Mesoblast shares soar on FDA approval for Ryoncil therapy
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The news: Shares in dual-listed biotech Mesoblast surged in early trading on the ASX, after the US Food and Drug Administration (FDA) approved the company's product Ryoncil as the first mesenchymal stromal cell therapy in the US.
The numbers: Mesoblast shares were up 30.8% to $2.59 by 10:43am AEDT, having climbed more than 700% this year.
Ryoncil is the first FDA-approved therapy for children aged two months and older with steroid-refractory acute graft versus host disease (SR-aGvHD), a life-threatening condition with high mortality rates.
In a phase three trial of children with SR-aGvHD, 70% achieved an overall response by day 28 of treatment with Ryoncil, a measure that predicts survival of the condition.
Around 10,000 patients undergo an allogeneic bone marrow transplant in the US every year, 1,500 of whom are children. Approximately 50% of those develop aGvHD and almost half of those do not respond to steroids, the recognised first-line treatment.
The context: Ryoncil will now be available in the US at transplant centres and other treating hospitals.
In September, Mesoblast said it would raise up to USD50 million ($72.7 million) from its largest shareholder Gregory George if it received FDA approval for Ryoncil. The company said the proceeds from the raising would be used to ensure it is well-capitalised for Ryoncil's commercial product launch.
What they said: "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 Mesoblast's chief executive Silviu Itescu.
"... 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."
The source: ASX announcement
