INmune Bio announces plans to submit FDA BLA for CORDStrom

INmune Bio (INMB) announced, following a Type C meeting with the U.S. Food and Drug Administration, FDA, its intent to submit a Biologics License Application, BLA, in the US and Marketing Authorization Application, MLA, in the UK and EU supported by data from the MissionEB clinical trial investigating CORDStrom as a disease-modifying therapy for treating RDEB in pediatric patients. The Company reports results of a double-blinded, randomized, placebo-controlled study, known as “MissionEB,” investigating CORDStrom for treatment of RDEB in pediatric patients, which evidence a favorable benefit-risk profile in support of the intended applications for marketing authorization.