Pluristem (NASDAQ:PSTI) has had a productive FY18 to date. The company is advancing PLX-PAD in its Phase III study of critical limb ischemia (CLI) and Phase II study of intermittent claudication (IC), with the latter expecting results in early 2018. Additionally, the company received an orphan designation for PLX-R18 for acute radiation syndrome (ARS) currently in non-human primate studies and expanded its Phase I study for support of stem cell transplant to additional sites. We value Pluristem at $202m.
Orphan designation for ARS
Pluristem is currently planning a pivotal non-human primate study for PLX-R18 for the treatment ARS and are in discussions with the NIH to finance the study. The company recently received an orphan designation for the program, which will entitle the company to seven years of market exclusivity (although we do not believe this is necessary), FDA protocol guidance, grants, and US tax breaks.
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