Mesoblast (MESO,MSB.AX) has shared an update about its progress with the U.S. Food and Drug Administration. The company is working toward faster approval for its heart failure treatment, Revascor, aimed at patients with reduced heart function and inflammation. It's also seeking to expand the approved uses for Ryoncil, its treatment for adults with a serious immune condition called steroid-refractory acute graft versus host disease.
In the first week of June, Mesoblast held a Type B meeting with FDA under its Regenerative Medicines Advanced Therapy (RMAT) designation for REVASCOR to discuss components of a potential filing for a Biologics License Application (BLA). There was general alignment on items regarding chemistry, manufacturing & controls (CMC), potency assays for commercial product release, and proposed design and primary endpoint for the confirmatory trial post-approval.
The Company said it will await the final minutes from FDA in order to provide detailed feedback and timelines for potential filing.
In early July, Mesoblast has an upcoming meeting with FDA to discuss a pivotal trial of Ryoncil in adults with steroid refractory acute graft versus host disease (SR-aGvHD). This trial will be conducted with the NIH-funded Bone Marrow Transplant Clinical Trials Network (BMT-CTN), the objective being to extend the product's label from children to adults with SRaGvHD. Ryoncil is the first and only mesenchymal stromal cell product approved by the FDA for any indication, the company said.
The company noted that Ryoncil became commercially available for purchase in the United States on March 28, 2025, within one quarter of receiving FDA approval to treat children with SR-aGvHD. More than 20 transplant centers will have been onboarded by the end of the quarter, exceeding the company's expectations at product launch.
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