Pluristem Therapeutics Inc (PSTI)

[FDApproved]

PLX cell therapy was granted an orphan drug designation by the FDA for the treatment of graft failure and incomplete hematopoietic recovery following hematopoietic cell transplantation (HCT).

The FDA’s Office of Orphan Drug Products grants orphan status to support development of medicines for underserved patient populations, or rare disorders. Orphan drug designation provides to the Company certain benefits, including market exclusivity upon regulatory approval, if received, exemption of FDA application fees and tax credits for qualified clinical trials.

Pluristem was also granted a patent titled “Methods for Treating Radiation or Chemical Injury” for PLX-R18 cell therapy. This important patent, issued by the European Patent Office, expands the company’s IP assets to include a new set of indications related to the bone marrow’s inability to produce blood cells, such as acute radiation syndrome (ARS), autoimmune diseases such as aplastic anemia, genetic disorders, chemotherapy, radiation therapy, and side effects from other treatments.