Pipeline updates are highly awaited events in the pharma/biotech sector as they play an important role in deciding whether or not to invest in a particular company. These updates provide information on experimental drugs and at times give an insight into the commercial potential of the candidate once it is successfully developed and commercialized.
Pluristem Therapeutics, Inc. (PSTI) develops placenta-based cell therapies in collaboration with companies like United Therapeutics (UTHR) or through research and clinical institutions. The cells from placenta are derived using the company’s proprietary PluriX therapy and are known as PLX cells.
Pluristem intends to develop and produce cell therapy products for the treatment of multiple disorders using several methods of administration.
Pluristem recently announced that it has submitted its application to the U.S. Food and Drug Administration (:FDA) to grant orphan drug designation to its PLacental eXpanded (PLX-PAD) cells for the treatment of severe preeclampsia.
We note that Pluristem’s PLX cells already enjoys orphan drug designation in the U.S. for the treatment of aplastic anemia and Buerger's disease.
The orphan drug designation will not only accelerate the development of PLX cells but will also benefit Pluristem in various stages of drug development, including faster approval process, seven years of marketing exclusivity following marketing approval and tax credits on certain clinical trials in the U.S.
We are encouraged by Pluristem’s efforts to develop PLX cells for various diseases.
Pluristem currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the same sector include Alexion Pharmaceuticals (ALXN) and Biogen Idec Inc. (BIIB). Both stocks carry a Zacks Rank #1 (Strong Buy).