PolyPid's D-PLEX100 NDA accepted with priority review, PDUFA date set for November 2026
FDA acceptance triggers a $15 million milestone payment from partner Azurity, and PolyPid says review is now on track to finish about three months sooner than expected.
PolyPid Ltd. said on July 29, 2026 that the FDA accepted for filing its New Drug Application for D-PLEX100 and granted it Priority Review. The application covers prevention of surgical site infections in patients undergoing abdominal colorectal surgery.1
The agency did not flag any filing review issues and set a PDUFA target action date of November 28, 2026, moving up from the company's earlier first-quarter 2027 target.1 Priority Review cuts FDA's standard ten-month review timeline down to roughly six months.1
CEO Dikla Czaczkes Akselbrad called the acceptance a milestone and said the company and its commercial partner Azurity are working together as the agency reviews the application, according to the release.
The acceptance also has financial consequences. It triggers a $15 million milestone payment from Azurity Pharmaceuticals, which completes $30 million in upfront and near-term milestone payments tied to the exclusive commercial partnership the two companies signed on July 17, 2026.1
PolyPid said it will continue supporting the FDA's review through the November 28 action date, with Azurity positioned for a possible U.S. launch in early 2027 if the drug is approved.1
On the science, PolyPid described D-PLEX100 as a local, controlled-release antibacterial treatment. After it is placed into the surgical site, the company's Kynatrix delivery technology pairs with active pharmaceutical ingredients to release the antibiotic doxycycline continuously, maintaining a high local drug concentration for about 30 days, with potential activity against antibiotic-resistant bacteria.1 In the Phase 3 SHIELD II trial, the drug met its primary endpoint and showed a 60% relative risk reduction, with a p-value of 0.0013, on a secondary endpoint measuring SSI incidence after abdominal colorectal surgery with large incisions.1 D-PLEX100 previously received Breakthrough Therapy Designation from the FDA for preventing SSIs in elective colorectal surgery patients.1
Written by readthrough’s AI from the linked primary sources and fact-checked against them automatically before publishing. Not investment advice.