Completion of Pivotal Phase III Trial for Pediatric GVHD
A pivotal Phase III trial for pediatric steroid-refractory acute graft versus host disease successfully met its primary endpoint, showing long-term survival benefits lasting over 4 years.
Regulatory Progress for Remestemcel
New data from a second potency assay has been provided to the FDA, and a meeting is scheduled in March to discuss potential approval pathways.
Successful Cost Containment Strategies
Cash burn for operating activities was reduced by 25% in the last quarter compared to the same period in FY 2023.
Rare Pediatric Disease Designation
Revascor received both rare pediatric disease designation and orphan drug status from the FDA for treating hypoplastic left heart syndrome based on promising trial results.
RMAT Designation for Chronic Low Back Pain
Rexlemestrocel received RMAT designation for chronic low back pain, with a pivotal Phase III trial underway to potentially support FDA approval.