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PolyPid Shares Surge After FDA Grants Priority Review to D-PLEX100
Shares of PolyPid Ltd. (NASDAQ:PYPD) surged Wednesday after the U.S. Food and Drug Administration (FDA) accepted the company's New Drug Application (NDA) for D-PLEX100. The agency also granted the application Priority Review, a designation that shortens the target review timeline from ten to approximately six months.
Regulatory and Market Impact
The FDA has set a Prescription Drug User Fee Act (PDUFA) target action date of November 28, 2026, for its decision on D-PLEX100. This is approximately one quarter ahead of the company's previously communicated guidance of the first quarter of 2027. According to Investing.com, the agency identified no filing review issues.
Following the news, PolyPid's shares rose 11.2% in Wednesday trading. The accelerated timeline could allow the company and its commercial partner to bring the product to market sooner than anticipated, if approved.
Financial and Commercial Milestones
The NDA acceptance triggers a $15 million milestone payment to PolyPid from its commercial partner, Azurity Pharmaceuticals. This payment completes the $30 million in upfront and near-term milestone payments outlined in the exclusive commercial partnership signed on July 17, 2026.
AdPending FDA approval, PolyPid and Azurity are preparing for a potential U.S. commercial launch in early 2027. D-PLEX100 is intended for the prevention of surgical site infections in patients undergoing abdominal colorectal surgery.
About D-PLEX100
D-PLEX100 is an investigational drug candidate that uses PolyPid's proprietary delivery technology to provide a prolonged and controlled local release of the broad-spectrum antibiotic doxycycline for up to 30 days directly at the surgical site.
In its Phase 3 SHIELD II clinical trial, D-PLEX100 met its primary endpoint. The trial also demonstrated a 60% relative risk reduction in the incidence of surgical site infections as a secondary endpoint. The drug previously received Breakthrough Therapy Designation from the FDA for this indication.
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