FDAnews Drug Daily Bulletin

Opsona Therapeutics Achieves Orphan Designation for Myelodysplastic Syndrome with OPN-305

Oct. 27, 2016

Dublin-based Opsona Therapeutics has received orphan drug designation from the US FDA for myelodysplastic syndromes.

OPN-305 is a novel proprietary humanized IgG4 monoclonal antibody against Toll-Like Receptor 2, a key target within the innate immune system.

A study in patients with lower-risk MDS who have failed hypomethylating agents is ongoing in collaboration with MD Anderson Cancer Center in Houston.

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