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Regulatory Pathway for a Potential NDA Submission Clarified Following Recent Interactions with the FDA FDA Acknowledged that SHIELD I Pre-specified Subgroup Results May Provide Supportive Evidence and Proposed that Current SHIELD II Trial Could Potentially Serve to...
D-PLEX100 Achieved in Phase 2 Trial Significant Reduction in SSIs in Patients with Multiple Preoperative Risk Factors Versus Standard of Care Results Consistent with SHIELD I Phase 3 Post-hoc Analysis Demonstrating Significant Primary Endpoint Reduction in Patients...
Meeting Scheduled for January 2023 PolyPid Recently Provided FDA with Currently Available Data from Completed SHIELD I Phase 3 Study in Advance of Meeting PETACH TIKVA, Israel, Dec. 12, 2022 -- PolyPid Ltd. (Nasdaq: PYPD) ("PolyPid" or the "Company"), a late-stage...
PETACH TIKVA, Israel, Dec. 09, 2022 -- PolyPid Ltd. (Nasdaq: PYPD) ("PolyPid" or the "Company"), a late-stage biopharma company aiming to improve surgical outcomes, today announced it has received a written notice (the "Notice") from Nasdaq Stock Market LLC ("Nasdaq")...
D-PLEX Infection Prevention Efficacy in Patients with Increased Risk for Surgical Wound Infections Including Multi-Drug Resistant Organisms (MDROs) will be Presented During a Podium PresentationPETACH TIKVA, Israel, Nov. 29, 2022 -- PolyPid Ltd. (Nasdaq: PYPD)...
Company Intends to Meet with U.S. and EU Regulatory Authorities to Discuss Data from SHIELD I Phase 3 Study and Regulatory Pathway for D-PLEX100 in First Quarter of 2023 Implemented a Cost Reduction Plan, Including a 20% Decrease in Headcount Across All Departments...
PETACH TIKVA, Israel, Oct. 26, 2022 -- PolyPid Ltd. (Nasdaq: PYPD) ("PolyPid" or the "Company"), a late-stage biopharma company aiming to improve surgical outcomes, today announced that it will report its third quarter 2022 financial results and operational highlights...
Reduction of Approximately 20% in Organization Headcount Company Expects to Extend Cash Runway into Q3 2023 PolyPid Intends to Discuss Regulatory Pathway for D-PLEX100 for Prevention of Surgical Site Infections in Abdominal Surgery with U.S. and EU Regulatory...
Intends to discuss the Clinical Outcomes and Next Steps for D-PLEX100 for the Prevention of SSIs in Abdominal Surgery with the FDA and the EU Regulatory Authorities in Q1 2023 PETACH TIKVA, Israel, Sept. 19, 2022 -- PolyPid Ltd. (Nasdaq: PYPD) ("PolyPid" or the...
Efficacy Data of D-PLEX100 in the Prevention of Post-Abdominal Surgery Incisional Infection will be Presented During a Podium Presentation PETACH TIKVA, Israel, Sept. 12, 2022 -- PolyPid Ltd. (Nasdaq: PYPD) ("PolyPid" or the "Company"), a late-stage biopharma company...