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Mesoblast Submits Completed Biologics License Application for Ryoncil to the FDA

Mesoblast filed the final module of the rolling BLA submission, covering quality control and manufacturing, with the FDA on January 31. The Company has requested Priority Review of the BLA by the FDA under the product

Benzinga · 02/03/2020 11:19

Mesoblast filed the final module of the rolling BLA submission, covering quality control and manufacturing, with the FDA on January 31. The Company has requested Priority Review of the BLA by the FDA under the product candidate’s existing Fast Track designation for SR-aGVHD. If approved, RYONCIL is expected to be launched in the US in 2020.