PolyPid regains European commercialization rights for D-PLEX₁₀₀

• PolyPid (NASDAQ:PYPD) regained exclusive European commercialization rights for D-PLEX₁₀₀ after terminating its agreement with ADVANZ PHARMA.
• The company completed its Phase 3 SHIELD II trial and submitted regulatory applications to the FDA and EMA.
• PolyPid believes D-PLEX₁₀₀’s clinical and regulatory progress could attract multinational pharmaceutical partners.

PolyPid (NASDAQ:PYPD) regained exclusive European commercialization rights for D-PLEX₁₀₀ after the company and ADVANZ PHARMA mutually agreed to terminate their 2022 licensing, distribution and supply agreement covering Europe.

The termination returns commercialization rights for the surgical-site infection prevention candidate to PolyPid as the company advances regulatory and partnership opportunities.

PolyPid has completed its Phase 3 SHIELD II clinical trial, submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA), and filed an application with the European Medicines Agency (EMA).

The company reported that D-PLEX₁₀₀ achieved its primary endpoint and all key secondary endpoints in SHIELD II, demonstrating efficacy in preventing surgical site infections.

PolyPid previously established a North American commercialization partnership with Azurity Pharmaceuticals and stated that the combination of clinical results, regulatory submissions and commercialization progress could make D-PLEX₁₀₀ attractive to multinational pharmaceutical companies for Europe and other major markets.