GMDA - Gamida Cell meets all secondary endpoints in late-stage Omidubicel study in blood cancer
Gamida Cell (GMDA) jumps 15% premarket after announcing that the Phase 3 study of omidubicel, an investigational advanced cell therapy in development for patients in need of bone marrow transplant, met all three of its secondary endpoints. The Phase 3 study was designed to evaluate the safety and efficacy of omidubicel in patients with hematologic malignancies undergoing a bone marrow transplant compared to a comparator group of patients who received a standard umbilical cord blood transplant.In May, Gamida Cell reported that omidubicel achieved its primary endpoint, demonstrating a highly statistically significant reduction in time to neutrophil engraftment.The prespecified secondary endpoints of the study were the proportion of patients who achieved platelet engraftment by day 42, the proportion of patients with Grade 2 or Grade 3 bacterial or invasive fungal infections in the first 100 days following transplant, and the number of days alive and out of the hospital following transplant.All three secondary
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Gamida Cell meets all secondary endpoints in late-stage Omidubicel study in blood cancer