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.
Alvotech strengthens biosimilar operations with acquisition of Ivers-Lee Group
Adcentrx Therapeutics' ADRX-0405 granted US FDA orphan drug designation
Orsini named KalVista's specialty pharmacy partner for EKTERLY (sebetralstat)
KalVista secures FDA approval for EKTERLY, first oral on-demand HAE treatment
Alcon to acquire LumiThera and its FDA-authorised photobiomodulation device for dry AMD treatment
Akeso's bispecific ADC (Trop2/Nectin4 ADC) enters clinical trials
Biocon Biologics' Denosumab biosimilars receive European Commission approval
Life Molecular Imaging's Neuraceq granted expanded Alzheimer's disease indications by US FDA
European Commission approves Camurus' once-monthly octreotide treatment for acromegaly