Published on 27 Mar 2024 on Zacks via Yahoo Finance
Mesoblast (MESO) to File Pediatric GVHD Drug BLA, Stock Up
Mesoblast Limited’s MESO shares surged 78.6% on Mar 26, after an encouraging regulatory update from the FDA for its lead product candidate, remestemcel-L, which is being developed for the treatment of pediatric patients with steroid-refractory acute graft versus host disease (SR-aGVHD).
Post additional scrutinization, the FDA informed the company that the available clinical data from the phase III MSB-GVHD001 study of remestemcel-L is adequate to support the resubmission of the biologics license application (BLA) for remestemcel-L to treat pediatric patients with SR-aGVHD.
Mesoblast is currently gearing up to file the BLA resubmission during the second quarter of 2024, seeking to address all remaining product characterization issues.