Category Archives: Topics

Poxel Q3 ’20 Earnings; NASH Pipeline Updates

Poxel announced its Q3 ’20 earnings and provided an update on its pipeline advancements, but did not host an associated webcast. Interestingly, the Q3 earnings update comes just one month after the company hosted its H1 ’20 results webcast in September 2020. Below, FENIX provides key updates from the press release as well as insight on Poxel’s Imeglimin for T2DM and other NASH development programs.

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DAPA-HF Receives Positive CHMP Opinion; Oramed Oral Insulin Ph3 T2DM Development Update; Livongo Partners with GuideWell

Three diabetes-related news items have been observed: DAPA-HF received a positive CHMP opinion (view here); Oramed announced it has come to an agreement with FDA regarding the Ph3 T2DM program design for its oral insulin (ORMD-0801), with the company planning to initiate the trials in Q4 ’20; and Livongo has partnered with Guidewell (Florida Blue) to expand access to Livongo’s Diabetes platform in Florida. As of this publication, an AstraZeneca press release regarding the DAPA-HF CHMP opinion has not been observed. Below, FENIX provide highlights and insights for the respective news items.

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BI Partners With Yale for HF Digital Solutions Trial; New Lilly Lyumjev T1DM TIR Study; Roche Q3 ’20 Earnings Update

A series of diabetes-related news items have been observed: Boehringer Ingelheim and Yale announced a collaboration to evaluate heart failure digital technologies (press release); Lilly initiated new Lyumjev (ultra rapid-acting lispro) + degludec U100 T1DM MDI TIR study; and Roche hosted its Q3 ’20 earnings call (press release; slides). Below, FENIX provides highlights and insights for the respective news items, including thoughts on how the new Lilly Lyumjev trial likely relates to the recent educational partnership between Lilly and Dexcom (previous FENIX insight).

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Medtronic 2020 Investor Day Highlights

Medtronic hosted its 2020 Investor Day (view slides) and provided updates across its business, including plans to reinvigorate its diabetes business. Importantly, Medtronic disclosed that just yesterday (October 13), the company completed enrollment in its next-gen Synergy CGM sensor pivotal trial. Below, FENIX provides highlights and insights from the diabetes-related portion of the event.

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Two New Novo Ph1 QW Icodec Trials

Two new Ph2 trials for Novo Nordisk’s QW insulin icodec have recently been observed on CT.gov, including a PK/PD study evaluating insulin icodec in patients after being run in on insulin degludec (NCT04582435) and a PK study comparing different injection sites (NCT04582448). Both Ph1 icodec trials are scheduled to initiate ahead of the Ph3 program, which is expected to start in November 2020. Below, FENIX provides an overview and thoughts on the two trials, including readthough to Novo’s QW fixed-ratio combination, icosema (icodec+ QW injectable semaglutide).

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Dario Included in Vitality’s Gateway Flex Program; J&J Q3 ’20 Earnings Update

Dario announced it has been chosen for inclusion in Vitality’s new Gateway Flex offering. J&J also hosted its Q3 ’20 earnings call (press release; slides), and unsurprisingly, there was significant discussion surrounding the recent pause on J&J’s COVID-19 vaccine trial due to an unknown illness in one of the trial participants (view statement from J&J). Below, FENIX provides insight into the impact of Gateway Flex on Dario’s business as well as diabetes-related financial highlights from the J&J earnings call.

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DAPA-HF CHMP Opinion This Week?; October 12-15 CHMP Agenda

The CHMP agenda for this month (October 12-15) has been released, and it includes one notable item, DAPA-HF, as well as several other agenda items. Below, FENIX provides diabetes-related highlights and insights from the October 2020 CHMP agenda.

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First Results for Bayer’s FIDELIO @ Kidney Week; ASN High-impact Trials Released

On Friday Oct 9, ASN posted more sessions for Virtual Kidney Week. Importantly, Bayer’s FIDELIO-DKD trial for finerenone will seemingly have first results presented during Kidney Week, rather than at Virtual AHA (previous FENIX insight). Below, FENIX provides a bit more detail and thought on a dynamic 3-4 weeks between Kidney Week and AHA.

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Novo Launches the First Rybelsus Video DTC campaign; New Omnipod DTC from Insulet

Two new DTC commercials have recently been observed: Novo Nordisk launched a Rybelsus video DTC called “Wake Up” and Insulet initiated an Omnipod video DTC called “Simplify Life with Omnipod.” Of note, this is the first Rybelsus video DTC to be observed since the Rybelsus US approval in September 2019. Below, FENIX provides analyses for both of the DTC commercials, including insight into the ongoing Rybelsus launch.

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