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Poolbeg Pharma PLC on Tuesday announced that it received an orphan drug designation from the US Food & Drug Administration. The London-based clinical stage biopharmaceutical company targeting diseases said the FDA has granted orphan drug designation to its POLB 001 therapy as an oral preventative treatment for T-cell engager bispecific antibody-induced cytokine release syndrome. Poolbeg shares jumped 36% to 3.34 pence each on Tuesday afternoon in London. There are currently no approved preventative therapies for CRS, which is a serious side effect of some cancer immunotherapies, which can cause mild to severe symptoms such as fever, fatigue, chills, dizziness and organ damage. Poolbeg expects the first patient to be dosed in its proposed phase 2a study in the second half of 2025, with interim analysis expected in the first half of 2026 and top-line data in the second half of 2026. Chief Executive Officer Jeremy Skillington said he believes the designation will ‘enhance the commercial appeal for prospective partners and help bring POLB 001 to the market faster’. He continued: ‘If approved, we believe POLB 001 has the potential to improve quality of life for patients, reduce pressure on healthcare systems, and expand access to cancer immunotherapies.’ Copyright 2025 Alliance News Ltd. All Rights Reserved.
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