Why Gamida Cell (GMDA) Shares Are Surging Today

Gamida Cell Ltd’s GMDA are jumping Tuesday premarket as the FDA approved Omisirge (omidubicel-onlv), an allogeneic cord blood-based cell therapy for adult and pediatric patients 12 years and older with hematologic malignancies, ahead of the scheduled May 1 PDUFA date.
The approval covers patients planned for umbilical cord blood transplantation following a myeloablative conditioning regimen (treatment such as radiation or chemotherapy).
The approval of the single intravenous dose, composed of human allogeneic stem cells from a donor’s umbilical cord blood that are processed and cultured with nicotinamide (a form of vitamin B3), was based on a study of 125 subjects with blood cancer.
The study found that 87% randomized to receive Omisirge achieved neutrophil recovery with a median of 12 days following treatment with the product.
That compared to 83% of subjects randomized to receive umbilical cord blood transplantation and who achieved neutrophil recovery with a median of 22 days.
About 100 days following transplantation, bacterial or fungal infections were seen in 39% of subjects receiving Omisirge versus 60% of subjects in the control group who received umbilical cord blood.
Gamida Cell announced several major restructuring moves late last month to bring Omisirge to market.
Price Action: GMDA shares are up 49.1% at $1.67 during the premarket session on the last check Tuesday.

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