Mesoblast Limited (NASDAQ: MESO) has witnessed a phenomenal run in the year so far. Shares of MESO have risen a whopping 208.2% year to date against the industry's decline of 6.3%. The massive outperformance can mostly be attributed to positive regulatory updates. Image Source: Zacks Investment Research Mesoblast is developing allogeneic (off-the-shelf) cellular medicines for the treatment of severe and life-threatening inflammatory conditions. It is developing product candidates for distinct indications based on its remestemcel-L and rexlemestrocel-L allogeneic stromal cell technology platforms. Remestemcel-L is being developed for inflammatory diseases in children and adults, including steroid-refractory acute graft versus host disease (SR-aGVHD) and biologic-resistant inflammatory bowel disease. Rexlemestrocel-L is being developed for advanced chronic heart failure and chronic lower back pain. The company recently confirmed that it will file its biologics license application (BLA), seeking approval of remestemcel-L (brand name Ryoncil) for the treatment of children with SR- aGVHD, with the FDA next week. Earlier in March 2024, MESO's shares skyrocketed after the FDA informed the company that the available clinical data from the phase III MSB-GVHD001 study of remestemcel-L is adequate ...