Tag Archives: Inventiva

Hengrui Licenses GLP-1RA-Based Assets to US Biotech; Inventiva Announces Positive DMC Recommendation for Ph3 MASH Trial; US Senate Releases Report on Anti-Obesity Medication Pricing; Biocon Q1 ’24 Earnings

A series of cardiometabolic-related news items have been observed from Hengrui Pharmaceuticals, Inventiva, US Senate HELP Committee, and Biocon. Below, FENIX provides highlights and insights for the respective news items.

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Inventiva Interim Ph2a MASH Results; Madrigal Announces $600M Public Offering; 89bio Initiates Ph3 ENLIGHTEN-Fibrosis MASH Trial

Three cardiometabolic-related news items have been observed: Inventiva announced positive interim Ph2a LEGEND MASH trial results (press release; slides); Madrigal priced an upsized $600M public offering (view press release); and 89bio’s Ph3 ENLIGHTEN-Fibrosis trial in MASH has been posted to CT.gov (view CT.gov record). Below, FENIX provides highlights and insights for the respective new items.

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Lilly Initiates Retatrutide T2DM Pivotal Program; Medtronic CY Q4 ’23 (FY Q3 ’24) Earnings; February CHMP Agenda; Inventiva Pauses Ph3 MASH Trial; Better Therapeutics Receives BDD for MASH

A series of cardiometabolic-related news items have been observed from Lilly, Medtronic, EMA, Inventiva, and Better Therapeutics. Below, FENIX provides highlights and insights for the respective news items, including thoughts on Lilly’s Ph3 T2DM pivotal program for retatrutide.

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Wegovy Advertising Paused Due to High Demand; Inventiva Ph2 Lanifibranor T2DM and NAFLD Results; FDA Accepts Gan & Lee’s Bs-Aspart BLA

Three cardiometabolic-related news items have been observed: Ro has reportedly paused its Wegovy advertising due to the ongoing supply shortage (view article); Inventiva announced positive topline results from its Ph2 trial evaluating lanifibranor in patients with T2DM and NAFLD (view press release); and Gan & Lee announced FDA accepted the BLA for its biosimilar insulin aspart (view press release). Below, FENIX provides highlights and insights into the respective news items, including thoughts on the ongoing Wegovy supply issues.

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Inventiva Updates Lanifibranor NASH Development Program; Galectin Completes Ph2b/3 NAVIGATE Study Enrollment; Novo Signs Stemcell Deal with Fujifilm

Three cardiometabolic-related news items have been observed: Inventiva announced changes to the clinical development of lanifibranor, including a new Ph3 trial in NASH and compensated cirrhosis (view press release); Galectin announced enrollment completion for its Ph2b/3 NAVIGATE study evaluating belapectin in patients with liver cirrhosis caused by NASH (view press release; CT.gov record); and Fujifilm Cellular Dynamics announced an iPSC-derived cell therapy license agreement with Novo Nordisk (view press release). Below, FENIX provides highlights and insights for the respective news items, including readthrough from Inventiva’s new NASH clinical development strategy.

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Know Labs Prepares for FDA Pre-submission Meeting; FDA Accepts Inventiva’s IND for Ph2 Combination (lanifibranor+empa) Trial; Dexcom CGMs Integrated With Happy Bob

Three cardiometabolic-related news items have been observed: Know Labs issued a press release outlining its planned activities ahead of an FDA pre-submission meeting for its non-invasive Bio-RFID technology (press release); Inventiva announced that FDA has accepted Inventiva’s IND for its Ph2 combination lanifibranor+empa trial (LEGEND) in NASH +T2DM; and Harald AI announced that its subscription-based, diabetes management app, Happy Bob, has been integrated with Dexcom CGMs. Below, FENIX provides highlights and insights for the respective new items.

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Novartis’s Entresto Marketing Under DOJ Investigation?; Inventiva’s Ph2a Lanifibranor + Empa Trial (LEGEND); Merck and Sanofi Q3 ’21 Earnings Updates; Roche and Zur Rose Group Collaboration

A series of cardiometabolic-related news items have been observed: It has been reported that Novartis received a request from DOJ regarding details about the marketing and pricing of Entresto since 2016 (view article); Inventiva announced the design of its Ph2a combination (lanifibranor+empa) trial (LEGEND) in patients with NASH and T2DM; Merck (press release; slides) and Sanofi (press release; slides) hosted their respective Q3 ’21 earnings calls; and Roche and the Zur Rose Group announced their collaboration of healthcare products and solutions. Below, FENIX provides highlights and insights for the respective news items.

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