After Almost 4 Years, FDA Says Mesoblast Phase 3 Therapy Data Can Support Resubmission For Serious Complications in Children Following Stem Cell Transplant
Portfolio Pulse from Vandana Singh
The FDA has informed Mesoblast Limited (NASDAQ:MESO) that the clinical data from its Phase 3 study MSB-GVHD001 is sufficient to support a BLA submission for remestemcel-L for pediatric SR-aGVHD. Mesoblast plans to file the resubmission next quarter. This follows a complete response letter from the FDA in August 2023 requiring more data. The FDA had previously supported an accelerated approval pathway for another of Mesoblast's products. MESO shares surged 75.90% to $3.87.
March 26, 2024 | 4:47 pm
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Mesoblast's Phase 3 study data for remestemcel-L for pediatric SR-aGVHD has been deemed sufficient by the FDA for a BLA submission, with plans to resubmit next quarter. Shares jumped 75.90% to $3.87.
The FDA's positive feedback on Mesoblast's Phase 3 study data for remestemcel-L represents a significant regulatory milestone, likely bolstering investor confidence and contributing to the sharp rise in MESO's stock price. The anticipation of a successful BLA submission and potential approval for remestemcel-L in treating pediatric SR-aGVHD could maintain upward pressure on the stock in the short term.
CONFIDENCE 90
IMPORTANCE 95
RELEVANCE 100