PolyPid Ltd.
- Market Cap (Float-Adj) (Float-adjusted market cap computed by the low-float screener — matches the screener row. May differ from the standard cap (price × all shares outstanding) reported elsewhere.)
- $107.0M
- Price
- $5.13
- % Change (Daily % change from the live per-ticker quote feed.)
- -1.35%
- Volume
- 86.6K
About
PolyPid Ltd. is an advanced-stage biopharmaceutical company specializing in the development, manufacturing, and commercialization of therapeutic solutions. These solutions are based on its proprietary polymer-lipid encapsulation matrix (PLEX) platform, with the goal of addressing significant unmet medical needs. The company's leading product candidate, D-PLEX100, is currently undergoing Phase III clinical trials. It is being evaluated for its efficacy in preventing surgical site infections (SSIs) following both sternal (bone) and abdominal (soft tissue) procedures. Established in 2008, PolyPid Ltd. is headquartered in Petah Tikva, Israel.
Quick stats
Shares outstanding20.9M
Computed float15.5M
Float / shares74.4%
Cash runway (months)7.1
Key info
SectorHealthcare
IndustryBiotechnology
CIK (Central Index Key — the unique ID the SEC assigns to every filer. Use it to look up the company's filings on EDGAR.)0001611842
Websitehttps://www.polypid.com
AI Summary
AI-generated1/18
standardbullishregulatory
European Medicines Agency Validates PolyPid’s Marketing Authorization Application for D-PLEX₁₀₀
The EMA has validated PolyPid's Marketing Authorization Application for D-PLEX100, its lead candidate for preventing post-abdominal-surgery incisional infections, initiating formal review under the Centralized Procedure.
The application, submitted September 14, 2026, is supported by the positive pivotal Phase 3 SHIELD II trial, which showed a 60% relative risk reduction in surgical site infections versus standard of care (p=0.0013).
In parallel, the FDA is reviewing the D-PLEX100 NDA under Priority Review with a PDUFA goal date of November 28, 2026, and PolyPid retains ex-U.S./Canada rights where it is exploring strategic options for the European market.
Red flags
- Regulatory approvals remain pending; EMA validation confirms completeness, not likelihood of approval
- Binary PDUFA event on November 28, 2026 is a significant catalyst risk