PYPD - PolyPid pops 24% after D-PLEX100 nabs accelerated review in U.S. for preventing surgical infections

The FDA grants Breakthrough Therapy Designation to PolyPid's (PYPD) lead product candidate D-PLEX100 for the prevention of post-abdominal surgery incisional infection (soft tissue).Breakthrough Therapy status provides for more intensive guidance from the FDA on development, the involvement of more senior agency personnel and a rolling review of the marketing application.The Breakthrough Therapy Designation for D-PLEX100 is based on conclusive positive results from a Phase 2 clinical trial that demonstrated significant decrease in surgical site infections (SSIs) in abdominal surgery with colorectal resection.D-PLEX100 is designed for a prolonged and constant release of the broad-spectrum antibiotic doxycycline, directly at the surgical site to prevent SSIs.Previously in July, PYPD initiated late-stage study of D-PLEX100 for preventing surgical infections.

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PolyPid pops 24% after D-PLEX100 nabs accelerated review in U.S. for preventing surgical infections