- Thinly traded micro cap Pluristem Therapeutics (NASDAQ:PSTI) is up 20% premarket on robust volume in response to its announcement that the FDA has designated Phase 3-stage PLX-PAD cell therapy for Fast Track review for the treatment of critical limb ischemia (CLI) in patients who are not candidates for revascularization.
- Fast Track status provides for more frequent interactions with the FDA review team and a rolling review of the marketing application.
- PLX cells are mesenchymal-like adherent stromal cells derived from full-term human placentas that may be administered without the need for HLA matching. According to the company, PLX-PAD (peripheral artery disease) cells have demonstrated the ability to stimulate the growth of new blood vessels in preclinical models inducing muscle tissue regeneration and improving muscle function.
- Now read: Pluristem Therapeutics Inc.: A Biotech Company Inspired By Life
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