ProNAi Therapeutics Granted Orphan Drug Designation for PNT2258 for the Treatment of Diffuse Large B-Cell Lymphoma

ProNAi Therapeutics, Inc. (NASDAQ:DNAI) announced that its oncology drug candidate PNT2258 has been granted Orphan Drug Designation by the U.S. Food and Drug Administration (FDA) for the treatment of diffuse large B-cell lymphoma (DLBCL). This is the second orphan drug designation obtained by ProNAi for PNT2258 for the treatment of DLBCL, following a similar grant by the European Commission in August 2015.
According to the news:

Orphan drug designation is typically granted for novel drugs or biologics that are intended to treat rare medical diseases or conditions that affect less than 200,000 people in the United States. The designation qualifies the sponsor for certain incentives including seven years of market exclusivity after a drug’s approval, tax credits for clinical research costs, and certain application fee waivers.

Dr. Nick Glover, President and CEO of ProNAi stated:

Achieving this regulatory milestone for PNT2258 is an important advancement in our registration-oriented development plan for this cancer drug in DLBCL, a disease for which there are limited treatment options, particularly in patients who relapse or do not respond to front-line therapies.

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