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 present Phase 3 SHIELD II pharmacokinetic data for D-PLEX100 at ESCMID Global 2026 on April 19, 2026. Key results show a sustained, controlled local doxycycline release detectable for 763 hours (~32 days) with plasma levels below 100 ng/mL, indicating minimal systemic exposure versus oral dosing.
The poster (P2740) is authored by Prof. Antonino Spinelli and presented by Eyal Shoshani in Session 05b on April 19, 12:00–13:30 CEST.
PolyPid (Nasdaq: PYPD) has initiated a rolling New Drug Application (NDA) submission to the FDA for D-PLEX₁₀₀, aimed at preventing surgical site infections in colorectal surgery. The company submitted CMC and nonclinical modules under Fast Track and expects the clinical section in Q2 2026.
The move follows positive Phase 3 SHIELD II results and a pre-NDA meeting with the FDA; PolyPid says U.S. commercialization partnership discussions are on track as it advances toward potential approval and launch.
PolyPid (Nasdaq: PYPD) received a $4.3 million PDUFA fee waiver from the FDA for the NDA of D-PLEX₁₀₀, enabling the company to focus resources on commercialization preparations. The company reported Phase 3 SHIELD II showed a 60% relative risk reduction in surgical site infections (p=0.0013).
PolyPid is on track to begin its rolling NDA submission by the end of March 2026 and said it is in advanced U.S. commercial partnership discussions.
PolyPid (Nasdaq: PYPD) announced that senior management will participate in two investor conferences in March 2026.
Events include the Citizens 2026 Life Sciences Conference on March 10 (1:40 PM ET, Eden Roc Miami Beach) and the 38th Annual ROTH Conference on March 23 (12:30 PM PT, The Ritz-Carlton Laguna Niguel).
Both will feature fireside chats; investors seeking one-on-one meetings should contact their Citizens or Roth representative. A webcast signup link is provided for the Citizens event.
PolyPid (Nasdaq: PYPD) reported Q4 and full-year 2025 results and provided a corporate update. Key developments include positive FDA pre-NDA feedback and a planned rolling NDA submission for D-PLEX100 beginning by end of Q1 2026, advanced U.S. partnership discussions, completion of Phase 3 SHIELD II, and cash of $12.9M.
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.