Gamida Cell shares shot higher on Tuesday after its allogeneic cell therapy received US Food and Drug Administration (FDA) approval.
Its drug candidate Omisirge received breakthrough therapy designation, priority review and orphan drug designation from the FDA, sending shares of the Boston-based company nearly 45% higher in midday trading.
In a statement, Gamida said that the approval “(reflects) the unmet need for additional donor sources for stem cell transplant.”
Omisirge is the first allogeneic stem cell transplant therapy to be approved based on a global, randomized Phase 3 clinical study, the company added.
Allogeneic transplant uses cells from a donor, rather than the recipient.
Shares of Gamida traded around US$1.63 in New York.
Gamida’s proprietary nicotinamide (NAM) technology leverages the properties of NAM to enhance and expand cells, which creates allogeneic cell therapy products and candidates that are potentially curative for patients with hematologic malignancies.
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