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 publicly described as a late-stage biopharma company aiming to improve surgical outcomes through locally administered, controlled, prolonged-release therapeutics. News about PolyPid often centers on the development and regulatory progress of its lead product candidate, D-PLEX100, and on milestones related to its proprietary PLEX (Polymer-Lipid Encapsulation matriX) drug delivery technology.
Investors and observers following PYPD news will find updates on clinical trial results, particularly from the Phase 3 SHIELD II trial of D-PLEX100 in abdominal colorectal surgeries. Company press releases report that this trial met its primary and key secondary endpoints and demonstrated reductions in surgical site infections and related outcomes when D-PLEX100 was added to standard of care.
Regulatory developments are another major theme in PolyPid’s news flow. The company has announced that D-PLEX100 received Breakthrough Therapy designation from the U.S. Food and Drug Administration and has reported positive pre-NDA meeting minutes supporting a New Drug Application submission. News items also describe the FDA’s agreement to a rolling NDA review, which PolyPid highlights as an important step in its regulatory strategy.
Corporate and operational updates appear regularly, including GMP inspection outcomes for the company’s manufacturing facility by the Israeli Ministry of Health, which PolyPid states support its readiness for potential commercial production. Additional news covers participation in medical and investor conferences, board and management changes such as the appointment of a new chairman of the board, and financial results reported via quarterly updates.
For readers tracking PYPD, this news stream provides insight into PolyPid’s clinical progress, regulatory interactions, manufacturing readiness and capital markets activity, all framed around its goal of improving surgical outcomes with prolonged-release therapeutics.
PolyPid Ltd. (Nasdaq: PYPD) has appointed Dr. Mitchel S. Berger to its Oncology Advisory Board to enhance its expertise in brain tumor treatment. Dr. Berger, a leading figure in neurosurgery, is expected to contribute significantly to the development of OncoPLEX, PolyPid’s intra-tumoral therapy targeting glioblastoma multiforme (GBM). The company plans to initiate a Phase 1/2 clinical trial for OncoPLEX by the end of 2022, following positive preclinical results. This advancement aims to improve local chemotherapy delivery and patient outcomes in challenging brain tumors.
PolyPid Ltd. (Nasdaq: PYPD) announced the appointment of Dikla Czaczkes Akselbrad as its new CEO, effective July 1, 2022. Akselbrad, previously the company's EVP and CFO, takes over from Amir Weisberg, who has led PolyPid for over 11 years. During her tenure, she has played a vital role in guiding the company through significant financial and operational transitions. PolyPid is advancing its Phase 3 clinical program for D-PLEX100, aimed at preventing surgical site infections, while preparing for commercial launch.
PolyPid Ltd. (PYPD) announced enrollment of the 500th patient in its Phase 3 SHIELD I study evaluating D-PLEX100 for preventing surgical site infections (SSIs) following abdominal surgery. The company aims to complete enrollment by Q2 2022 and expects top-line results two months later. D-PLEX100 offers prolonged antibiotic release at the surgical site and has received Breakthrough Therapy Designation from the FDA.
SHIELD I involves around 900 patients across 60 centers in the U.S., Europe, and Israel. Positive trial results could lead to FDA approval.
PolyPid Ltd. (Nasdaq: PYPD) announced the appointment of Frederick Lang, M.D., to its Oncology Advisory Board, effective November 2021. Dr. Lang, a prominent figure at MD Anderson, co-leads the Glioblastoma Moon Shot initiative, focusing on brain cancer. The company is set to conduct a pre-IND meeting with the U.S. FDA later this month to potentially initiate a Phase 1/2 clinical trial of its intra-tumoral therapy, OncoPLEX, in 2022. OncoPLEX aims to enhance localized drug delivery for treating aggressive brain tumors, addressing significant treatment challenges.
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.
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