JERUSALEM--(BUSINESS WIRE)--Gamida Cell Ltd., developer of stem cell therapeutics, announced today that it has reached an agreement under a Special Protocol Assessment (SPA) with the U.S. Food and Drug Administration (FDA) on the design of the global, pivotal, historical controlled registration study of StemEx® for the treatment of hematological malignancies. Gamida Cell is developing StemEx® in a Joint Venture with Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA).
