$PYPD

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 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 Ltd. announced that the EMA validated its Marketing Authorization Application for D-PLEX100, starting a formal review. The FDA is also reviewing its NDA under Priority Review with a PDUFA date of Nov. 28, 2026, following positive Phase 3 results.

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.

PolyPid said the FDA accepted its D-PLEX100 NDA with Priority Review and no filing issues, targeting a PDUFA date of Nov. 28, 2026. It signed an exclusive U.S. and Canada commercialization deal with Azurity, including upfront and tiered royalties plus a transfer price for retained manufacturing units. PolyPid expects a U.S. launch in early 2027 and $30M in milestone payments.

PolyPid Ltd. (Nasdaq: PYPD) said the FDA accepted its D-PLEX100 NDA for priority review for preventing surgical site infections in abdominal colorectal surgery, with a PDUFA goal date of Nov. 28, 2026. PolyPid entered an exclusive U.S. and Canada commercialization partnership with Azurity, receiving $30 million upfront and near-term milestones, plus tiered mid-teen to mid-twenties royalties. Q2 2026 net loss was $7.8M.

PolyPid Ltd. (PYPD) furnished an SEC Form 6-K — earnings release. Exhibit 99.1 PolyPid Provides Corporate Update and Reports Second Quarter 2026 Financial Results FDA Accepted D-PLEX₁₀₀ NDA with Priority Review; PDUFA Goal Date of November 28, 2026, Approximately One Quarter Ahead of Previously Communicated Guidance Exclusive U.S. and Canada Co

PolyPid (Nasdaq: PYPD) said the FDA accepted its NDA for D-PLEX100 to prevent surgical site infections in abdominal colorectal surgery and granted Priority Review. The PDUFA target action date is Nov. 28, 2026. FDA found no filing review issues. Acceptance triggers a $15 million milestone from Azurity, completing $30 million in upfront and near-term milestones.