FDAnews
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.