PolyPid Ltd. (PYPD) EMA Validates D-PLEX100 MAA; FDA Priority Review Ongoing

Oppenheimer initiated coverage on PolyPid (NASDAQ:PYPD) with an outperform rating and a $10.00 price target. The stock is up 47% over the past year, with a Strong Buy consensus and targets ranging from $8 to $14. PolyPid's D-PLEX100 reduced surgical site infections by 60% in a Phase 3 study and is under FDA Priority Review. The company reported a narrower Q2 2026 loss of $0.35 per share, beating expectations.

PolyPid (NASDAQ: PYPD) announced European Medicines Agency validation of its D-PLEX₁₀₀ Marketing Authorization Application and regained full European commercialization rights. The company's stock rose 15% premarket. D-PLEX₁₀₀, a surgical site infection treatment, has positive Phase 3 data and FDA Priority Review in the U.S. PolyPid aims to partner in Europe on stronger terms than its previous agreement.

PolyPid announced the EMA validated its Marketing Authorization Application for D-PLEX100. The company has regained exclusive EU commercialization rights from ADVANZ Pharma. This follows prior US progress and positive Phase 3 data.

PolyPid's (PYPD) Marketing Authorization Application for D-PLEX₁₀₀, a drug to prevent post-abdominal surgery infections, has been validated by the European Medicines Agency. The application is now under formal review. The FDA is also reviewing D-PLEX₁₀₀ under Priority Review with a PDUFA goal date of November 28, 2026. The drug showed a 60% relative risk reduction in surgical site infections in a Phase 3 trial.

PolyPid Ltd. (Nasdaq: PYPD) has regained exclusive European commercialization rights for D-PLEX₁₀₀ after terminating its agreement with ADVANZ PHARMA. The company plans to explore new partnerships for D-PLEX₁₀₀ in Europe, citing recent milestones like the completion of a Phase 3 trial and FDA/EMO submissions.

PolyPid (PYPD) reported Q2 2026 milestones: FDA accepted its NDA for D-PLEX100 with Priority Review, setting a PDUFA goal date of November 28, 2026. The company also signed a $320M+ commercialization deal with Azurity Pharmaceuticals for the U.S. and Canada, including upfront payments, milestones, and royalties. PolyPid plans to submit an MAA to the EMA in Q3 2026 and expects a U.S. launch in early 2027.