(By Balaseshan) Pluristem Therapeutics Inc. (NASDAQ: PSTI) reported the status of orphan drug application for aplastic anemia, which was acknowledged by the U.S. Food and Drug Administration (FDA) as a rare disease.
FDA has updated the company on its application to designate Pluristem's PLacental eXpanded (PLX) cells orphan drug status in the treatment of aplastic anemia.
The FDA acknowledged that aplastic anemia is a rare disease with prevalence in the United States of less than 200,000. This serves as confirmation that aplastic anemia is an indication for which candidate treatments are eligible for orphan drug status.
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The FDA has also requested that Pluristem provide additional information and data for further analysis before the FDA can determine if the PLX cells can qualify for orphan drug designation for aplastic anemia.
Orphan drug designation qualifies a company for several benefits under the Orphan Drug Act of 1983 (ODA), as amended. These benefits include a 7-year period of orphan drug exclusivity upon product approval, a tax credit for certain clinical testing expenses for the orphan drug, written guidance on the non-clinical and clinical studies needed to obtain marketing approval of an orphan drug, and orphan drug grants.
"We look forward to providing the additional information that the FDA needs in connection with our orphan drug status application for Aplastic Anemia. We appreciate the very productive working relationship we have with the FDA, as we present PLX cells as candidates for the treatment of a range of therapeutic indications," stated Zami Aberman, Chairman and CEO of Pluristem.
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PSTI closed Tuesday's regular session down 0.63% at $3.17. The stock has been trading between $2.02 and $5.00 for the past 52 weeks.