Mesoblast (ASX:MSB) said that it will meet with the US Food and Drug Administration in July to discuss a pivotal trial of Ryoncil, seeking to extend the drug's label from children to adults with steroid-refractory acute graft versus host disease, according to a Thursday Australian bourse filing.
The trial is to be conducted with the National Institutes of Health-funded Bone Marrow Transplant Clinical Trials Network.
The company also advanced an accelerated approval pathway for Revascor in the treatment of patients with ischemic chronic heart failure with reduced ejection fraction and inflammation.
The firm held a type B meeting with the US FDA in early June under its regenerative medicines advanced therapy designation for Revascor to discuss components of a potential filing for a biologics license application.
It achieved alignment with the regulator on items regarding chemistry, manufacturing, and controls, as well as potency assays for commercial product release, and proposed design and primary endpoint for the confirmatory trial post-approval, the filing said.
The firm's shares rose over 3% in recent trading on Thursday.
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