PolyPid Submits Marketing Authorization Application for D-PLEX₁₀₀ to EMA
News related to:PolyPid · 2 min read
PETACH TIKVA, Israel, Oct. 01, 2026 /CourierPR/ -- PolyPid, an innovative biopharmaceutical company, has taken a significant step towards commercializing its lead product candidate, D-PLEX₁₀₀, by successfully submitting a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA). The application, submitted on September 14, 2026, is part of the company’s broader strategy to bring D-PLEX₁₀₀ to market in major global markets.
The MAA was submitted under the Centralized Procedure, which is designed for therapeutic innovations. This submission follows productive meetings with the EMA Rapporteur and Co-Rapporteur during the second quarter of 2026. The validation of the MAA by the EMA marks the initiation of a formal regulatory review process, which will be conducted by the Committee for Medicinal Products for Human Use.
D-PLEX₁₀₀ is designed to provide local prolonged and controlled anti-bacterial activity directly at the surgical site, aiming to prevent abdominal surgical site infections (SSIs). The product candidate is supported by PolyPid’s clinical development program, including the positive results from the Phase 3 SHIELD II trial. In this pivotal trial, D-PLEX₁₀₀ met its primary endpoint and demonstrated a 60% relative risk reduction in surgical site infections compared to standard of care (p=0.0013).
The company’s commitment to precision and innovation is evident in the development of D-PLEX₁₀₀. The product is designed to release doxycycline, a broad-spectrum antibiotic, for a period of 30 days following administration into the surgical site. This prolonged release is intended to provide a high local concentration of the drug, which is crucial for preventing SSIs, especially those caused by antibiotic-resistant bacteria.
In addition to the EMA submission, D-PLEX₁₀₀ is also under Priority Review with the U.S. Food and Drug Administration (FDA), with a Prescription Drug User Fee Act (PDUFA) goal date of November 28, 2026. This priority review underscores the significance of the product and the urgency of its potential approval.
PolyPid’s CEO, Dikla Czaczkes Akselbrad, expressed optimism about the progress of D-PLEX₁₀₀.
The company’s pipeline includes other product candidates, and its commitment to elevating treatment effectiveness, right where care begins, is reflected in its diverse portfolio. The positive results from the SHIELD II trial, detailed in PolyPid’s Annual Report on Form 20-F filed on February 25, 2026, further validate the company’s approach and the potential of D-PLEX₁₀₀.
As the company moves forward, it remains focused on maximizing the value of D-PLEX₁₀₀ in the significant European SSI market and exploring strategic possibilities. With the MAA validated and the FDA’s Priority Review in place, PolyPid is well-positioned to bring D-PLEX₁₀₀ to patients in need of effective surgical site infection prevention.