Gamida Cell Ltd. (NASDAQ: GMDA) is a biopharma company that is focused on utilizing cell therapy to create innovative therapeutics. Shares of the cell therapy company are rallying 43% through early trading on Tuesday, April 18, 2023. Over the past three months, Gamida Cell has seen average daily volume of 1.66 million shares. However, volume of 47.04 million shares or dollar volume of around $75.26 million, has already exchanged hands through early trading.
Shares of Gamida Cell are climbing after the company announced it has received FDA approval for its allogeneic cell therapy, Omisirge® (omidubicel-onlv), to be used in patients aged 12 and older with hematologic malignancies undergoing umbilical cord blood transplantation. Omisirge has been granted breakthrough therapy designation, priority review, and orphan drug designation.
The approval is based on a global, randomized Phase 3 clinical study, where Omisirge demonstrated a reduced time to neutrophil recovery and lower infection rates compared to standard cord blood. This advancement may increase access to stem cell transplants and improve patient outcomes, particularly for racially and ethnically diverse patients who often struggle to find a fully matched donor.
Omisirge is manufactured using proprietary nicotinamide (NAM) technology, which enhances and expands the number of progenitor cells. It is now available in the United States, and Gamida Cell is pursuing strategic partnerships to support its launch and commercialization.
“The approval of Omisirge is a significant development in hematopoietic stem cell transplantation,” said Steven M. Devine, M.D., Chief Medical Officer at the National Marrow Donor Program® (NMDP)/Be The Match®. “Patients who are Black or African American have just a 29% chance of finding a match via the donor registry vs. a 79% chance for patients who are White.3 Adding Omisirge as a new donor source may help increase access to stem cell transplant for patients from racially or ethnically diverse backgrounds who struggle to find a fully matched donor in the registry.”
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