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NEWS
Rigel Announces R289 Granted Fast Track Designation by the FDA for Lower-Risk MDS
Rigel Pharmaceuticals (Nasdaq: RIGL) announced that the FDA has granted Fast Track designation to R289 for treating patients with previously-treated transfusion dependent lower-risk myelodysplastic syndrome (LR-MDS). R289, a dual inhibitor of IRAK1 and IRAK4, is currently being evaluated in a Phase 1b study. The Fast Track designation may provide benefits including more frequent FDA interactions and eligibility for Accelerated Approval and Priority Review. The drug works by blocking inflammatory cytokine production in response to toll-like receptor and interleukin-1 receptor family signaling, targeting the pro-inflammatory environment in bone marrow responsible for persistent cytopenias in lower-risk MDS patients.
Rigel Pharmaceuticals (Nasdaq: RIGL) announced that the FDA has granted Fast Track designation to R289 for treating patients with previously-treated transfusion dependent lower-risk myelodysplastic syndrome (LR-MDS). R289, a dual inhibitor of IRAK1 and IRAK4, is currently being evaluated in a Phase 1b study. The Fast Track designation may provide benefits including more frequent FDA interactions and eligibility for Accelerated Approval and Priority Review. The drug works by blocking inflammatory cytokine production in response to toll-like receptor and interleukin-1 receptor family signaling, targeting the pro-inflammatory environment in bone marrow responsible for persistent cytopenias in lower-risk MDS patients.
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