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) announced a webinar on June 23, 2022, featuring key opinion leaders discussing the costs of managing surgical site infections (SSIs). Presentations will include insights from Dr. Kyle Cologne and Dr. Elliot Goodman. The company's leadership will also provide an update on the SHIELD I Phase 3 clinical trial for D-PLEX100, aimed at preventing SSIs in abdominal surgery. This marks a significant milestone following the completion of patient enrollment. Interested participants can register for the event online.
PolyPid Ltd. (Nasdaq: PYPD) announced that data from its Phase 2 clinical trial of D-PLEX100 for preventing surgical site infections in elective colorectal surgery will be presented at the ASM Microbe 2022 conference on June 9-13, 2022. The study evaluates D-PLEX100 alongside standard infection prophylaxis. Dr. Judith Steenbergen will present findings on the impact of the doxycycline-eluting formulation. PolyPid's D-PLEX100 is a lead candidate in Phase 3 trials, targeting soft tissue infections.
PolyPid Ltd. (Nasdaq: PYPD), a late-stage biopharma company, will present at the JMP Securities 2022 Life Sciences Conference in New York City on June 15-16, 2022. The presentation is scheduled for June 15 at 11:00 AM Eastern Time. PolyPid focuses on improving surgical outcomes through its proprietary PLEX technology, which allows controlled, prolonged release of therapeutics. The lead product candidate, D-PLEX100, is currently in Phase 3 trials targeting surgical site infections. For inquiries, investors can reach out to their JMP representatives.
PolyPid Ltd. (Nasdaq: PYPD) announced promising animal study results regarding its lead product candidate, OncoPLEX, presented at the ASCO 2022 Annual Meeting. The studies indicate that locally administered OncoPLEX, which employs the PLEX technology for extended release of docetaxel, significantly reduces local tumor recurrence compared to systemic chemotherapy. In the CT26 model, 75% of OncoPLEX-treated animals were tumor-free versus 25% for the control. Similarly, 80% of U-87 model animals treated with OncoPLEX were tumor-free compared to 30% with the control. The Company plans to initiate a Phase 1/2 study.
PolyPid Ltd. (PYPD) announced the completion of patient enrollment in the SHIELD I Phase 3 study of D-PLEX100, aimed at preventing surgical site infections (SSIs) in abdominal surgery. Following an unblinded interim efficacy analysis, the Data Safety Monitoring Board recommended closing the study at 950 patients, the minimum target. Top-line results are expected by the end of Q3 2022, with potential NDA and MAA submissions planned for H1 2023, following a pre-NDA meeting with the FDA. This pivotal trial represents a significant milestone in PolyPid's development efforts.
PolyPid Ltd. (PYPD) announced the expected enrollment of its 950th patient in the SHIELD I Phase 3 study of D-PLEX100 for preventing surgical site infections (SSIs) in abdominal surgeries. The independent Data Safety Monitoring Board recommended concluding enrollment after reviewing data from 750 patients. Top-line results are anticipated by Q3 2022, with potential NDA and MAA submissions targeted for H1 2023. SSIs pose a significant healthcare burden, costing the U.S. nearly $10 billion annually. Successful results could significantly impact surgical outcomes and market opportunities.
PolyPid Ltd. (PYPD) announced significant updates regarding its Phase 3 SHIELD I trial of D-PLEX100, with approximately 900 patients enrolled. An unblinded interim analysis is expected soon, which could lead to early trial adjustments. The company secured a $15 million non-dilutive term loan to enhance cash flow and support commercialization efforts for D-PLEX100. Financial results show a loss of $11.9 million for Q1 2022, up from $8.7 million year-over-year, as R&D expenses increased. Cash reserves are sufficient to sustain operations into Q2 2023.
PolyPid Ltd. (Nasdaq: PYPD) announced it will release its first quarter 2022 financial results on May 11, 2022, before U.S. market opening.
A conference call and webcast will follow at 8:30 AM ET to discuss the results and operational highlights.
PolyPid focuses on improving surgical outcomes with its proprietary PLEX technology, currently advancing its lead product D-PLEX100 in Phase 3 trials for preventing surgical site infections.
PolyPid Ltd. (Nasdaq: PYPD) announced the presentation of clinical data at the 13th European and Global CLINAM Summit for Nanomedicine, focusing on D-PLEX100. The study demonstrated D-PLEX100 as an effective surgical site infection prevention agent in colorectal surgery patients, limiting antimicrobial resistance (AMR) without increasing postoperative colonization by multi-drug resistant organisms. This emphasizes the potential of PolyPid's proprietary PLEX technology in enhancing surgical outcomes. The presentation will be accessible on their website after the summit.
PolyPid Ltd. (Nasdaq: PYPD) announced plans to present clinical data evaluating the addition of D-PLEX100 to standard infection prophylaxis in elective colorectal surgery. This presentation will occur at the Surgical Infection Society 2022 Annual Meeting on April 23-26, 2022. The study titled ‘Incisional microenvironments and reduction in SSIs in patients treated with a local doxycycline-eluting formulation’ will be led by Dr. Anthony Senagore. PolyPid aims to enhance surgical outcomes through its proprietary PLEX technology, with D-PLEX100 currently in Phase 3 trials.
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