Soligenix, Inc. (SNGX) announced on Monday that its SGX945 or Dusquetide development program for oral lesions of Behçet's Disease has received a 'Fast Track' designation from the FDA.
In the pre-market session, SNGX is at $0.850, up 11.80 percent from the previous close of $0.90 on a volume of 705,076.
The fast-track designation will help the late-stage biopharmaceutical company to submit a new drug application for SGX945 on a rolling basis.
Fast-track designation is intended to facilitate the development and expedite the review of new drugs and biologics intended to treat a serious or life-threatening condition and to address an unmet medical need.
Soligenix said its previous studies with Dusquetide in oral mucositis have clearly validated the biological activity in aphthous ulcers induced by chemotherapy and radiation.
Dusquetide, the active ingredient in SGX945 and SGX942 is said to modulate the body's reaction to both injury and infection towards an anti-inflammatory, anti-infective, and tissue healing response.
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