FDA ACCEPTS MESOBLAST’S BIOLOGICS LICENCE APPLICATION FOR RYONCIL™ AND AGREES TO PRIORITY REVIEW
Mesoblast Limited - American Depositary Shares (MESO)
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Source: GlobeNewswire
NEW YORK, April 01, 2020 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq: MESO; ASX:MSB), global leader in cellular medicines for inflammatory diseases, today announced that the United States Food and Drug Administration (FDA) has accepted for priority review the Company’s Biologics License Application (BLA) filing for RYONCILTM (remestemcel-L), its allogeneic cell therapy for the treatment of children with steroid-refractory acute graft versus host disease (SR-aGVHD). The FDA has set a Prescription Drug User Fee Act (PDUFA) action date of September 30, 2020, and if approved, Mesoblast will make RYONCIL immediately available in the United States. A Priority Review designation will direct overall attention and resources to the evaluation of applications for drugs that, if approved, would be significant improvements in the safety or effectiveness of the treatment, diagnosis, or prevention of serious conditions when compared to standard applications. The FDA has advised that they are pl
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- Mesoblast Limited (NASDAQ: MESO) was downgraded by analysts at Jefferies Financial Group Inc. from a "buy" rating to a "hold" rating.MarketBeat
- ISCT Hails Landmark US FDA Approval of RYONCIL as Major Milestone for MSC Field [Yahoo! Finance]Yahoo! Finance
- Mesoblast Limited (NASDAQ: MESO) had its price target raised by analysts at Piper Sandler from $11.00 to $15.00. They now have an "overweight" rating on the stock.MarketBeat
- Pluri Congratulates Mesoblast on FDA Approval of First Mesenchymal Stromal Cell Therapy for Steroid-Refractory Acute Graft-Versus-Host Disease [Yahoo! Finance]Yahoo! Finance
- How has the FDA approval of Ryoncil affected Mesoblast's stock price? [Yahoo! Finance]Yahoo! Finance