Shares of  (NASDAQ: MESO) were down more than 61% as of 2:15 p.m. on Friday. The pharmaceutical stock is down more than 54% so far this year.

Mesoblast focuses on allogeneic cellular medicines to treat inflammatory diseases. On Friday, the company said that it had received a Complete Response Letter (CRL) from the Food and Drug Administration (FDA). The CRL is in response to Mesoblast's Biologics License Application (BLA) for Ryoncil (remestemcel-L) to treat pediatric steroid-refractory acute graft-versus-host disease (GVHD), and is requesting more data before the FDA grants marketing approval.

The CRL was actually on a resubmission by the company regarding its BLA after the FDA had earlier raised concerns. The company said it will conduct a controlled study among high-risk adults with GVHD to further test Ryoncil.

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Source Fool.com