Commercial strategy, DTC and HCP promotion, sales forces and launch performance.
The US neurology company named four late-stage assets and said it is building commercial readiness across epilepsy, movement disorders, neurodevelopment and pain.
At the 2026 AGM, Mesoblast's chair described a shift from research-led business to commercial focus, citing roughly US$115 million in fiscal 2026 net sales of Ryoncil.
The Rett syndrome gene therapy developer says validation batches met specifications, with an FDA CMC meeting due this quarter and BLA-pathway feedback expected in the first half of 2027.
The recall, numbered D-0111-2027, stems from an interruption in an ongoing stability programme at a third-party laboratory and covers nationwide US distribution.