Inventiva Resumes lani NATiV3 recruitment ahead of schedule, LPFV still in 1H24
Inventiva announced that it has lifted the voluntary pause on recruitment of its phase 3 (NATiV3) trial of lanifibranor in MASH and that sites are resuming screening activities ahead of schedule, starting with 152 sites in the US that have recruited >60% of patients. With the remaining sites expected to resume recruitment in the coming weeks, we believe Inventiva is likely to achieve last patient first visit by 1H24, which would in turn pin the topline readout to its original timeline of 1H26. Additionally, we look forward to topline data from the phase 2 (LEGEND) trial of lanifibranor + empagliflozin (SGLT2 inhibitor) in MASH and T2D in 1Q24. We reiterate our BUY rating and € 10 TP.Inventiva is a clinical stage biotechnology research company delivering therapies in the areas of oncology, fibrosis and rare diseases. The most advanced clinical programs (IVA337 for systemic sclerosis in Non-Alcoholic Steato-Hepatitis and IVA336 for Maroteaux-Lamy syndrome-MPS VI) have demonstrated efficacy in relevant in vivo and in vitro models as well as safety in phase I and phase II clinical trials. Using its in-house drug discovery platform, which covers target validation, screening, chemistry, ADME and pharmacology, Co. is developing an internal oncology and fibrosis discovery pipeline with approaches centered on transcription factors, epigenetics targets and nuclear receptors.
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