Tag Archives: Gan & Lee

Gan & Lee GZR4 IND Granted FDA Clearance; Viatris Q2 ’22 Earnings Update

Two cardiometabolic-related news items have been observed: Gan and Lee announced FDA accepted its IND application for a novel QW ultra-long-acting insulin (GZR4); and Viatris hosted its Q2 ’22 earnings call (press release; slides). Below, FENIX provides highlights and insights for the respective new items.

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Lexicon Q2 ’22 Earnings Update; CLEAR Outcomes CVOT Reaches 100% MACE Accumulation; Esperion Q2 ’22 Earnings Update; Dexcom ONE Available with Prescription in UK; Gan & Lee Dose First Patient in Ph2 GZR18 Trial for T2DM; Structure Therapeutics Advances Diabetes & Obesity Clinical Program

A series of cardiometabolic-related news items have been observed: Lexicon (press release; slides) and Esperion (press release; slides) hosted their respective Q2 ’22 earnings calls; Dexcom announced the Dexcom ONE rt-CGM system is now listed on the NHS England, Wales, Scotland, and Northern Ireland drug tariffs; Gan & Lee recently announced the first patient has been dosed in its Ph2 study evaluating the company’s GLP-1RA (GZR18) in T2DM; and Structure Therapeutics announced it has completed dosing in the Ph1 SAD trial for its small molecule oral GLP-1RA (GSBR-1290). Below, FENIX provides context and insight on the respective news items.

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Rockley Photonics and Medtronic Collaboration for Non-invasive Wearables; Gan & Lee Dose First Patient with GZR18 in Ph1 T2DM Study; Xeris Biopharma and Zealand Q4 and FY ‘21 Earnings Updates

A series of cardiometabolic-related news items have been observed: Rockley Photonics Holdings Limited announced a development partnership with Medtronic to integrate Rockley’s Bioptx biomarker sensing platform with Medtronic’s devices across various healthcare settings; Gan and Lee announced the first patient has been dosed in their Ph1 study evaluating the company’s investigational GLP-1RA (GZR18) in T2DM; and Zealand (press release; slides) and Xeris (press release) hosted their respective earnings calls. Below, FENIX provides highlights and insights for the respective new items.

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Tandem Hosts 2021 R&D Webinar; FDA Accepts IND for G&L’s Novel GLP-1 Analogue; BD Announces Name of Diabetes Spin Off Company

Three cardiometabolic-related news items have been observed: Tandem hosted its 2021 R&D webinar (view here; slides) and provided an in-depth review of the company’s product pipeline, including the t:slim X3, t:sport (Mobi), and a future patch pump; Gan & Lee announced FDA accepted its IND application for a novel GLP-1 analog, referred to as GZR18; and Becton Dickinson announced that its diabetes spinoff business company will be named “embecta [pronounced em-BECK-tah]. Below, FENIX provides highlights and insights for the respective new items.

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G&L Bs-glargine Completes Ph3; Adocia’s BC Lispro Cleared for Pivotal Ph3 in China; Dario Signs National Digital Behavioral Health Contract

A series of cardiometabolic-related news items have been observed: Gan & Lee announced the conclusion of its two Ph3 bs-glargine studies; Adocia announced that its partner, Tonghua Dongbao, received clearance to initiate a Ph3 trial for uRAI BioChaperone Lispro in China; and Dario announced it was selected as the digital behavioral health provider for an undisclosed US national health plan. Below, FENIX provides highlights and insights for the respective news items.

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