25 August 2025 - Ayrmid today announced that the US FDA has accepted the Company’s priority review application for omidubicel for the treatment of severe aplastic anaemia and has assigned a PDUFA target action date of 10 December 2025. 

The supplementary biologics license application submission is based on results of an investigator sponsored study at the National Heart, Lung, and Blood Institute of the National Institutes of Health.

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