India, July 29 -- PolyPid Ltd. (PYPD) said on Wednesday that the U.S. Food and Drug Administration has accepted its New Drug Application for D-PLEX100 and granted the treatment Priority Review for the prevention of surgical site infections in patients undergoing abdominal colorectal surgery.
The FDA set a Prescription Drug User Fee Act (PDUFA) target action date of November 28, 2026, about one quarter earlier than the company's previous expectation, and identified no filing review issues.
The regulatory triggers a $15 million payment from commercial partner Azurity Pharmaceuticals, completing $30 million in upfront and near-term milestone payments under their partnership.
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