Rigel Pharmaceuticals (RIGL) has announced that the FDA has awarded Orphan Drug status to R289 for the treatment of myelodysplastic syndromes. Prior to this, R289 had also received Fast Track designation for addressing the needs of patients with previously-treated, transfusion-dependent, lower-risk myelodysplastic syndromes.
Rigel's CEO, Raul Rodriguez, stated, "The Orphan Drug and Fast Track designations, combined with promising initial data from our ongoing Phase 1b study in patients with lower-risk MDS, mark essential milestones in progressing R289 as a potential new treatment option."
