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BioWorld - Thursday, June 11, 2026
Home » Ryoncil

Articles Tagged with ''Ryoncil''

Stem cells

Mesoblast stock tanks on news of FDA CRL for Ryoncil BLA in pediatric GVHD

Oct. 6, 2020
By Tamra Sami
PERTH, Australia – Regenerative medicine company Mesoblast Ltd. saw its stock drop 37% on the news that it received an FDA complete response letter to its BLA for Ryoncil (remestemcel-L) for the treatment of pediatric steroid-refractory acute graft-vs.-host disease.
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Stem cells

Mesoblast stock tanks on news of FDA CRL for Ryoncil BLA in pediatric GVHD

Oct. 2, 2020
By Tamra Sami
PERTH, Australia – Regenerative medicine company Mesoblast Ltd. saw its stock drop 37% on the news that it received an FDA complete response letter to its BLA for Ryoncil (remestemcel-L) for the treatment of pediatric steroid-refractory acute graft-vs.-host disease.
Read More
Financial chart, downward arrow

Mesoblast sees stock tumble 31% ahead of FDA adcom meeting

Aug. 11, 2020
By Tamra Sami
PERTH, Australia – Australian regenerative medicine company Mesoblast Ltd. saw its stock tumble more than 30% following the release of briefing documents from the FDA ahead of an Aug. 13 advisory committee meeting to review the company’s BLA for Ryoncil (remestemcel-L) for steroid-refractory acute graft versus host disease (SR-aGVHD) in children.
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FDA icons

Back to ‘normal’? FDA adcom meets, but questions loom over others

June 17, 2020
By Mari Serebrov
In a step toward what may become the new normal, at least for now, the Pediatric Oncology Subcommittee of the FDA’s Oncologic Drugs Advisory Committee is meeting virtually Wednesday and Thursday to review pediatric development plans for four cancer drugs.
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Coronavirus and coins

Australia’s Mesoblast raises $90M to scale up stem cell therapy manufacturing to treat COVID-19 ARDS

May 19, 2020
By Tamra Sami
PERTH, Australia – Australian stem cell company Mesoblast Ltd. completed a capital raising of AU$138 million (US$90 million) to scale up manufacturing of its allogeneic cell therapy, remestemcel-L, to treat COVID-19 acute respiratory distress syndrome (ARDS).
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Australia’s Mesoblast raises $90M to scale up stem cell therapy manufacturing to treat COVID-19 ARDS

May 13, 2020
By Tamra Sami
PERTH, Australia – Australian stem cell company Mesoblast Ltd. completed a capital raising of AU$138 million (US$90 million) to scale up manufacturing of its allogeneic cell therapy, remestemcel-L, to treat COVID-19 acute respiratory distress syndrome (ARDS).
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Respiratory infection

Mesoblast reports 83% survival in ventilator-dependent COVID-19 patients following stem cell therapy

April 28, 2020
By Tamra Sami
PERTH, Australia – Australian stem cell company Mesoblast Ltd.’s shares were up nearly 39% on the news that its allogeneic cell therapy showed an 83% survival rate in ventilator-dependent COVID-19 patients with moderate to severe acute respiratory distress syndrome (ARDS) treated at New York’s Mount Sinai Hospital.
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Respiratory infection

Mesoblast reports 83% survival in ventilator-dependent COVID-19 patients following stem cell therapy

April 24, 2020
By Tamra Sami
PERTH, Australia – Australian stem cell company Mesoblast Ltd.’s shares were up nearly 39% on the news that its allogeneic cell therapy showed an 83% survival rate in ventilator-dependent COVID-19 patients with moderate to severe acute respiratory distress syndrome (ARDS) treated at New York’s Mount Sinai Hospital.
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Stem cells

FDA accepts Mesoblast’s BLA for pediatric GVHD stem cell therapy under priority review

April 8, 2020
By Tamra Sami
PERTH, Australia – Australian stem cell therapy company Mesoblast Ltd. announced that the FDA has accepted its BLA for priority review for its allogeneic mesenchymal precursor cell therapy, remestemcel-L, for children with acute steroid-refractory graft-vs.-host disease (aGVHD).
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FDA accepts Mesoblast’s BLA for pediatric GVHD stem cell therapy under priority review

April 7, 2020
By Tamra Sami
PERTH, Australia –Australian stem cell therapy company Mesoblast Ltd. announced that the FDA has accepted its BLA for priority review for its allogeneic mesenchymal precursor cell therapy, remestemcel-L, for children with acute steroid-refractory graft-vs.-host disease (aGVHD).
Read More
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