PolyPid Ltd. (NASDAQ: PYPD) has initiated a New Drug Application submission to the U.S. Food and Drug Administration for D-PLEX₁₀₀, designed to prevent surgical site infections in patients undergoing colorectal surgery.

The Israeli biopharmaceutical company submitted the first modules of the rolling NDA review under the FDA's Fast Track designation. The initial submission includes Chemistry, Manufacturing and Controls and nonclinical sections, with additional components including clinical data expected in the second quarter of 2026.

D-PLEX₁₀₀ utilizes PolyPid's Kynatrix delivery technology to provide prolonged release of the antibiotic doxycycline directly at surgical sites for 30 days. The drug candidate demonstrated a 60% relative risk reduction in surgical site infection incidence in the Phase 3 SHIELD II trial for abdominal colorectal surgery with large incisions.

The FDA previously granted D-PLEX₁₀₀ Breakthrough Therapy Designation for preventing surgical site infections in patients undergoing elective colorectal surgery. The company stated it is advancing discussions for a U.S. commercialization partnership.

"This submission marks a pivotal milestone for PolyPid as we advance D-PLEX₁₀₀ into its regulatory approval phase," said Chief Executive Officer Dikla Czaczkes Akselbrad in a statement.

The information is based on a company press release statement.