Osiris Therapeutics, Inc. Receives FDA Fast Track Status For Its Crohn’s Disease Stem Cell Therapy And Clearance To Start Phase III Clinical Trial

BALTIMORE--(BUSINESS WIRE)--Osiris Therapeutics, Inc. (NASDAQ: OSIR) announced today that PROCHYMAL™ has received Fast Track designation from the U.S. Food and Drug Administration, expediting the development of the stem cell treatment for Crohn’s Disease that does not respond to standard therapies. Additionally, Osiris has received clearance to conduct a Phase III clinical trial using PROCHYMAL to treat this resistant form of Crohn’s Disease. The Phase III program was developed in consultation with FDA, and if successful, will be the last phase of testing before the company seeks full approval for Crohn’s Disease.
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