Submits New Information to FDA IND File for SR-aGVHD
Filed with ASX · · 3 pages · English
Melbourne, Australia; October 3 and New York, USA; October 2, 2022: Mesoblast Limited (ASX:MSB; Nasdaq:MESO), global leader in allogeneic cellular medicines for inflammatory diseases, announced today that it has submitted to the U.S. Food and Drug Administration (FDA) substantial new information on clinical and potency assay items identified in the Complete Response Letter (CRL) received from FDA
Earlier from Mesoblast
- MSB Annual Financial Results and Operational Highlights
- Preliminary Final Report
- US$45 Million Private Placement to Major Shareholders
- Reinstatement to Quotation
- Rexlemestrocel-L Improves LVEF, Preceding Reduction in MACE
Later from Mesoblast
- First Quarter Financial Results on Form 6-K
- MSB Q1 Financial Results and Operational Highlights
- Long-Term Survival for Acute GvHD Treatment with Remestemcel
- Extension of Undrawn US$30 million Facility
- Mesoblast Completes Resubmission of BLA to FDA for SR-aGVHD
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