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    IVA   FR0013233012

INVENTIVA

(IVA)
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The New England Journal of Medicine Publishes the Results of the Native Phase IIb Clinical Trial with Lanifibranor in Nash

10/20/2021 | 05:07pm EST

Inventiva S.A. announced the publication of the results from its NATIVE (NAsh Trial to Validate IVA337 Efficacy) Phase IIb clinical trial evaluating lanifibranor for the treatment of NASH in the prestigious, peer-reviewed medical journal The New England Journal of Medicine (NEJM). the 24-week clinical trial, lanifibranor, an orally-available small molecule and the only pan-PPAR agonist currently in clinical development for the treatment of NASH, at 1200mg/day met the primary endpoint with a statistically significant reduction of the Steatosis Activity Fibrosis score (SAF), which combines assessments of hepatocellular inflammation and ballooning, with no worsening of fibrosis in the Intention To Treat (ITT2) and the Per Protocol populations (PP3). Lanifibranor also met key secondary endpoints, including NASH resolution with no worsening of fibrosis4 and improvement of liver fibrosis with no worsening of NASH5 in both ITT and PP populations, as well as the composite endpoint of NASH resolution and improvement of liver fibrosis. With these latter results, lanifibranor is the first orally available drug candidate to achieve statistically significant results on the two U.S. Food and Drug Administration (FDA) and European Medicine Agency (EMA) primary endpoints relevant for seeking U.S. accelerated approval and EU conditional approval during Phase III clinical development. The results of NATIVE were reported in June 2020 in accordance with the study protocol and Statistical Analysis Plan design using a single imputation method of missing data, a conservative method that consider missing end-of-study biopsy data as non-responders. The data presented in The New England Journal of Medicine showed additional analyses presented in accordance with the journal requirements using a multiple imputation method of missing end-of-study biopsy data.


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Financials
Sales 2021 5,07 M 5,74 M 5,74 M
Net income 2021 -51,6 M -58,5 M -58,5 M
Net cash 2021 47,3 M 53,6 M 53,6 M
P/E ratio 2021 -9,74x
Yield 2021 -
Capitalization 480 M 541 M 544 M
EV / Sales 2021 85,4x
EV / Sales 2022 11,7x
Nbr of Employees 100
Free-Float 78,3%
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Number of Analysts 7
Last Close Price 11,74 €
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FrÚdÚric Cren Chairman & Chief Executive Officer
Jean Volatier Chief Financial & Administrative Officer
Pierre Broqua Director, Deputy CEO & Chief Scientific Officer
Michael P. Cooreman Chief Medical Officer
Alice Roudot-Ketelers Vice President-Clinical Operations
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