Welcome to our dedicated page for Polypid news (Ticker: PYPD), a resource for investors and traders seeking the latest updates and insights on Polypid stock.
PolyPid Ltd. develops locally administered, controlled-release therapeutics based on its proprietary PLEX drug-delivery technology. The company’s lead product candidate, D-PLEX100, is designed for prevention of surgical site infections in abdominal colorectal surgery, and company updates commonly cover Phase 3 SHIELD II data, pharmacokinetics, FDA interactions, New Drug Application activity, and manufacturing-readiness topics.
PolyPid news also includes financial results, operational highlights, investor-conference participation, and broader pipeline references spanning surgical care, oncology, obesity, diabetes, and other metabolic-disease applications. Recurring disclosures focus on clinical and regulatory progress, product-candidate development, and the financing and business updates typical of a late-stage biopharmaceutical issuer.
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.
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.