Rigel Pharmaceuticals Inc (Nasdaq:RIGL), a commercial stage biotechnology company focused on haematologic disorders and cancer, announced on Thursday that the US Food and Drug Administration (FDA) has granted Orphan Drug designation to R289 for the treatment of myelodysplastic syndromes (MDS).
R289 is a potent and selective dual inhibitor of IRAK1 and IRAK4 currently in Phase 1b clinical development for patients with lower-risk MDS who are relapsed or refractory to prior therapies.
Orphan Drug designation provides Rigel with potential benefits including tax credits, reduced FDA fees and seven years of market exclusivity following potential drug approval. This designation follows the previously granted Fast Track designation for R289 in this patient population.
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