Mesoblast (MESO) is an Australian company at the forefront of regenerative therapies with its lead product Remestemcel-L already approved for use in pediatric graft versus host disease ((GVHD)) in Japan marketed as TEMCELL by its partner JCR Pharmaceuticals (TYO:4552).
Mesoblast has commercial rights outside Japan for Remestemcel-L after its acquisition from Osiris Therapeutics (OSIR) following the failure of its trial in patients with adult GVHD. Subsequent royalties are now payable to Smith & Nephew (SNNUF). The FDA has set a prescription Drug User Fee Act action date of September 30, 2020, for Remestemcel-L in pediatric