Reported Earlier, Mesoblast Notified By The U.S. FDA That Available Clinical Data From Phase 3 Trial Appear Sufficient To Support BLA Submission For Remestemcel-L In Children with Steroid-Refractory Acute Graft Versus Host Disease (SR-aGVHD)
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Mesoblast has been informed by the U.S. FDA that the clinical data from its Phase 3 trial seems adequate to support a Biologics License Application (BLA) submission for Remestemcel-L in treating children with Steroid-Refractory Acute Graft Versus Host Disease (SR-aGVHD).
March 26, 2024 | 5:48 am
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Mesoblast's Phase 3 trial data for Remestemcel-L has been deemed sufficient by the FDA to support a BLA submission for treating SR-aGVHD in children.
The FDA's positive feedback on Mesoblast's Phase 3 trial data for Remestemcel-L significantly boosts the company's prospects for obtaining approval for this treatment. This development is likely to be viewed positively by investors, potentially leading to an increase in stock price in the short term due to the enhanced likelihood of market entry and revenue generation from this new treatment.
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