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.
NeuroTherapia's Phase 2 Alzheimer's disease trial receives European regulatory approval
Syndax Pharmaceuticals grants share purchase inducement awards to six new employees
Hippo Pharmacy launches fast, free delivery on orders over USD150
Polarean Imaging expands reach with Taiwanese distribution deal
AstraZeneca secures EU recommendation for Imfinzi in limited-stage small cell lung cancer
CHMP recommends EU approval of Daiichi Sankyo and AstraZeneca's datopotamab deruxtecan
Renalys Pharma completes patient enrolment for Phase III clinical trial of sparsentan
NICE recommends ALK's ACARIZAX for house dust mite allergic rhinitis treatment in UK's NHS
Roche's blood test measuring Lp(a) in molar units receives US FDA 510(k) approval
Breckenridge Pharmaceutical's Everolimus Tablets for Oral Suspension receive US FDA approval
Amgen's BLINCYTO (blinatumomab) monotherapy approved in Europe
HeartBeam submits FDA 510(k) application for groundbreaking 12-lead ECG synthesis software
FDA grants Vicore Pharma Fast Track Designation for buloxibutid in idiopathic pulmonary fibrosis
FDA accepts Saol Therapeutics' SL1009 New Drug Application for Priority Review