Mesoblast’s BLA for remestemcel-L accepted by FDA

Mesoblast announced that the FDA has agreed that Mesoblast can submit on a rolling basis a Biologics License Application, or BLA, for its allogeneic cellular medicine remestemcel-L in children with steroid-refractory acute Graft Versus Host Disease, or SR-aGVHD. Mesoblast will submit each module of the BLA to the FDA on a rolling basis as it is completed. The rolling process will provide opportunity for ongoing and frequent communication, and during this process the Company expects it will be able to adequately address any substantial matters raised by the FDA. Mesoblast has previously received Fast Track designation from the FDA for remestemcel-L in SR-aGVHD and is eligible for priority review once the BLA filing is completed and accepted by the FDA. Mesoblast expects to submit the first module shortly.

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