www.fdanews.com/articles/175817-pronai-therapeutics-secures-orphan-drug-status-for-lymphoma-drug
ProNAi Therapeutics Secures Orphan Drug Status for Lymphoma Drug
March 18, 2016
The FDA has awarded ProNAi Therapeutics orphan drug designation for its PNT2258 for treatment of diffuse large B-cell lymphoma.
ProNAi secured European Commission orphan drug status in August 2015 for the same indication.
The company currently is enrolling patients in two Phase 2 trials — “Wolverine,” and “Brighton” — for the treatment of relapsed and refractory DLBCL and Richter’s transformation, respectively.