PolyPid Ltd.
No SEC Form 4 filings for $PYPD in the last 30 days.
See all $PYPD insider activity →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.
Over the past 7 days, AlphAI's AI scored 2 news stories mentioning PYPD (PolyPid Ltd.). Coverage has skewed bullish: 2 bullish, 0 neutral, and 0 bearish.
Recent PYPD coverage spans regulation, financial news and earnings.
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.
Regulatory validation likely lifts the stock as the product moves closer to EU approval.
Regaining rights could boost European sales potential and improve valuation.
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.
Regulatory acceptance with Priority Review and a funded commercialization deal materially de-risks timing and funding into key milestones, supporting a bullish risk/reward skew.
AlphAI scores every news story that mentions PYPD with an AI model for sentiment and relevance, and aggregates insider trades from PolyPid Ltd.'s SEC EDGAR Form 4 filings. Figures refresh continuously.
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.
1 min readPolyPid'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.
2 min readPolyPid 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.
2 min readPolyPid (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.
3 min readPolyPid 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.
6 min readPolyPid 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.
7 min readPolyPid 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
2 min readPolyPid (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.
2 min readPolyPid Ltd. (PYPD) said it signed an exclusive commercialization deal with Azurity Pharmaceuticals for D-PLEX100 to prevent abdominal surgical site infections in the U.S. and Canada. PolyPid gets $15M upfront, $15M on FDA NDA acceptance, and up to $300M in milestones. Deal follows Phase 3 SHIELD II results; U.S. launch targeted Q1 2027. Analysts at Roth and H.C. Wainwright set Buy ratings and $9 and $13 targets.
7 min readPETACH TIKVA, Israel, Sept. 30, 2025 ( GLOBE NEWSWIRE ) -- PolyPid Ltd. ( NASDAQ:PYPD ) ( "PolyPid" or the "Company" ) , a late-stage biopharma company aiming to improve surgical outcomes, today announced that Dr. Shmuel Sharoni will present the topline results from the Company's successful ...
2 min read
