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. (PYPD) announced significant recruitment progress in its Phase 3 SHIELD I trial of D-PLEX100, with about 480 patients enrolled to date. Following FDA agreement that a single pivotal study suffices for potential approval, the company aims to reach approximately 900 patients for robust data. Cash runway has extended to year-end 2022, a notable improvement from earlier estimates. Despite a net loss of $9.9 million for Q3 2021, a decrease from $6.5 million in Q3 2020, PolyPid remains positioned for clinical and commercial advancements.
PolyPid Ltd. (Nasdaq: PYPD) will report its third quarter 2021 financial results and operational highlights on November 10, 2021, before U.S. markets open. The company is focused on developing therapeutics using its PLEX technology, currently advancing its lead candidate D-PLEX100 through Phase 3 clinical trials aimed at preventing surgical site infections. A conference call and webcast will take place at 8:30 AM ET on the same day to discuss results and updates.
PolyPid Ltd. (Nasdaq: PYPD) announced its participation in the Cantor Fitzgerald Virtual Global Healthcare Conference scheduled for September 29 at 2:00 PM EDT. During the event, Dikla Czaczkes Akselbrad, EVP and CFO, will present corporate highlights and discuss recent developments, particularly focusing on PolyPid's Phase 3 clinical trials for its lead product candidate D-PLEX100, aimed at preventing surgical site infections.
PolyPid specializes in developing targeted therapeutics using its proprietary PLEX technology.
PolyPid Ltd. (Nasdaq: PYPD) announced promising preclinical results for OncoPLEX, a therapy designed for glioblastoma multiform (GBM), demonstrating significant inhibition of tumor growth in two animal models. A single application of OncoPLEX achieved 98% tumor growth inhibition and a 60% survival rate after 41 days, outperforming systemic treatments. The company is preparing for a pre-IND meeting with the U.S. FDA by year-end and aims to initiate a phase 1/2 clinical trial in 2022. The results highlight OncoPLEX's potential to improve patient outcomes in aggressive brain tumors.
PolyPid Ltd. (Nasdaq: PYPD) announced that its Co-Founder and CSO, Dr. Noam Emanuel, will present virtually at the World Association against Infection in Orthopaedics and Trauma Congress on August 28, 2021. The presentation, titled Improved Healing of Gustilo Type IIIA and IIIB Open Long Bone Fractures, focuses on a clinical trial of a biodegradable antibiotic bone graft. This session aims to discuss septic non-union and bone loss management and will be attended by 1,700 members globally.
PolyPid Ltd. (PYPD) announced significant recruitment progress in its Phase 3 SHIELD I trial for D-PLEX100, with over 300 patients enrolled. The FDA indicated that a single Phase 3 study might suffice for D-PLEX100's approval in colorectal surgery. Additionally, PolyPid has chosen brain tumors as the initial target for its OncoPLEX therapy. Financially, R&D expenses rose to $7.4 million in Q2 2021, while net losses decreased to $10.5 million compared to $19.1 million in 2020. The company maintains a cash position of $52.9 million, projected to sustain operations into late 2022.
PolyPid Ltd. (Nasdaq: PYPD), a biopharma company focused on improving surgical outcomes with advanced therapeutics, announced that Dikla Czaczkes Akselbrad, Executive Vice President and CFO, will present at the Investor Summit Virtual Conference on August 18, 2021, at 9:30 am ET. The event is scheduled from August 17-18, 2021, with opportunities for one-on-one meetings throughout. PolyPid's lead product candidate, D-PLEX100, is currently in Phase 3 clinical trials aimed at preventing surgical site infections.
PolyPid Ltd. (Nasdaq: PYPD) announced its second quarter 2021 financial results will be reported before the U.S. markets open on August 11, 2021. The company will hold a conference call at 8:30 AM Eastern Time to discuss these results and operational updates. PolyPid specializes in locally administered therapeutics aimed at improving surgical outcomes, with its lead candidate D-PLEX100 currently in Phase 3 trials to prevent surgical site infections. The company emphasizes its proprietary PLEX technology for effective drug delivery.
PolyPid Ltd. (Nasdaq: PYPD) has appointed renowned colorectal surgeon Dr. Anthony J. Senagore as its Senior Medical Director. Dr. Senagore will lead the development of PolyPid’s medical infrastructure in the U.S. and play a pivotal role in the NDA submission for D-PLEX100, aimed at preventing surgical site infections (SSIs). His extensive experience in surgery and healthcare economics is expected to enhance the company’s mission to improve surgical outcomes. The D-PLEX100 candidate is currently in Phase 3 clinical trials.
PolyPid (Nasdaq: PYPD) announced a presentation by CFO Dikla Czaczkes Akselbrad at The Raymond James Human Health Innovation Conference on June 23, 2021, at 9:20 am EDT. The conference aims to highlight innovations in healthcare, with PolyPid focusing on improving surgical outcomes through its proprietary PLEX technology, which enhances drug delivery. The lead candidate, D-PLEX100, is undergoing Phase 3 trials for preventing surgical site infections. The presentation will be available on the company’s Investor Relations site for 90 days following.
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