Latest news with #PolyPidLtd
Yahoo
09-06-2025
- Business
- Yahoo
Nano-Cap PolyPid's Lead Drug Candidate Cuts Surgical Infection Risk by 38% In Phase 3 Trial
PolyPid Ltd. (NASDAQ:PYPD) on Monday announced topline results from its pivotal SHIELD II Phase 3 trial of D-PLEX100 to prevent surgical site infections (SSIs) in patients undergoing abdominal colorectal surgery with large incisions. The SHIELD II trial is designed to assess the efficacy and safety of D-PLEX100 administered concomitantly with the standard of care (SoC), which includes prophylactic systemic antibiotics, compared to the SoC alone arm in the prevention of post-abdominal-surgery incisional infection in patients undergoing abdominal colorectal surgeries with large incisions. The trial's primary endpoint is measured by the proportion of subjects with a surgical site infection or mortality for any reason within 30 days post-surgery. FDA Pushes Pause On Axsome Fibromyalgia Drug, New Trial Required Patient safety will be monitored for an additional 30 days. The trial will enroll patients in centers in the United States, Europe, and Israel. D-PLEX100, PolyPid's lead product candidate, is designed to provide local, prolonged, and controlled antibacterial activity directly at the surgical site to prevent SSIs. Following the administration of D-PLEX100 into the surgical site, the PLEX (Polymer-Lipid Encapsulation matriX) technology pairs with Active Pharmaceutical Ingredients, enabling a prolonged and continuous release of the broad-spectrum antibiotic doxycycline, resulting in a high local concentration of the drug for 30 days for the prevention of SSIs, with additional potential to prevent SSIs caused by antibiotic-resistant bacteria at the surgical site. The trial met the primary efficacy endpoint, with a significantly lower proportion of primary endpoint events among patients who received D-PLEX100 plus SoC (n=405; 10.9%), compared to SoC alone (n=393; 18.1%), representing a 38% reduction (p<0.005). SHIELD II included three key secondary endpoints: The first key secondary endpoint was met, with a 58% reduction in deep and superficial SSI rates among patients who received D-PLEX100 plus SoC (3.8%) compared to those who received SoC alone (9.5%) (p<0.005). The second key secondary endpoint showed statistical significance in favor of D-PLEX100 plus SoC over SoC alone (p<0.005). The third key secondary endpoint was met with a 62% reduction of patients with an ASEPSIS1 score >20 in the D-PLEX100 plus SoC arm compared to the SoC alone arm (p<0.05). The ASEPSIS score is a clinical tool used to assess surgical wound infections objectively. The independent Data Safety Monitoring Board raised no safety concerns in SHIELD II. The company expects to submit a New Drug Application to the U.S. Food and Drug Administration in early 2026, with a Marketing Authorization Application in the E.U. to follow shortly thereafter. Price Action: PYPD stock is trading higher by 12% to $3.66 at last check Monday. Read Next:Photo by ittawit21 via Shutterstock Up Next: Transform your trading with Benzinga Edge's one-of-a-kind market trade ideas and tools. Click now to access unique insights that can set you ahead in today's competitive market. Get the latest stock analysis from Benzinga? This article Nano-Cap PolyPid's Lead Drug Candidate Cuts Surgical Infection Risk by 38% In Phase 3 Trial originally appeared on © 2025 Benzinga does not provide investment advice. All rights reserved.
Yahoo
06-06-2025
- Business
- Yahoo
PolyPid to Host Conference Call and Webcast to Discuss D-PLEX₁₀₀ SHIELD II Phase 3 Trial Topline Results on Monday, June 9, 2025
PETACH TIKVA, Israel, June 06, 2025 (GLOBE NEWSWIRE) -- PolyPid Ltd. (Nasdaq: PYPD), ('PolyPid' or the 'Company'), a late-stage biopharma company aiming to improve surgical outcomes, today announced that it will host a conference call and webcast to report topline data for the SHIELD II Phase 3 trial, evaluating D-PLEX100 for the prevention of surgical site infections in patients undergoing abdominal colorectal surgery, on Monday, June 9, at 8:30 a.m. ET. To ensure you are connected prior to the beginning of the call, PolyPid suggests registering a minimum of 5 minutes before the start of the call. Conference Call Dial-In & Webcast Information: Date: Monday, June 9, 2025 Time: 8:30 AM Eastern Time Conference Call: Webcast: About PolyPid PolyPid Ltd. (Nasdaq: PYPD) is a late-stage biopharma company aiming to improve surgical outcomes. Through locally administered, controlled, prolonged-release therapeutics, PolyPid's proprietary PLEX (Polymer-Lipid Encapsulation matriX) technology pairs with Active Pharmaceutical Ingredients (APIs), enabling precise delivery of drugs at optimal release rates over durations ranging from several days to months. PolyPid's lead product candidate D-PLEX100 is in Phase 3 clinical trial for the prevention of abdominal colorectal surgical site infections. In addition, the Company is currently in preclinical stages to test the efficacy of OncoPLEX for the treatment of solid tumors, beginning with glioblastoma. For additional Company information, please visit and follow us on Twitter and LinkedIn. Contacts:PolyPid Ltd. Ori WarshavskyCOO – US908-858-5995IR@ Investors:Brian RitchieLifeSci Advisors212-915-2578britchie@ in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Yahoo
06-06-2025
- Business
- Yahoo
