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Mesoblast LimitedASX: MSB

FDA Accepts BLA for RYONCIL and Agrees to Priority Review

Mar 31, 2020 at 9:47 PM EDT · Issued by Mesoblast Limited

Filed with ASX · Mar 31, 2020 at 9:47 PM EDT

On 6ix: 6ix.com/news/fda-accepts-bla-for-ryoncil-and-agrees-to-priority-review

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Story so far

  • Mesoblast Submits Completed BLA for Ryoncil to US FDAFeb 3, 2020

Earlier from Mesoblast

  • Mesoblast to Evaluate Remestemcel-L in COVID-19 Lung DiseaseMar 9, 2020
  • Mesoblast Provides Half Year Results and Corporate UpdateFeb 26, 2020
  • Mesoblast Submits Completed BLA for Ryoncil to US FDAFeb 2, 2020
  • Appendix 4C - quarterlyJan 28, 2020
  • MSB Files GvHD Clinical Efficacy and Safety Data with US FDAJan 1, 2020

Later from Mesoblast

  • FDA Clears IND for Remestemcel Use in COVID-19 ARDS PatientsApr 5, 2020
  • US NIH Trials Network to Conduct COVID-19 Phase 2/3 TrialApr 8, 2020
  • 83% Survival in COVID-19 ARDS Patients with Remestemcel-LApr 24, 2020
  • Phase 2/3 Trial in COVID-19 ARDS Begins EnrollmentApr 29, 2020
  • MSB Completes Financing For Covid-19 ARDS ManufacturingMay 13, 2020
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