ASX:MSBBiotechs
Mesoblast (ASX:MSB) Is Up 8.7% After Strong Ryoncil Debut And FDA BLA Milestone - Has The Bull Case Changed?
In July 2026, Mesoblast reported that the FDA had accepted its Biologics License Application for rexlemestrocel‑L in preventing life‑threatening gastrointestinal bleeding in end‑stage heart failure patients with LVADs, while the therapy continued to benefit from Orphan Drug and RMAT designations under newly clarified, more flexible FDA guidance for rare diseases.
Separately, Mesoblast disclosed record Ryoncil net revenue of US$36,000,000 for the quarter and US$115,000,000 for its first full...