Mesoblast plots next steps to gain approval of twice rejected Ryoncil

Australian allogenic cellular medicines developer Mesoblast (ASX:M SB) closed down 3.4% at A$1.265 yesterday, after it provided an update on the path to approval for its lead-product candidate Ryoncil (remestemcel-L) in the treatment of pediatric and adult steroid-refractory acute graft versus host disease (SR-aGVHD).

This followed a Type A meeting held with the US Food and Drug Administration (FDA), which clarified that the key remaining issue for pediatric approval is providing further evidence that the potency assay will assure the consistent efficacy of commercial product.

Just last month, the FDA issued a complete response letter (CRL) to Mesoblast’ Biologics License Application (BLA) resubmission for remestemcel-L, having slapped the first CRL on the BLA in 2020.