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Poolbeg Pharma’s POLB 001 Receives FDA Orphan Drug Designation

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Poolbeg Pharma’s POLB 001 Receives FDA Orphan Drug Designation

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Poolbeg Pharma Ltd. ( (GB:POLB) ) has provided an announcement.

Poolbeg Pharma has received Orphan Drug Designation (ODD) from the FDA for its oral therapy POLB 001, aimed at preventing T-cell engager bispecific antibody-induced Cytokine Release Syndrome (CRS), a severe side effect of cancer immunotherapy. This designation provides Poolbeg with benefits such as potential market exclusivity and tax credits, enhancing POLB 001’s commercial appeal and industry interest. The company plans to begin Phase 2a trials in late 2025, with significant interest from Big Pharma to support these trials, indicating strong potential for future partnerships.

More about Poolbeg Pharma Ltd.

Poolbeg Pharma plc is a clinical-stage biopharmaceutical company focused on developing innovative medicines to address unmet medical needs. The company’s clinical programs target large addressable markets, including cancer immunotherapy-induced Cytokine Release Syndrome (CRS) and metabolic conditions such as obesity, with the development of an oral encapsulated glucagon-like peptide GLP-1R agonist.

Average Trading Volume: 1,003,463

Technical Sentiment Signal: Sell

For a thorough assessment of POLB stock, go to TipRanks’ Stock Analysis page.

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