Mesoblast Gives Positive Update About Potential FDA Application For Heart Failure Therapy: Retail Sees ‘Inflection Point’

The company is also looking forward to a meeting with the FDA in early July to discuss a trial of Ryoncil in adults with steroid-refractory acute graft-versus-host disease.

Mesoblast (MESO) said on Thursday it is awaiting the final minutes from the U.S. Food and Drug Administration (FDA) to provide timelines for potential filing for its late-stage product candidate Revascor. Nasdaq-listed shares of the company rose over 3% by Thursday morning.

The biotechnology company is seeking to file an application for the approval of Revascor for the treatment of patients with ischemic chronic heart failure, characterized by an enlarged heart and insufficient blood flow to the organs and extremities of the body. The condition is estimated to affect 2% of the adult population of the United States.

During the meeting held in the first week of June, 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.

The firm added that it is now awaiting the final minutes from the FDA to determine the timeline for a potential approval filing.

The company is also looking forward to a meeting with the FDA in early July to discuss a trial of Ryoncil in adults with steroid-refractory acute graft versus host disease (SR-aGvHD). Ryoncil is currently approved for the treatment of pediatric patients two months of age and older, and the company is looking to expand the scope of its treatment to adults.

On Stocktwits, retail sentiment around Mesoblast rose from ‘neutral’ to ‘bullish’ over the past 24 hours while message volume remained at ‘high’ levels.

A Stocktwits user applauded the update from the company and said that it is at its “inflection point.”

MESO stock is down by about 41% this year but up by nearly 71% over the past 12 months.

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