The Mesoblast Limited (ASX: MSB) share price has soared 38% higher after the biotech business announced positive US news.
US update
The Mesoblast share price recently sank 30% after a worrying US FDA report.
But today the company announced that the Oncologic Drugs Advisory Committee (ODAC) of the US Food and Drug Administration (FDA) voted overwhelmingly in favour that the available data supports the effectiveness of its remestemcel-L (RYONCIL) in pediatric patients with steroid-refractory acute graft versus the host disease.
The ODAC is an independent panel of experts that evaluates the efficacy and safety of data and makes recommendations to the FDA. Although the FDA will consider the recommendation, the final decision is made solely by the FDA. The recommendations by the panel are non-binding.
Mesoblast chief medical officer Dr Fred Grossman
said: “Steroid-refractory acute graft versus host disease is an area of extreme need, especially in vulnerable children under 12 years old where there is no approved therapy. We are very encouraged by today’s outcome and are committed to working closely with the FDA as they complete their review of our submission regarding approval of RYONCIL for this life-threatening complication of an allogenic bone marrow transplant.”
Summary
This is clearly great news for Mesoblast, it has passed an important step in the process. However, I’m not a medical or FDA expert, so I can’t say for certain what will happen next or how much earnings Mesoblast will be able to generate from this. Biotechs are somewhat hard to judge, like commodity businesses. I’m happy to leave investing to others and focus on different ASX growth shares.
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