The investigation focuses on whether the company issued misleading and/or false statements and/or failed to disclose information pertinent to investors. On August 11, 2020 The FDA released briefing materials for the August 13, 2020, meeting of the Oncologic Drugs Advisory Committee. The meeting was to discuss the marketing application of Mesoblast for Ryoncil (remestemcel-L) for the treatment of steroid-refractory acute graft-versus-host disease in pediatric patients. According to the FDA briefing documents, it was “unclear” if these study results are “relevant” to the proposed indication. On August 11, shares of Mesoblast fell by nearly 35% based on this news.
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