Gamida Cell Receives FDA Approval for Omisirge®

Cell therapy pioneer, Gamida Cell (Nasdaq: GMDA), has received FDA approval for its allogeneic cell therapy, Omisirge® (omidubicel-onlv).

Omisirge is approved for use in adults and children aged 12 years and older with blood cancers to reduce the time to neutrophil recovery and the incidence of infection following umbilical cord blood transplantation.

Gamida Cell’s shares rose more than 50% following the news.

Highlights

Gamida Cell’s clinical study showed that 87% of patients who received Omisirge achieved neutrophil recovery a median 12 days after treatment, versus a median 22 days in 83% of patients assigned to umbilical cord blood transplantation.

The study also found bacterial or fungal infections by day 100 following transplantation in 39% of patients who received Omisirge, compared with 60% of patients in the control group.

Omisirge’s safety profile is consistent with the expected adverse events of allogeneic hematopoietic stem cell transplantation.

Omisirge is manufactured in Gamida Cell’s GMP manufacturing facility in Kiryat Gat, Israel and is expected to be delivered to transplant centers in the United States within 30 days of the start of manufacturing.

The company’s Phase 3 clinical study results are available in Blood, the official journal of the American Society of Hematology.