#POLB Poolbeg Pharma PLC – FDA Orphan Drug Designation granted for POLB 001 & AGM May 27, 2025 – Posted in: Poolbeg Pharma (POLB)

27 May 2025 – Poolbeg Pharma (AIM: POLB, ‘Poolbeg’ or the ‘Company’), a clinical-stage biopharmaceutical company focussed on the development of innovative medicines to address unmet medical needs, announces that the US Food and Drug Administration (“FDA”) has granted Orphan Drug Designation (“ODD”) to POLB 001 as an oral preventative therapy for T-cell engager bispecific antibody-induced Cytokine Release Syndrome (“CRS”).   The FDA grants orphan status to support the development of medicines for rare disorders affecting less than…