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) clarified the regulatory pathway for D-PLEX100 to prevent abdominal colorectal surgical site infections following a positive FDA communication. The company plans to resume patient recruitment for the SHIELD II trial in Q2 2023, adding approximately 550 patients, with top-line results anticipated by mid-2024. Financially, R&D expenses decreased to $4.7 million in Q4 2022 from $9.6 million in Q4 2021, while net loss narrowed to $6.5 million, or ($0.32) per share. As of December 31, 2022, cash reserves were $12.6 million, down from $32.2 million in 2021, expected to sustain operations through Q3 2023.
PolyPid Ltd. (Nasdaq: PYPD) announced it will report its fourth quarter and full year 2022 financial results on February 8, 2023, before U.S. market open. The company will conduct a conference call at 8:30 AM ET to discuss these results and business updates. PolyPid is focused on enhancing surgical outcomes through its proprietary PLEX technology, which enables sustained drug delivery. Its lead candidate, D-PLEX100, is currently in Phase 3 trials for preventing surgical site infections, while OncoPLEX is under preclinical evaluation for solid tumors.
PolyPid Ltd. (Nasdaq: PYPD) announced a positive regulatory update for D-PLEX100, targeting the prevention of surgical site infections (SSIs) following abdominal colorectal surgery. Recent communications with the FDA clarified the regulatory pathway for a potential New Drug Application (NDA) submission. The FDA recognized significant findings from the SHIELD I study, noting a 54% reduction in complications in complex surgeries, encouraging a revised SHIELD II trial to support NDA efforts. The company expects to resume patient recruitment soon, enhancing confidence in this promising treatment.
PolyPid Ltd. (Nasdaq: PYPD) announced the publication of a post-hoc analysis from its Phase 2 trial of D-PLEX100, highlighting a significant 53% reduction in surgical site infections (SSIs) compared to standard care in high-risk colorectal surgery patients. The study included 201 patients, showing a 58% risk reduction in those with multiple preoperative risk factors. D-PLEX100 utilizes advanced Polymer-Lipid Encapsulation technology for prolonged antibiotic release, aiming to enhance surgical outcomes. This aligns with findings from the SHIELD I Phase 3 trial, indicating substantial potential for D-PLEX100 in addressing the needs of vulnerable patient populations.
PolyPid Ltd. (Nasdaq: PYPD) has scheduled a Type D meeting with the FDA for January 2023 to discuss the outcomes and regulatory requirements related to its D-PLEX100 product, aimed at preventing abdominal colorectal surgical site infections. The company has submitted existing data from the completed SHIELD I Phase 3 study prior to this meeting. CEO Dikla Czaczkes Akselbrad expressed confidence in D-PLEX100's efficacy, citing significant reductions in infections during complex surgeries.
PolyPid Ltd. (Nasdaq: PYPD) has received a notice from Nasdaq indicating non-compliance with the minimum bid price requirement of $1.00 per share. The company has 180 days until June 5, 2023, to regain compliance. During this grace period, trading of PYPD shares will continue on Nasdaq. If PolyPid fails to meet the requirement, it may be eligible for an additional compliance period, provided it meets other listing standards. The notice does not immediately affect the company’s listing status.
PolyPid Ltd. (Nasdaq: PYPD) announced the presentation of Phase 2 clinical data for D-PLEX100 aimed at preventing surgical wound infections, including those caused by multi-drug resistant organisms. This will occur at the International Orthopaedic Trauma Association meeting from December 14-16, 2022, in Amsterdam. The presentation, titled 'Surgical wound infection reduction with locally administered product releasing doxycycline,' will be delivered by Chief Scientific Officer Noam Emanuel. D-PLEX100 is currently in Phase 3 trials for soft tissue infections.
PolyPid Ltd. (PYPD) announced its corporate update and financial results for Q3 2022, reporting a net loss of $9.3 million, reduced from $9.9 million year-over-year. The company plans to engage with U.S. and EU regulators regarding the D-PLEX100 Phase 3 study outcomes and has noted a 54% reduction in surgical site infections for specific subpopulations. A cost reduction plan, including a 20% workforce cut, aims to extend cash runway into Q3 2023, with available funds reported at $18.1 million.
PolyPid Ltd. (Nasdaq: PYPD) announced it will release its third quarter 2022 financial results and operational updates on November 9, 2022, prior to the U.S. market opening. The company will host a conference call at 8:30 AM ET to discuss these results. PolyPid focuses on enhancing surgical outcomes through its PLEX technology, deploying drug delivery systems that provide controlled release of pharmaceuticals. Its lead candidate, D-PLEX100, is in Phase 3 trials for infection prevention following surgeries.
PolyPid Ltd. (Nasdaq: PYPD) has announced a substantial 20% reduction in headcount as part of a cost-cutting plan aimed at extending its financial runway into Q3 2023. This initiative aligns with their preparations for discussions with U.S. and EU regulatory authorities regarding D-PLEX100 for preventing surgical site infections (SSIs) in abdominal surgeries. Notably, the company received confirmation from the European Medicines Agency for the eligibility of D-PLEX100’s Marketing Authorization Application under the centralized procedure.
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