GMDA - Gamida posts positive results from late-stage omidubicel study

Gamida Cell (GMDA) announces positive results from a Phase 3 clinical study of its advanced cell therapy omidubicel in certain patients with hematologic malignancies.Gamida said that it expects to submit a Biologics License Application for the treatment to the U.S. FDA in the second half of 2021.The phase 3 study was an international, multi-center, randomized trial of omidubicel that was designed to evaluate the safety and efficacy of omidubicel in patients with high-risk hematologic malignancies undergoing a bone marrow transplant compared to a comparator group of patients who received a standard umbilical cord blood transplant.The study results showed that omidubicel resulted in faster hematopoietic recovery, fewer bacterial and viral infections and fewer days in hospital, Mitchell Horwitz, principal investigator and professor of medicine at the Duke Cancer Institute said.The company had announced positive top-line results from its Phase 3 study study of omidubicel, in May last year.

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Gamida posts positive results from late-stage omidubicel study