Poolbeg Pharma’s POLB 001 Earns FDA Orphan Drug Status

PUBLISHED: 27 May 2025 @ 18:27 | Comments (0) | More info about Fiona Craig

Poolbeg Pharma (LSE:POLB) has secured Orphan Drug Designation (ODD) from the U.S. Food and Drug Administration for its oral candidate, POLB 001. The therapy targets prevention of Cytokine Release Syndrome (CRS), a serious immune reaction linked to T-cell engager bispecific antibody cancer treatments. This ODD status offers Poolbeg key advantages including potential market exclusivity and tax incentives, boosting the commercial prospects of POLB 001. The company aims to initiate Phase 2a clinical trials by late 2025, with strong interest from major pharmaceutical companies to collaborate on development and support.

About Poolbeg Pharma

Poolbeg Pharma plc is a clinical-stage biotech focused on creating innovative therapies that address significant unmet medical needs. Its pipeline includes treatments for cancer immunotherapy-related CRS and metabolic diseases like obesity, featuring an oral glucagon-like peptide-1 receptor (GLP-1R) agonist designed for improved patient convenience and effectiveness.

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Poolbeg Pharma Launches £4.1 Million Fundraising to Support Clinical Development by Fiona Craig