Welcome to our dedicated page for Polypid Ltd. news (Ticker: PYPD), a resource for investors and traders seeking the latest updates and insights on Polypid Ltd. stock.
PolyPid Ltd. (Nasdaq: PYPD) is a cutting-edge biopharmaceutical company focused on enhancing surgical outcomes through its innovative drug delivery technology, PLEX™ (Polymer-Lipid Encapsulation matriX). This proprietary technology allows for the precise, prolonged release of drugs directly at the target site, optimizing therapeutic performance and clinical outcomes. PolyPid specializes in the development and manufacturing of products that address unmet medical needs, particularly in the prevention of surgical site infections (SSIs) and treatment of solid tumors.
The company's lead product candidate, D-PLEX100, is designed to provide localized, controlled anti-bacterial activity at surgical sites to prevent SSIs. It is currently undergoing a Phase 3 clinical trial, known as SHIELD II, aimed at preventing infections in patients undergoing open abdominal colorectal surgery. D-PLEX100 has received Breakthrough Therapy Designation from the U.S. Food and Drug Administration, highlighting its potential to address significant medical needs.
PolyPid's product pipeline also includes OncoPLEX, intended for the treatment of solid tumors, beginning with glioblastoma. This product is currently in preclinical stages, showing promising potential in oncology. Additionally, the company's proprietary technology, PLEX™, can encapsulate various drugs, enabling targeted and localized delivery over extended periods, ranging from several days to months.
In terms of recent achievements, PolyPid has successfully enrolled and randomized over 200 patients in its SHIELD II trial, with top-line results expected in the second half of 2024. Moreover, the company recently closed a $16 million private placement financing, which will support ongoing clinical development efforts and extend its cash runway beyond the anticipated interim analysis of the SHIELD II trial.
For more detailed information, visit PolyPid's official website or follow the company on Twitter and LinkedIn.
PolyPid Ltd. (Nasdaq: PYPD) has announced that the European Medicines Agency (EMA) confirmed D-PLEX100 is eligible for a centralized Marketing Authorization Application (MAA). This allows D-PLEX100 to be marketed across all EU member states upon approval. The centralized procedure highlights D-PLEX100 as a potential new option for preventing post-abdominal surgical site infections (SSIs). The company is also evaluating data from its recent Phase 3 SHIELD I trial and plans discussions with regulatory authorities in early 2023.
PolyPid Ltd. (Nasdaq: PYPD) announced positive clinical data from a Phase 2 study of D-PLEX100, aimed at preventing surgical site infections (SSIs) in abdominal surgery. The study showed a 64% relative risk reduction in infection rates, with 8% in the D-PLEX100 group compared to 22% in the control group. Following the results, the company plans to meet with FDA and EU regulatory authorities in Q1 2023 to discuss next steps for D-PLEX100 as it transitions into Phase 3 trials. The product has already received Breakthrough Therapy Designation from the FDA.
PolyPid Ltd. (Nasdaq: PYPD) announced that Phase 2 clinical data for D-PLEX100 will be presented at the European Society for Coloproctology Scientific Conference from September 21-23, 2022, in Dublin, Ireland. The lead candidate D-PLEX100 is designed to prevent surgical site infections through a controlled release of doxycycline for 30 days. The presentation, by Dr. Anthony J. Senagore, aims to highlight the product's potential in improving surgical outcomes.
PolyPid Ltd. announced top-line results from its SHIELD I Phase 3 study of D-PLEX100 for preventing surgical site infections (SSIs) in abdominal surgery. The trial did not achieve its primary endpoint of reducing SSIs and mortality overall, with a 23% reduction in SSIs (p=0.1520). However, a subgroup analysis of patients with incision lengths over 20 cm showed a significant 54% reduction in SSIs (p<0.0032). The independent Data Safety Monitoring Board found no safety concerns. PolyPid plans to discuss results with the FDA and further assess next steps.
PolyPid Ltd. (Nasdaq: PYPD) announced the presentation of Phase 2 clinical and animal study data for D-PLEX100 at the 2022 Military Health System Research Symposium from September 12-15, 2022. The podium presentation will address D-PLEX100's efficacy in reducing surgical site infection rates and drug-resistant bacteria in surgical trauma injuries. This presentation will be led by Noam Emanuel, PhD, Co-Founder and Chief Scientific Officer. D-PLEX100 is currently in Phase 3 trials aimed at preventing surgical site infections.
PolyPid Ltd. (Nasdaq: PYPD) announced an exclusive licensing agreement with ADVANZ PHARMA for D-PLEX100, targeting over $110 million in upfront and milestone payments, plus potential royalties. The agreement aims to commercialize D-PLEX100 for preventing surgical site infections in Europe. The independent Data Safety Monitoring Board recommended concluding the Phase 3 SHIELD I trial after 950 patient enrollments. Top-line results are expected by the end of Q3 2022, with potential NDA submission in 2023. For Q2 2022, the company reported a loss of $11.8 million, increasing R&D expenses to $8.4 million.
PolyPid Ltd. (Nasdaq: PYPD) has partnered with ADVANZ PHARMA to commercialize D-PLEX100 in Europe for preventing surgical site infections (SSIs) in abdominal and cardiac surgeries. The agreement offers PolyPid an upfront payment of $2.6 million and a total of up to $23.5 million in developmental milestones. Additionally, PolyPid anticipates up to $89 million in sales-related milestones and royalties on net sales. This collaboration leverages ADVANZ PHARMA's expertise and resources to enhance access to this vital therapy, pending approval.
PolyPid Ltd. (Nasdaq: PYPD) announced the upcoming release of its Q2 2022 financial results and operational highlights on August 10, 2022, before U.S. market open. A conference call is set for 8:30 a.m. Eastern Time to discuss the results and business updates. PolyPid is a late-stage biopharma company focused on improving surgical outcomes, leveraging its PLEX technology for drug delivery. Their lead candidate, D-PLEX100, is in Phase 3 trials targeting surgical site infections.
PolyPid Ltd. (Nasdaq: PYPD) announced that Phase 2 clinical data for its lead product candidate D-PLEX100 will be presented at the Midwest Surgical Association 2022 Annual Meeting on August 8, 2022. This podium presentation, titled Reduction in Surgical Site Infections by Localized Administration with D-PLEX100 in Patients with Multiple Risk Factors Undergoing Colorectal Surgery, will be given by Senior Medical Director Dr. Anthony J. Senagore. D-PLEX100 aims to prevent infections post-abdominal surgery.
PolyPid Ltd. (Nasdaq: PYPD) has announced the appointment of Dikla Czaczkes Akselbrad as the new CEO, effective July 1, 2022. Formerly the Executive Vice President and CFO, Akselbrad brings over 20 years of experience in life sciences. Her leadership is expected to be vital as the company prepares for a potential New Drug Application submission and the commercialization of D-PLEX100. The company recently completed its SHIELD I Phase 3 study, with top-line results anticipated by the end of the current quarter.
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