MESO Stock Surges 80% in a Month After FDA Approval of GVHD Drug

Core Viewpoint - Mesoblast Limited (MESO) has experienced an 80% increase in share price within one month following FDA approval of remestemcel-L for treating steroid-refractory acute graft versus host disease (SR-aGVHD) in children aged two months and older, marking a significant milestone for the company as it launches its first approved product [1][2]. Company Summary - The FDA approval of remestemcel-L, branded as Ryoncil in the U.S., is expected to provide Mesoblast with a steady income stream as the company prepares for the product launch [2]. - Mesoblast's shares have surged 202.9% over the past six months, contrasting with a 4.8% decline in the industry [3]. - The approval was based on a phase III study where 70% of patients treated with remestemcel-L achieved an overall response by Day 28, indicating a positive prognosis for survival in aGVHD [4]. - No patients discontinued Ryoncil treatment due to laboratory abnormalities, with over 85% completing the full course without interruption [5]. Pipeline and Future Prospects - Mesoblast is exploring the expansion of Ryoncil's label to include adult patients with SR-aGVHD, with a late-stage study currently underway [6]. - The company is also evaluating Ryoncil for inflammatory bowel disease indications, including ulcerative colitis and Crohn's colitis [6]. - Another late-stage candidate, rexlemestrocel-L, is being developed for heart failure and chronic low back pain (CLBP), with FDA support for an accelerated approval pathway in patients with end-stage ischemic heart failure [9]. - Mesoblast initiated patient enrollment for a late-stage study of rexlemestrocel-L in CLBP, focusing on pain reduction and quality of life improvements [10].