Stock Alert: Gamida Cell Shares Surge 60% In Premarket

(RTTNews) - Shares of Gamida Cell Ltd. (GMDA) are soaring over 60% in pre-market today, after the company announced positive topline results from its Phase 3 clinical study evaluating the safety and efficacy of omidubicel, an investigational advanced cell therapy in development as a potential life-saving treatment option for patients in need of bone marrow transplant.

The median time to neutrophil engraftment was 12 days for patients randomized to omidubicel compared to 22 days for the comparator group. Neutrophil engraftment is a measure of how quickly the stem cells a patient receives in a transplant are established and begin to make healthy new cells, and rapid neutrophil engraftment has been associated with fewer infections and shorter hospitalizations.

"Omidubicel is the first bone marrow transplant product to receive Breakthrough Therapy Designation from the U.S. Food and Drug Administration and has the potential to be the first FDA-approved bone marrow transplant graft. 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," said Julian Adams, chief executive officer of Gamida Cell.

Further, the company noted that it expects to begin to submit its biologics license application for omidubicel to the FDA on a rolling basis in the fourth quarter of this year.

The stock has been trading in the range of $2.60 - $7.92 for the past one year, and closed Monday's trade at $4.54, up 14 cents or 3.18%. GMDA is currently trading at $7.20, up $2.66 or 60.57% in the pre-market session.