Mesoblast Soars 12.76% on FDA Regulatory Progress

Mesoblast's stock surged 12.76% in pre-market trading on July 1, 2025, driven by significant developments in its regulatory interactions with the FDA.

Mesoblast recently held a meeting with the FDA on June 3, 2025, to align on key items for the Biologics License Application (BLA) filing for Revascor®. The FDA provided formal minutes following the meeting, indicating a positive step forward in the regulatory process. This alignment is crucial as it signifies that Mesoblast has met the FDA's requirements for filing the BLA, potentially leading to accelerated approval for Revascor® in the treatment of end-stage heart failure.

The strategic alignment with the FDA, coupled with Mesoblast's robust pipeline and the synergies between its therapies, positions the company as a leader in regenerative medicine. The FDA's alignment on key requirements, including Chemistry, Manufacturing, and Controls (CMC) and potency assays for commercial product release, demonstrates Mesoblast's strong manufacturing capabilities and regulatory preparedness.

Mesoblast plans to submit the BLA for Revascor® by the end of the year, with a focus on achieving accelerated approval. This development is a pivotal moment for Mesoblast, as it brings the company closer to bringing its innovative treatment to patients suffering from ischemic heart failure.