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 (Nasdaq: PYPD) will report fourth quarter 2025 financial results and operational highlights before U.S. markets open on February 11, 2026, and will host a conference call and webcast at 8:30 AM ET.
The company said it expects to submit a New Drug Application (NDA) for D-PLEX100 in early 2026 after positive Phase 3 results; D-PLEX100 targets prevention of abdominal colorectal surgical site infections. Registration and webcast links are provided for investors.
PolyPid (Nasdaq: PYPD) appointed Brooke Story as Chairman of the Board, effective December 11, 2025. The company said Story brings >25 years of MedTech leadership with senior roles at BD and Medtronic and experience overseeing P&L for surgical portfolios including infection prevention, hernia and tissue repair.
Management noted Story’s transaction experience in mergers, acquisitions and licensing and her current role as BD’s Separation and Integration Lead. The appointment is positioned to support PolyPid’s planned NDA submission for D-PLEX₁₀₀ and to help translate clinical progress into commercial execution.
PolyPid (Nasdaq: PYPD) announced written pre‑NDA meeting minutes from the U.S. FDA that support a rolling NDA submission for D‑PLEX100 to prevent surgical site infections in abdominal colorectal surgery.
The FDA agreed the company’s existing clinical data package, including results from the Phase 3 SHIELD II trial, appears adequate to support NDA submission and review, and agreed to a rolling NDA allowing the first completed sections to be submitted in early 2026. The company said the objectives of the pre‑NDA meeting were accomplished and an in‑person meeting scheduled for December 3, 2025 is no longer necessary.
PolyPid (Nasdaq: PYPD) will participate in a virtual Key Opinion Leader event hosted by ROTH Capital Partners on Wednesday, December 10, 2025 at 11:30 AM ET.
The webinar, titled “The Science and Business Case for D-PLEX 100 (Tackling Surgical Site Infections)”, features colorectal surgeon Steven D. Wexner, MD, who will discuss the clinical and economic burden of surgical site infections (SSIs), current prevention strategies and limitations, and the potential role of D-PLEX100 in abdominal colorectal and other surgical settings. The session will be moderated by Boobalan Pachaiyappan, Ph.D., and will include a live Q&A with PolyPid management.
Investors and clinicians can register via the ROTH registration link provided by the host.
PolyPid (Nasdaq: PYPD) provided a corporate update and reported Q3 2025 results on November 12, 2025. Key operational highlights include a face-to-face pre-NDA meeting with the FDA scheduled for early December and an NDA submission for D-PLEX₁₀₀ on track for early 2026, following positive Phase 3 SHIELD II results. The company completed a successful IMOH GMP inspection (fourth consecutive) and is advancing U.S. partnership discussions. Financially, Q3 net loss was $7.5M (−$0.37/share); nine-month net loss was $25.7M (−$1.72/share). Cash and equivalents were $18.8M as of September 30, 2025, which the company expects will fund operations into 2026.
PolyPid (Nasdaq: PYPD) announced that its lead candidate D-PLEX₁₀₀ won BioTech Breakthrough's Therapeutics Solution of the Year award on Nov 6, 2025. D-PLEX₁₀₀ is a localized, 30-day doxycycline delivery platform aimed at preventing surgical site infections (SSIs).
The company reported Phase 3 SHIELD II results showing a 58% relative risk reduction in SSIs after abdominal colorectal surgery (p<0.005). D-PLEX₁₀₀ holds Breakthrough Therapy, three QIDP and three Fast Track designations from the FDA, and an NDA submission is expected early 2026.
PolyPid (Nasdaq: PYPD) said it will report third quarter 2025 financial results and operational highlights before U.S. markets open on Wednesday, November 12, 2025.
The company will host a conference call and webcast at 8:30 AM Eastern Time; registration is recommended at least five minutes before the call. Webcast and dial-in links are provided for live access.
PolyPid noted that following positive Phase 3 results, submission of a New Drug Application (NDA) for D-PLEX100 to prevent abdominal colorectal surgical site infections is expected in early 2026. The company also referenced an oncology, obesity and diabetes pipeline.
PolyPid (Nasdaq: PYPD), a late-stage biopharma company, announced that Dr. Shmuel Sharoni will present the topline results from their successful Phase 3 SHIELD II trial of D-PLEX₁₀₀ at the 2025 American College of Surgeons (ACS) Clinical Congress in Chicago.
The presentation, titled "Efficacy Of A Novel Local Prolonged-release Incisional Doxycycline On Surgical Site Infection Prophylaxis In Abdominal Colorectal Surgery: The Shield II Phase 3 Randomized Clinical Trial," will take place during the high-impact clinical trials session on October 5, 2025, at 11:30 AM CT at McCormick Place.
PolyPid (Nasdaq: PYPD), a late-stage biopharma company focused on surgical outcomes improvement, has announced its participation in two upcoming investor conferences. The company will present at the Lytham Partners Fall 2025 Virtual Investor Conference on September 30, 2025, featuring a fireside chat at 4:15 p.m. ET with Craig-Hallum Senior Research Analyst Chase Knickerbocker.
Additionally, PolyPid's management will attend the 4th Annual ROTH Healthcare Opportunities Conference on October 9, 2025, at the Metropolitan Club in New York, where they will conduct one-on-one meetings with investors.
PolyPid (Nasdaq: PYPD) has successfully completed its fourth consecutive Good Manufacturing Practice (GMP) inspection by the Israeli Ministry of Health for its manufacturing facility. The inspection, operating under the EU-Israel Agreement on Conformity Assessment and Acceptance (ACAA), validates the facility's compliance with European market standards.
This milestone strengthens PolyPid's position as it prepares for its planned New Drug Application (NDA) submission for D-PLEX₁₀₀ in early 2026. The successful inspection serves as preparation for the upcoming FDA facility inspection and confirms the company's readiness for commercial production following the positive Phase 3 SHIELD II trial results.
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