PolyPid's NDA For D-PLEX100 Receives FDA Priority Review, Stock Up

July 29, 2026 — 10:55 am EDT

Written by RTTNews.com for RTTNews

(RTTNews) - 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.

If approved, D-PLEX100 could be launched in the U.S. by Azurity in early 2027. The treatment previously demonstrated positive Phase 3 results, including a 60 percent relative reduction in surgical site infections, and has received FDA Breakthrough Therapy Designation.

PYPD is currently trading at $4.1300, up $0.38 or 10.13 percent on the Nasdaq.

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PolyPid's NDA For D-PLEX100 Receives FDA Priority Review, Stock Up

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