PolyPid to Host Conference Call and Webcast to Discuss D-PLEX₁₀₀ SHIELD II Phase 3 Trial Topline Results on Monday, June 9, 2025
PETACH TIKVA, Israel, June 06, 2025 (GLOBE NEWSWIRE) -- PolyPid Ltd. (Nasdaq: PYPD), ('PolyPid' or the 'Company'), a late-stage biopharma company aiming to improve surgical outcomes, today announced that it will host a conference call and webcast to report topline data for the SHIELD II Phase 3 trial, evaluating D-PLEX100 for the prevention of surgical site infections in patients undergoing abdominal colorectal surgery, on Monday, June 9, at 8:30 a.m. ET. To ensure you are connected prior to the beginning of the call, PolyPid suggests registering a minimum of 5 minutes before the start of the call. Conference Call Dial-In & Webcast Information: Date: Monday, June 9, 2025 Time: 8:30 AM Eastern Time Conference Call: Webcast: About PolyPid PolyPid Ltd. (Nasdaq: PYPD) is a late-stage biopharma company aiming to improve surgical outcomes. Through locally administered, controlled, prolonged-release therapeutics, PolyPid's proprietary PLEX (Polymer-Lipid Encapsulation matriX) technology pairs with Active Pharmaceutical Ingredients (APIs), enabling precise delivery of drugs at optimal release rates over durations ranging from several days to months. PolyPid's lead product candidate D-PLEX100 is in Phase 3 clinical trial for the prevention of abdominal colorectal surgical site infections. In addition, the Company is currently in preclinical stages to test the efficacy of OncoPLEX for the treatment of solid tumors, beginning with glioblastoma. For additional Company information, please visit and follow us on Twitter and LinkedIn. Contacts:PolyPid Ltd. Ori WarshavskyCOO – US908-858-5995IR@ Investors:Brian RitchieLifeSci Advisors212-915-2578britchie@
Yahoo
06-06-2025
- Business
- Yahoo
PolyPid to Host Conference Call and Webcast to Discuss D-PLEX₁₀₀ SHIELD II Phase 3 Trial Topline Results on Monday, June 9, 2025
PETACH TIKVA, Israel, June 06, 2025 (GLOBE NEWSWIRE) -- PolyPid Ltd. (Nasdaq: PYPD), ('PolyPid' or the 'Company'), a late-stage biopharma company aiming to improve surgical outcomes, today announced that it will host a conference call and webcast to report topline data for the SHIELD II Phase 3 trial, evaluating D-PLEX100 for the prevention of surgical site infections in patients undergoing abdominal colorectal surgery, on Monday, June 9, at 8:30 a.m. ET. To ensure you are connected prior to the beginning of the call, PolyPid suggests registering a minimum of 5 minutes before the start of the call. Conference Call Dial-In & Webcast Information: Date: Monday, June 9, 2025 Time: 8:30 AM Eastern Time Conference Call: Webcast: About PolyPid PolyPid Ltd. (Nasdaq: PYPD) is a late-stage biopharma company aiming to improve surgical outcomes. Through locally administered, controlled, prolonged-release therapeutics, PolyPid's proprietary PLEX (Polymer-Lipid Encapsulation matriX) technology pairs with Active Pharmaceutical Ingredients (APIs), enabling precise delivery of drugs at optimal release rates over durations ranging from several days to months. PolyPid's lead product candidate D-PLEX100 is in Phase 3 clinical trial for the prevention of abdominal colorectal surgical site infections. In addition, the Company is currently in preclinical stages to test the efficacy of OncoPLEX for the treatment of solid tumors, beginning with glioblastoma. For additional Company information, please visit and follow us on Twitter and LinkedIn. Contacts:PolyPid Ltd. Ori WarshavskyCOO – US908-858-5995IR@ Investors:Brian RitchieLifeSci Advisors212-915-2578britchie@ in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Yahoo
03-03-2025
- Business
- Yahoo
PolyPid to Participate in the 37th Annual ROTH Conference
PETACH TIKVA, Israel, March 03, 2025 (GLOBE NEWSWIRE) -- PolyPid Ltd. (Nasdaq: PYPD), ('PolyPid' or the 'Company'), a late-stage biopharma company aiming to improve surgical outcomes, today announced that the Company's management will present at the 37th Annual ROTH Conference taking place in Dana Point, California, from March 17-18, 2025. PolyPid's fireside chat will be available on-demand beginning on Monday, March 17, 2025, at 2:00 PM PT via the conference platform using the following link. The PolyPid management team will participate in one-on-one investor meetings during this event. Investors interested in meeting with PolyPid around the conference should contact their ROTH representative. About PolyPid PolyPid Ltd. (Nasdaq: PYPD) is a late-stage biopharma company aiming to improve surgical outcomes. Through locally administered, controlled, prolonged-release therapeutics, PolyPid's proprietary PLEX (Polymer-Lipid Encapsulation matriX) technology pairs with Active Pharmaceutical Ingredients (APIs), enabling precise delivery of drugs at optimal release rates over durations ranging from several days to months. PolyPid's lead product candidate D-PLEX100 is in Phase 3 clinical trial for the prevention of abdominal colorectal surgical site infections. In addition, the Company is currently in preclinical stages to test the efficacy of OncoPLEX for the treatment of solid tumors, beginning with glioblastoma. For additional Company information, please visit and follow us on Twitter and LinkedIn. Contacts: PolyPid Ltd. Ori Warshavsky COO – US 908-858-5995 IR@ Investors: Brian Ritchie LifeSci Advisors 212-915-2578 britchie@ in to access your portfolio
