Mesoblast Limited (NASDAQ:MESO) stock is trading higher Thursday after the company announced the U.S. Food and Drug Administration (FDA) approved Ryoncil.

The Details: Ryoncil is the first FDA approved therapy for children aged 2 months and older with steroid-refractory acute graft versus host disease (SR-aGvHD).

Each year in the U.S., around 10,000 patients undergo an allogeneic bone marrow transplant, including 1,500 children. About 50% of these patients develop acute graft versus host disease, and nearly half of them do not respond to steroid treatment.

In a Phase 3 study, 70% of children with SR-aGvHD achieved an overall response by day 28 of treatment with Ryoncil. Treatment was not discontinued or interrupted in any patient for any laboratory abnormality, and the full course was completed without interruption in more than 85% of patients.

"We are very pleased that the FDA has granted approval of RYONCIL and are proud of the company's commitment to the GVHD community in bringing this important new treatment to children and families with no other acceptable options," said Silviu Itescu, CEO of Mesoblast.

"We will continue to work closely with FDA to obtain approval of our other late-stage products, including REVASCOR for cardiovascular diseases and rexlemestrocel-L for inflammatory pain indications, as well as expanding the indications for RYONCIL in both children and adults with inflammatory conditions."

MESO Price Action: At the time of writing, Mesoblast stock was up 35.8% at $16.64, according to data from Benzinga Pro.

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