Pluristem Submits FDA Orphan Drug Application for Preeclampsia



this is Anna Maria Chen with corporate profile calm reporting from Wall Street on pluristem therapeutics ticker PST I on the Nasdaq pluristem therapeutics is a biotech company and leading developer of placenta based cell therapies the company's main technology is their plx cell therapy pluristem just announced it has submitted an application for orphan drug designation to the US Food and Drug Administration for its plx p ad cells and the treatment of severe preeclampsia preeclampsia is one of the leading known causes of premature births stillbirths and early neonatal and maternal death having just recently established the company's preeclampsia steering committee comprised of key medical opinion leaders this orphan drug application submission is an important step in advancing the company's preeclampsia development program but tremendous unmet medical need makes this indication when a plurality the company reported they're hopeful that the very strong preclinical data for plx cells in preeclampsia will translate into similar results at the clinical level orphan drug designation may qualify a company for several benefits including 7-year market exclusivity tax credits the FDA of guidance on clinical studies and orphan drug grants pluristem has successfully received orphan drug designation from the FDA for its plx cells in two other indications the treatment of aplastic anemia and the treatment of Buerger's disease again I'm Anna Maria Chen reporting from Wall Street on pluristem the therapeutics took her PST I on the Nasdaq is definitely a buy

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