Gamida Cell (NASDAQ:GMDA) reported positive topline results from its Phase 3 study of omidubicel in patients with high-risk hematologic malignancies undergoing a bone marrow transplant.
The study achieved its primary endpoint, where the median time to neutrophil engraftment was significantly shorter for patients who received omidubicel, compared with the comparator group. Among patients who were transplanted per protocol, 96% of patients who received omidubicel achieved successful neutrophil engraftment, compared with 88% in the comparator group.
“Omidubicel is the first bone marrow transplant product to receive breakthrough therapy designation from the FDA and has the potential to be the first FDA-approved bone marrow transplant graft,” Julian Adams, Gamida Cell’s CEO, said in a statement.
“We are very pleased with the results of the Phase 3 data reported today, which move us one step closer toward bringing potentially curative therapies to patients,” he added.
The company expects to begin a rolling submission of a biologics license application for omidubicel to the FDA in the fourth quarter of 2020.
