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Orphan Status Sought for PSTI Drug

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Pluristem Therapeutics, Inc. (PSTI - Free Report) recently announced that it has filed documents with the US Food and Drug Administration (FDA) seeking orphan drug status for using its PLacental eXpanded (PLX) cells to treat patients suffering from aplastic anemia.

Aplastic anemia refers to a rare, serious disorder resulting from the destruction of blood-forming stem cells (hematopoietic stem cells, or HSCs) in the bone marrow. We note that in normal circumstances, HSCs develop into only red blood cells, white blood cells and platelets. However, all blood types are deficient in patients suffering from aplastic anemia.

In such cases, the patients are either supported with blood transfusions ahead of a bone marrow transplant or with drugs that cause the immune system to be suppressed. Pluristem stated in its press release that the US market for bone marrow transplants (including patients suffering from aplastic anemia) is worth approximately $1.3 billion annually.

We note that on being provided with orphan drug status by the FDA the PLX cell therapy, for treating aplastic anemia patients, will enjoy multiple benefits including seven years of marketing exclusivity (from the day the candidate is cleared by the FDA) in the US for the indication.

We remind investors that Pluristem enjoys orphan drug status for using PLX cells to treat patients suffering from Buerger's disease since August 2011. The disease results in inflammation and clotting of blood vessels thereby reducing the flow of blood in these areas.

Our Recommendation

We currently have a Neutral recommendation on Pluristem. The stock carries a Zacks #3 Rank (Hold rating) in the short run.

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