Mesoblast shares up following its drug update

Oct 03, 2022

Mesoblast Limited (ASX: MSB) has submitted to the U.S. Food and Drug Administration (FDA) substantial new data on clinical and potency assay items recognised in the Complete Response Letter received from FDA in September 2020 to the Biologics License Application (BLA) for remestemcel-L in the treatment of children with steroid-refractory acute graft versus host disease.

The Company was in discussion with FDA since receiving CRL and the substantial new information submitted to the Investigational New Drug (IND) file for remestemcel-L in the treatment of children with SR-aGVHD, as guided by FDA, represents an important milestone in the MSB’s complete response to the FDA.

At AEST 11:41 AM, MSB shares are trading at AU$0.840, up 7.692% from its previous close. 

 

 

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