Osiris Therapeutics, Inc. Release: Prochymal New Drug Submission Granted Priority Review by Health Canada

COLUMBIA, Md.--(BUSINESS WIRE)--Osiris Therapeutics, Inc. (NASDAQ: OSIR) announced today that the Biologics and Genetic Therapies Directorate of Health Canada has completed its initial evaluation and accepted for full review the company’s New Drug Submission (NDS) of Prochymal (remestemcel-L), an adult stem cell therapy for the treatment of graft vs. host disease (GvHD). Based on a separate review of summary clinical data, Health Canada has notified Osiris that the application has been granted Priority Review, shortening the examination period from 300 to 180 days. If successful, Prochymal would become the world’s first approved stem cell therapy.
MORE ON THIS TOPIC