Mesoblast - An important next several months
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.Mesoblast is engaged in the development of regenerative medicine products. Co. has leveraged its proprietary technology platform, based on specialized cells known as mesenchymal lineage adult stem cells ("MLCs"), to establish a portfolio of late-stage product candidates. Co.'s allogeneic, "off the shelf" product candidates target advanced stages of diseases with high, unmet medical needs including cardiovascular conditions, orthopedic disorders, immunologic and inflammatory disorders and oncology and hematologic conditions. Each MLC-derived product candidate has technical characteristics, target indications, reimbursement strategy, commercialization potential, and partnering opportunities.
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