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Biotech Stocks Facing FDA Decision in August 2023

Mesoblast
Mesoblast

The FDA decision on Mesoblast Ltd.’s (MESO) Remestemcel-L, proposed for the treatment of children with steroid-refractory graft versus host disease, is due on August 2, 2023.

Remestemcel-L is an investigational allogeneic cell therapy consisting of culture-expanded mesenchymal stem cells derived from the bone marrow of an unrelated donor. It is designed to work by downregulating the production of proinflammatory cytokines, increasing production of anti-inflammatory cytokines, and enabling recruitment of naturally occurring anti-inflammatory cells to involved tissues.

This is the company’s second attempt to secure FDA approval for Remestemcel-L.

The FDA had declined to approve Remestemcel-L for pediatric steroid-refractory acute graft versus host disease in October 2020, requiring the company to run at least one more trial to generate more evidence of the drug’s effectiveness.

MESO closed Friday’s (Jul.28, 2023) trading at $4.00, down 3.61%.