T2DM, and the feasibility of a cagrisema H2H trial vs. tirzepatide. Below are highlights and insights from the call.

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Abbott Announces Libre 3 Clearance; Lexicon Resubmits Sota NDA; Dexcom Denies Insulet Acquisition Speculation

Three cardiometabolic-related news items have been observed: Abbott issued a press release addressing the recent FDA clearance of its Freestyle Libre 3 (view press release); Lexicon announced it has resubmitted the sota HF NDA; and Dexcom issued a press release responding to recent media and market speculation that the company was in the process of acquiring Insulet (view press release). Below, FENIX provides highlights and insights for the respective new items.

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May 16-19 CHMP Agenda; Glyscend Therapeutics Completes Ph1 GLY-200 Trial in T2DM

Two cardiometabolic-related news items have been observed: The CHMP agenda for this month’s meeting (May 16-19) has been released; and Glyscend Therapeutics announced the completion of its single and multiple ascending dose (SAD/MAD) Ph1 GLY-200 trial in 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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Novo Highlights CV Risks of Diabetes in Unbranded Campaign Featuring Anthony Anderson; Xeris Q1 ’22 Earnings Update

Two cardiometabolic-related news items have been observed: Novo has launched a new iteration of its “Get Real About Diabetes” campaign focusing on CV risk in T2DM (view article); and Xeris hosted its Q1 ‘22 earnings call (press release). 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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Beta Bionics Insulin-only iLet Pivotal Trial Results @ ATTD 2022; Vertex’s Ph1/2 VX-880 Trial Placed on Clinical Hold

Two cardiometabolic-related news items have recently been observed: Beta Bionics presented results from its insulin-only bionic pancreas pivotal trial at ATTD 2022 (press release); and Vertex issued a press release detailing updates to its Ph1/2 VX-880 trial, including that FDA has placed a clinical hold on the study (press release). Below, FENIX provides highlights and insights from the respective news items.

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Novo, Dexcom, AZ, Sanofi, Biocon, and Teladoc Q1 ’22 Earnings Updates

A series of cardiometabolic-related news items have been observed: Novo (press release; slides), Dexcom (press release; slides), AZ (press release; slides), Sanofi (press release; slides), Biocon (press release), and Teladoc (press release; slides) hosted their respective Q1 ’22 earnings calls. Below, FENIX provides highlights and insights from the respective earnings calls.

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Novo Reports First QW Basal Insulin Icodec Ph3 Data

Novo announced topline results from its first QW basal insulin icodec Ph3 program (ONWARDS 2) comparing icodec to degludec in 526 patients with T2DM switching from QD insulin. Data demonstrated a statistically superior 0.93% reduction in A1C with icodec vs. 0.71% reduction with degludec. Below, FENIX provides thoughts into ONWARDS 2 icodec results.

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