Elyse Shapiro's questions to MESOBLAST (MESO) leadership • FY 2025
Question
Elyse Shapiro of Canaccord Genuity Group sought more details from the recent FDA meeting regarding the adult GVHD trial, inquired about timelines for the inflammatory bowel disease (IBD) program, and asked if RYONCIL sales could include off-label use.
Answer
CEO Silviu Itescu confirmed alignment with the FDA to study RYONCIL in combination with Jakafi for severe adult GVHD. For IBD, he stated a key opinion leader group is finalizing a trial design for medically refractory colitis, with an update expected this quarter. He acknowledged that while they cannot track off-label use by individual physicians, the product is predominantly used for its approved pediatric GVHD indication, supplemented by a formal compassionate use program for adults.