Mesoblast shares surge as FDA aligns on plans for heart failure treatment

The news: Mesoblast shares lifted in morning trade after the biotech said it had aligned with the US Food and Drug Administration (FDA) on key items for its biologics licence application for its ischemic heart failure treatment Revascor.

The numbers: Mesoblast shares were up 6.8% to $1.77 at 11:20am AEST, having retreated more than 40% since the turn of the year.

The context: The company said it is aligned with the FDA on items regarding chemistry, manufacturing and controls, potency assays for commercial product release, and proposed design and primary endpoint for the confirmatory trial post-approval.

Mesoblast intends to file by the end of the year for accelerated approval for Revascor for certain types of patients.