PolyPid Ltd. (2PV)
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PolyPid Nears FDA Decision for D-PLEX100 After Strong Phase III Data
PolyPid NASDAQ: PYPD is approaching a November 28 PDUFA date for D-PLEX100, its lead product candidate for preventing surgical site infections in patients undergoing colorectal surgery, Chief Executive Officer Dikla Czaczkes Akselbrad said during the Lytham Partners Fall 2026 Investor Conference.
PolyPid Q2 Earnings Call Highlights
PolyPid NASDAQ: PYPD said its second-quarter 2026 was marked by the FDA's acceptance of its new drug application for D-PLEX100 and a commercialization agreement with Azurity Pharmaceuticals covering the United States and Canada.
PolyPid Q1 Earnings Call Highlights
PolyPid NASDAQ: PYPD said its first quarter marked a transition from late-stage clinical development toward regulatory submission and commercial preparation for D-PLEX100, its lead product candidate for preventing surgical site infections in abdominal colorectal surgery.
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PolyPid Ltd. Profile
| Biotechnology Industry | Healthcare Sector | Dikla Czaczkes Akselbrad CEO | XFRA Exchange | IL0011326795 ISIN |
| IL Country | 72 Employees | - Last Dividend | 21 Sep 2023 Last Split | 26 Jun 2020 IPO Date |
Overview
PolyPid Ltd. is a forward-thinking clinical-stage biopharmaceutical company that has dedicated itself to the development of unique, locally administered therapeutics with a prolonged release. The heart of its innovation lies in the proprietary polymer-lipid encapsulation matrix (PLEX) technology, which represents a significant leap forward in addressing various unmet medical needs. Since its establishment in 2008, the company has positioned itself as a leader in its field, operating from its headquarters located in Petah Tikva, Israel. The focus of PolyPid is clear – to bring forth novel therapeutic solutions that can significantly enhance patient outcomes across a range of medical conditions.
Products and Services
D-PLEX100
D-PLEX100 is PolyPid's flagship product candidate, currently advancing through a pivotal Phase 3 confirmatory trial. Its primary use is aimed at the prevention of surgical site infections (SSIs), particularly in patients who are undergoing abdominal colorectal surgery that involves large incisions. This novel therapeutic approach leverages the company’s pioneering PLEX technology to ensure targeted, localized delivery, and prolonged release of the drug, designed to significantly reduce the risk of SSIs post-surgery. The success of D-PLEX100 could redefine standards of care in surgical procedures by drastically lowering infection rates and improving recovery outcomes for patients.
OncoPLEX
OncoPLEX stands as PolyPid’s innovative endeavor into oncology, focusing specifically on the treatment of intra-tumoral cancer. By harnessing the power of PLEX technology, OncoPLEX is being developed to deliver therapeutic agents directly into tumors. This direct approach aims to maximize the effectiveness of cancer treatments by improving drug concentration at the tumor site while minimizing systemic side effects. The development of OncoPLEX underscores PolyPid’s commitment to extending its proprietary technology's benefits beyond infection prevention, offering new hope in the battle against cancer.
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