Soligenix, Inc. announced that its SGX945 (dusquetide) development program for the treatment of oral lesions of Behçet's Disease has received "Fast Track" designation from the U.S. Food and Drug Administration (FDA). Fast track is a designation that the FDA reserves for a drug intended to treat a serious or life-threatening condition and one that demonstrates the potential to address an unmet medical need for the condition. Fast track designation is intended to facilitate the development and expedite the review of new drugs and biologics.

For instance, should events warrant, Soligenix will be eligible to submit a new drug application (NDA) for SGX945 on a rolling basis, permitting the FDA to review sections of the NDA prior to receiving the complete submission. Additionally, NDAs for fast track development programs ordinarily will be eligible for priority review, which imparts an abbreviated review time of approximately six months.