Mesoblast's Lead Drug Candidate Goes Under FDA Priority Review For Bone Marrow Transplant Complications In Kids

Mesoblast Ltd MESO rallied after the FDA agreed to review the company's lead drug candidate, remestemcel-L, on a priority basis, more than two years after first rejecting it.
The drug is an investigational therapy that comprises culture-expanded mesenchymal stromal cells derived from the bone marrow of an unrelated donor.
The product is under priority review for children suffering from steroid-refractory acute graft versus host disease (SR-aGVHD).
The FDA said it considered Mesoblast's resubmitted biologics license application a "complete response" and would fast-track remestemcel-L's review process. The agency said it would decide by August 2.
The resubmission contains new long-term survival data for children enrolled in the Phase 3 trial through at least four years and new outcome data following remestemcel-L use in high-risk disease activity.
Last week, Mesoblast reported Q4 earnings, with cash on hand at the end of the quarter was $67.6 million.
Mesoblast has been granted Regenerative Medicine Advanced Therapy designation for rexlemestrocel-L for chronic lower back pain associated with degenerative disc disease. It looks forward to further interactions with the FDA, aiming to enroll the first patients in the pivotal trial by mid-year.
Price Action: MESO shares are up 10.56% at $3.35 during the premarket session on the last check Wednesday.
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