PolyPid Ltd. (PYPD), a clinical-stage biopharmaceutical company, announced that it has submitted a New Drug Application to the U.S. Food and Drug Administration or NDA for its lead investigational candidate D-PLEX100 to prevent surgical site infections in patients undergoing colorectal surgery.
The NDA for D-PLEX100 was submitted based on positive results from the Phase 3 trial dubbed SHIELD II.
D-PLEX100 is investigational and is designed to prevent surgical site infections following abdominal colorectal surgery. It uses PolyPid's proprietary Kynatrix technology to deliver doxycycline locally at the surgical site for approximately 30 days.
In the Phase 3 results, D-PLEX100 met its primary endpoint and all key secondary endpoints, demonstrating a 60% relative reduction in surgical site infections (SSIs) compared with the standard of care.
Additionally, the FDA has granted D-PLEX100 Breakthrough Therapy, Fast Track, and Qualified Infectious Disease Product designations, which the company believes may support eligibility for priority review.
The FDA decision on D-PLEX100 is expected in the first quarter of 2027 under the Prescription Drug User Fee Act review timeline.
PYPD has traded between $2.77 and $5.20 over the last year.
PYPD is currently trading at $5.16, up 1.68%.
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