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), 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.
PolyPid Ltd. (Nasdaq: PYPD) is a biopharma company focused on enhancing surgical outcomes with controlled, extended-release therapeutics. On June 2, 2021, the company announced its executive team will present at three upcoming healthcare investor conferences: the LD Micro Invitational XI on June 10, the JMP Securities Life Sciences Conference on June 16, and the Raymond James Human Health Innovation Conference on June 21. The Raymond James presentation will be webcast live and available for 90 days on PolyPid's Investor Relations website.
PolyPid Ltd. (PYPD) announced FDA approval for a single pivotal Phase 3 study of D-PLEX100 for preventing surgical site infections (SSIs) in colorectal surgery. This decision is based on the adequate results expected from the SHIELD I trial, which has already enrolled over 200 patients. The trial aims to include a total of 616 to 900 participants across multiple centers and is set to deliver top-line results by year-end 2021. This breakthrough designation could expedite development and reduce costs significantly, addressing a major healthcare issue costing up to $10 billion annually.
PolyPid Ltd. (Nasdaq: PYPD) announced significant recruitment progress in its Phase 3 SHIELD I trial of D-PLEX100, with nearly 200 patients enrolled, a doubled recruitment rate in the last three weeks. The manufacturing facility is fully equipped to meet the first 30 months of commercial demand for D-PLEX100. Financial results reveal a net loss of $8.7 million for Q1 2021, an increase from $5.9 million in Q1 2020. Cash reserves stand at $61.4 million, expected to sustain operations into 2022. Top-line results for SHIELD I are anticipated by year-end 2021.
PolyPid Ltd. (Nasdaq: PYPD) announced it will release its first quarter 2021 financial results on May 12, 2021, before the U.S. market opens. A conference call is scheduled for 8:30 AM ET to discuss the results and business updates. PolyPid is focused on enhancing surgical outcomes through its patented PLEX technology, which offers controlled drug delivery over extended periods. Their lead candidate, D-PLEX100, is currently undergoing Phase 3 trials targeting surgical site infections.
PolyPid Ltd. (Nasdaq: PYPD) announced its participation in two major healthcare conferences. The company will present at the Raymond James 42nd Annual Institutional Investors Conference on March 3, 2021, at 8:20 AM Eastern Time, and at the Barclays Global Healthcare Conference on March 9, 2021, at 7:30 AM Eastern Time. Both events will feature one-on-one investor meetings, and webcasts will be available for replay. PolyPid focuses on improving surgical outcomes with its extended-release therapeutics.
PolyPid Ltd. (Nasdaq: PYPD) announced the enrollment of the 100th patient in its Phase 3 SHIELD I clinical trial, focused on preventing surgical site infections (SSIs) following abdominal surgery. The trial aims to enroll between 616 to 900 patients across over 60 centers globally. Top-line results are anticipated by the end of 2021. PolyPid's lead product, D-PLEX100, utilizes proprietary technology for prolonged antibiotic release, receiving Breakthrough Therapy Designation from the FDA for specific surgical procedures.
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