Shares Of Pluristem Therapeutics Surging Following Receipt Of Orphan Drug Designation
Shares Pluristem Therapeutics Inc. (NASDAQ: PSTI), a biotherapeutics company that develops off-the-shelf allogeneic cell therapy products, surged higher by more than 16 percent on Thursday.
Pluristem Therapeutics announced on Thursday that the U.S. Food and Drug Administration (FDA) granted the company's PLX-PAD cells Orphan Drug Designation in the treatment of severe preeclampsia.
Pluristem Therapeutics noted the designation could accelerate time to marketing approval, orphan drug grants, tax credits and a seven-year market exclusivity upon marketing approval.
"Attainment of Orphan Drug Designation for our cells in severe preeclampsia exemplifies our global strategy of bringing cell therapies to patients through accelerated approval pathways," Pluristem's Chairman and CEO Zami Aberman said in the company's press release. "We are encouraged by the US FDA designation that demonstrates Pluristem's commitment to the program and the potential promise it holds to address a serious, unmet medical need faced by pregnant women every year."
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