Abivax SA announced that the US Food and Drug Administration (FDA) recently provided valuable feedback in the context of the end-of-phase-2 meeting with guidance and a path forward to bring ABX464 into phase 3 clinical testing for the treatment of ulcerative colitis and subsequent potential marketing authorization submission and commercialization. This includes comments on study design, dose selection and the statistical analysis plan. The scientific advice meeting with the European Medicines Agency (EMA) is scheduled for early first quarter of 2022. Taking into account the guidance from FDA and potential recommendations from EMA, Abivax intends to finalize the phase 3 study design and update its IND for ABX464 for the treatment of ulcerative colitis in first quarter of 2022. Subject to regulatory clearance, Abivax plans to enroll the first patient into its pivotal program in second quarter of 2022.