An evolving COVID-19 treatment paradigm may have foiled Mesoblast Ltd.’s phase III with remestemcel-L in ventilator-dependent patients with moderate to severe acute respiratory distress syndrome (ARDS), CEO Silviu Itescu said, but hope remains in pediatric steroid-refractory acute graft-vs.-host disease (GVHD).
PERTH, Australia – Stem cell therapy company Mesoblast Ltd. saw its stock drop 15% on the news that its allogeneic mesenchymal cell therapy, rexlemestrocel-L (Revascor), failed to meet the primary endpoint of a reduction in hospitalizations in its phase III advanced chronic heart failure trial.
PERTH, Australia – Mesoblast Ltd. inked an exclusive global licensing deal with Novartis AG for the development, manufacture and commercialization of Mesoblast’s mesenchymal stromal cell product remestemcel-L, with an initial focus on the acute respiratory distress syndrome, including that associated with COVID-19, just six weeks after the FDA issued a complete response letter for the therapy as a treatment for steroid-refractory acute graft-versus-host disease.
PERTH, Australia – Mesoblast Ltd. inked an exclusive global licensing deal with Novartis AG for the development, manufacture and commercialization of Mesoblast’s mesenchymal stromal cell product remestemcel-L, with an initial focus on the acute respiratory distress syndrome, including that associated with COVID-19, just six weeks after the FDA issued a complete response letter for the therapy as a treatment for steroid-refractory acute graft-versus-host disease.
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.
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.
PERTH, Australia – Australia’s biopharma sector fared better than the country at large at the end of the financial year that ended June 30, as the country saw GDP fall 7% in the final quarter, the largest drop since 1959. Australia’s trading relationship with China helped the country sidestep the global financial recession of 2008, but the recent divide between the U.S. and China is also putting a wedge between Australia and China relations.
PERTH, Australia – Australia’s biopharma sector fared better than the country at large at the end of the financial year that ended June 30, as the country saw GDP fall 7% in the final quarter, the largest drop since 1959.
While the FDA’s Oncologic Drugs Advisory Committee (ODAC) shared some of the agency’s concerns about uncertainties surrounding Mesoblast Ltd.’s Ryoncil (remestemcel-L), it voted 9-1 Aug. 13 that the mesenchymal stromal cell (MSC) product showed evidence of efficacy as a treatment for steroid-refractory acute graft-vs.-host disease (GVHD) in children.
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.
