Mesoblast (MESO) has released an update.
Mesoblast Limited, a leader in allogeneic cellular medicines, has been notified by the FDA that its clinical data for remestemcel-L is adequate for a BLA submission to treat children with steroid-refractory acute graft versus host disease. The company expressed confidence in refiling the BLA in the next quarter, following the FDA’s constructive feedback. Mesoblast is known for its extensive portfolio of anti-inflammatory cellular therapies and has a robust global intellectual property presence, with plans to provide off-the-shelf cellular medicines globally.
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