Benzinga
August 20, 2025 3:33 pm
Fast Track status accelerates regulatory pathway for BioAegis' recombinant human plasma gelsolin (rhu-pGSN), a novel immune modulator for inflammatory diseases.Second Fast Track designation in recent months highlights broad potential of rhu-pGSN across multiple diverse inflammation-driven conditions. NORTH BRUNSWICK, N.J., Aug. 20, 2025 (GLOBE NEWSWIRE) -- BioAegis Therapeutics, a pioneering biotech company at the forefront of innovative therapies for inflammatory diseases, announces that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to its lead product candidate, recombinant human plasma gelsolin (rhu-pGSN), for the treatment of decompression sickness (DCS). The company is currently conducting a Phase 2 study of rhu-pGSN for decompression sickness under a contract awarded by the U.S. Navy's Office of Naval Research to the University of Maryland School of Medicine (UMSOM). This work is the culmination of an extended collaboration with Dr. Stephen Thom, Professor of Emergency Medicine at UMSOM.BioAegis' portfolio is built around plasma gelsolin, a highly conserved and critical immune regulatory protein which rebalances dysfunctional inflammation without suppressing immune function. Fast Track Accelerates Path to Patients for Inflammation-Driven Conditions The FDA Fast Track program is intended to accelerate the development of new therapies for serious conditions with high unmet medical needs. Fast Track status enables more frequent interactions with the FDA, including rolling review of the marketing application, and eligibility for priority review, which can significantly accelerate time to market. For BioAegis, this designation highlights the therapeutic promise of rhu-pGSN and provides a clear regulatory pathway to expedite its development.This marks the second Fast Track designation for BioAegis in recent months following one granted for Acute Respiratory Distress Syndrome (ARDS). These dual designations underscore the breadth and therapeutic potential of rhu-pGSN."Fast Track status is granted for products that are addressing areas of strong unmet need with novel, innovative approaches. Dr. Thom's findings of the ...Full story available on Benzinga.com