Category Archives: Dual/triple agonist

vTv Therapeutics to Reduce Workforce by 65%; Innovent Announces Positive Results for Ph1 GLP-1/GCG from Lilly; Nemaura Completes Initial Shipment of CGM Devices to MySugarWatch DuoPack Limited

Three cardiometabolic-related news items have been observed: vTv Therapeutics announced restructuring plans in order to prioritize its Ph3 TTP399 program, including a workforce reduction of 65%; Innovent Biologics announced that results from its Ph1b clinical trial of IBI362 (LY3305677), a dual GLP-1/GCG receptor agonist, for T2DM were presented at the 2021 IDF conference; and Nemaura announced it has completed its initial shipment of sugarBEAT CGM to its UK licensing partner MySugarWatch Limited. Below, FENIX provides highlights and insights for the respective new items.

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Sciwind Biosciences Acquires Worldwide Rights to Sanofi’s GIP Receptor Agonists; Diamyd Pauses Initiation of Ph3 DIAGNODE-3 Trial; AMF Medical’s Sigi Patch Pump Receives Breakthrough Device Designation; FDA Authorizes Sample Size Expansion for Fractyl Health’s Revitalize-1 Pivotal Trial

A series of cardiometabolic-related news items have been observed: Sciwind Biosciences announced it has entered into a WW exclusive licensing agreement to develop and commercialize Sanofi’s GIP receptor agonists; Diamyd Medical announced it has paused the initiation of its Ph3 DIAGNODE-3 trial due to potential contamination in the manufacturing process of the Diamyd diabetes vaccine; AMF Medical announced that its insulin patch pump for closed-loop integration (Sigi) has received Breakthrough Device Designation; and Fractyl Health announced FDA authorized the expansion of its Revitalize-1 pivotal clinical study (formerly REVITA-T2Di) sample size from 288 to 420. Below, FENIX provides highlights and insights for the respective new items.

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Intarcia Files Notice of Opportunity for a Hearing; Provention Bio Advances popPK Model for Teplizumab; Zealand Announces Dapiglutide Topline Results

Three cardiometabolic-related news items have been observed: It has been reported that Intarcia Therapeutics has filed for a Notice of Opportunity for a Hearing with FDA for ITCA-650 (link to WSJ article); Provention Bio announced topline results from preliminary analysis of popPK model; and Zealand announced topline results for Ph1b trial with GLP1-GLP2 dual receptor agonist (dapiglutide). Below, FENIX provides highlights and insights for the respective new items.

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BI/Lilly’s Jardiance Receives FDA Priority Review; Novo’s Wegovy Receives Positive CHMP Opinion; Merck/Bayer Initiate New Ph3 Verquvo Study; Dario Enters Three New Commercial Agreements; Gmax Administers First in Human Dose of GMA106 in Ph1 Obesity Study; Metacrine and Zealand Q3 ’21 Earnings Updates

A series of cardiometabolic-related news items have been observed from BI/Lilly, Novo Nordisk, Zealand, Merck/Bayer, Dario, Gmax Biopharma, and Metacrine. Below, FENIX provides highlights and insights for the respective news items, including an updated projection of the EMPEROR-Preserved PDUFA date.

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Zealand Announces Presentation of Preclinical and Clinical Data on ZP8396 and BI 456906; BING Innovations Launches DigiVibe; Dario Signs Remote Patient Monitoring Services Contracts; National Diabetes Awareness Month Activities

A series of cardiometabolic-related news items have been observed: Zealand announced preclinical data for its amylin analog (ZP8396) and clinical data for its GCG/GLP-1 dual-agonist (BI 456906; out-licensed to Boehringer Ingelheim) were presented at The Obesity Society Annual Meeting; BING Innovations announced the launch of DigiVibe to reduce pain associated with SMBG; Dario announced it has signed two new contracts with regional providers for its Remote Patient Monitoring services for patients living with diabetes and hypertension; and Dexcom (view press release), Insulet (view press release), and DaVita (view press release) announced various activities to recognize National Diabetes Awareness Month and World Diabetes Day. Below, FENIX provides highlights and insights for the respective news items.

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Lilly and Novartis Q3 ’21 Earnings Updates

Today, Lilly (press release; slides) and Novartis (press release; slides) hosted their Q3 ’21 earnings calls. Below, FENIX provides highlights and insights from the respective news items.

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Why A Lexicon Deal for Sota Feels Like Momentum Is Building

Following the EMPEROR-Preserved and FIGARO-DKD data readouts at ESC 2021, it seems as if a deal for Lexicon’s sotagliflozin should be building momentum. Below, FENIX provides thoughts on the quickly evolving HF/CKD market and insight into what a potential deal for sotagliflozin may look like, despite some caveats.

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Lilly Q2 ’21 Earnings Update

Lilly hosted its Q2 ’21 earnings call and provided updates across its CV/Met portfolio, specifically for tirzepatide and Jardiance. Unsurprisingly, much of the call focused on donanemab for the treatment of Alzheimer’s disease following FDA’s June 2021 approval of Aduhelm (aducanamab) for the same treatment. Of note, Lilly disclosed it intends to host an in-person investor event in December 2021 to provide pipeline updates and initial guidance. Below, FENIX provides highlights and insights from the Lilly earnings call.

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Lexicon, Merck, and Intercept Q2 ’21 Earnings Update

Three cardiometabolic-related news items have been observed: Lexicon, Merck, and Intercept hosted their Q2 ’21 earnings calls and provided updates to their respective CV/Met businesses. Below, FENIX provides highlights and insights for the calls.

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Why Lilly Will Terminate GGG; Lilly ADA 2021 Investor Update

Lilly hosted an ADA investor event in which the company covered tirzepatide, tri-agonist GGG, QW basal insulin, oral incretins, and a summary slide of Lilly’s CVRM R&D portfolio. Below, FENIX provides highlights and insights from the event, including why GGG won’t progress beyond Ph2.

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