Category Archives: Other

Tzield (teplizumab) Label and Website Analysis

FDA recently approved Provention Bio’s teplizumab, branded as Tzield, to delay the onset of Stage 3 T1DM in adult and pediatric patients aged 8 years and older with Stage 2 T1DM (previous FENIX insight). Additionally, Provention hosted an investor call on Friday, November 18, 2022, to discuss the approved Tzield label, pricing, and commercialization plans (webcast). Below FENIX has conducted a Tzield label and website analysis, including highlights and insights from the investor call (label; previous FENIX insight).

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Teplizumab Approved as Tzield; Sernova Implants First Two Patients in Second Cohort of Ph1/2 T1DM Trial

Two cardiometabolic-related news items have been observed: Provention Bio announced the FDA approval of teplizumab to delay the onset of T1DM; and Sernova announced the first two patients in the second cohort of its Ph1/2 trial in T1DM have been implanted (view CT.gov record). Below, FENIX provides highlights and insights from the respective news items.

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Medtronic Launches Extended Wear Infusion Set; Dario Q3 ’22 Earnings Update; Versanis Bio Initiates Ph2 Bimagrumab Study in Obesity

Three cardiometabolic-related news items have been observed: Medtronic announced the US launch of its extended wear infusion set; Dario hosted its Q3 ’22 earnings call and provided updates on its digital health portfolio (press release); and Versanis Bio has initiated a Ph2 trial evaluating the safety and efficacy of Q12W bimagrumab monotherapy or in combination with semaglutide in overweight or obese patients (view CT.gov record). Below, FENIX provides highlights and insights from the respective news items.

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Tandem Reports Positive Results from Control-IQ T2DM Feasibility Study

Tandem announced positive results from its Control-IQ T2DM feasibility study (2IQ; view CT.gov record) were presented at the Diabetes Technology Meeting on November 10, 2022. Below, FENIX provides brief thoughts on the positive data from the Control-IQ feasibility study and the market potential of a T2DM AID system.

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AZ and Zealand Q3 ’22 Earnings Updates; Novo Smart Pen Integration with Libre

Three cardiometabolic-related news items have been observed: AstraZeneca (press release; slides) and Zealand (press release; slides) hosted their Q3 ‘22 earnings calls, where Zealand talked about its dual agonist’s weight loss data; and Novo Nordisk announced its smart pens can now connect to Abbott’s FreeStyle LibreLink app in the UK. Below, FENIX provides context and insight on the respective news items.

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Lexicon, Xeris, and Ionis Q3 ’22 Earnings Updates; Esperion Hosts 2022 R&D Day

A series of cardiometabolic-related news items have been observed: Lexicon (press release), Xeris (press release), and Ionis (press release; slides) hosted their respective Q3 ’22 earnings calls; and Esperion hosted its 2022 R&D webinar (press release; webcast) where it provided a review of the company’s pipeline, including its oral PCSK9i and ACL inhibitor programs. Below, FENIX provides highlights and insights for the respective news items.

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Amgen Post-AHA 2022 Pipeline Update; Senseonics, Bayer, and MannKind Q3 ’22 Earnings Updates

A series of cardiometabolic-related news items have been observed: Amgen hosted a post-AHA investor call and provided updates on its General Medicine Portfolio (view slides; view webcast); and Senseonics (press release), Bayer (press release; slides), and MannKind (press release; slides) hosted their Q3 ’22 earnings calls. Below, FENIX provides highlights and insights from the respective news items.

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Lilly Connected Pen US Launch in 2022; Lannett Partners with Ypsomed; Eversense to Integrate with Apple; Viatris Q3 ’22 Earnings Update; November CHMP Agenda

A series of CVRM-related news items have been observed: Lilly announced plans to launch its Tempo Personalized Diabetes Management Platform to select US clinics in 2022; Lannett announced a partnership with Ypsomed for insulin pen delivery; Ascensia announced the Eversense implantable CGM now integrates with Apple Health; Viatris hosted its Q3 ’22 earnings and provided brief updates to its bs-insulin portfolio divestiture (press release; slides); and the November CHMP agenda (view here) has been released. Below, FENIX provides highlights and insights from the respective news items.

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EMPA-KIDNEY Demonstrates 28% RRR @ ASN 2022; Sernova to Expand Ph1/2 Patient Cohort; Creative Medical Cell Therapy IND Granted FDA Clearance; Senseonics/Ascensia Collaborate with NPG to Expand Eversense CGM Access; Amgen Q3 ’22 Earnings Update

A series of cardiometabolic-related news items have been observed: Lilly/BI and Oxford jointly announced that the EMPA-KIDNEY trial demonstrated a 28% RRR in the primary composite endpoint, with results simultaneously published in NEJM (view publication); Sernova announced it received FDA authorization to expand enrollment for its Ph1/2 Cell Pouch trial (view CT.gov record); Creative Medical announced FDA accepted its IND application for its AlloStem cell therapy system; Senseonics and Ascensia announced a collaboration with The Nurse Practitioner Group (NPG) to provide in-office and at-home Eversense procedures; and Amgen hosted its Q3 ’22 earnings call (press release; slides). Below, FENIX provides highlights and insights for the respective new items.

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Insulet, Provention Bio, Madrigal, and Regeneron Q3 ’22 Earnings Updates

A series of cardiometabolic-related news items have been observed: Insulet (press release), Provention Bio (press release), and Regeneron (press release; slides) hosted their Q3 ’22 earnings calls and; Madrigal issued a press release for its Q3 ‘22 earnings, though it did not host an associated webcast. Below, FENIX provides highlights and insights for the respective news items.

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