Mesoblast Trades Higher After Heart Failure Cell Therapy Receives Orphan Drug Status
Mesoblast Limited (NASDAQ: MESO) product rexlemestrocel-L has received Orphan Drug Destination from the U.S. Food and Drug Administration for prevention of gastrointestinal bleeding in patients with left ventricular assist device.
The Orphan Drug Act provides for granting special status to a drug or biological product to treat a rare disease or condition upon request of a sponsor.
"We are very pleased that the FDA has granted our heart failure cell therapy product candidate, Revascor, Orphan Drug designation for use in patients with LVADs to prevent mucosal bleeding, including from the gastrointestinal (GI) tract,” said Mesoblast CEO Dr. Silviu Itescu in a statement. “We look forward to our upcoming meeting with the FDA to discuss a potential approval pathway under the product's existing Regenerative Medicine Advanced Therapy (RMAT) designation for this life-threatening condition."
Mesoblast shares traded higher by 6.4% to $4.97 at time of publication. The stock has a 52-week range between $8.78 and $3.35.
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