It is going to be a busy next several months for Mesoblast. The company recently completed filing the biologics license application (BLA) for Ryoncil (remestemcel-L) with the FDA for approval for the treatment of pediatric steroid-refractory acute graft versus host disease (aGvHD). Mesoblast should be notified by the end of March whether the BLA has been accepted and whether it will have a six-month priority review or a 10-month standard review. Additionally, data from the Revascor DREAM-HF1 Phase III trial in 566 advanced heart failure patients is expected by the middle of 2020. Data from the MPC-06-ID 404-patient trial in lower back pain is also expected around the middle of the year.
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