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) reported first quarter 2026 results and regulatory progress for D-PLEX₁₀₀. The NDA to the FDA was initiated March 30, 2026 under rolling review, with completion expected imminently and a PDUFA fee waiver of about $4.3 million.
EMA meetings are planned in Q2 2026, with an MAA filing targeted for Q3 2026. U.S. commercial partnership talks are in late stages. Q1 2026 net loss was $7.7 million ($0.35 per share). Cash and equivalents were $10.9 million, supported by $4.0 million warrant proceeds and full repayment of a $0.8 million venture loan.
PolyPid (Nasdaq: PYPD) will report first quarter 2026 financial results and operational highlights before U.S. markets open on Wednesday, May 13, 2026.
The company will host a conference call and webcast at 8:30 AM Eastern Time. Registration is recommended at least 5 minutes before the call; a webcast option is available for listeners.
PolyPid (Nasdaq: PYPD) announced presentation of Phase 3 SHIELD II ASEPSIS score analysis showing a 64% relative risk reduction (p=0.0103) in patients with ASEPSIS>20 and a previously reported 60% RRR in SSI incidence (p=0.0013) after abdominal colorectal surgery. D-PLEX100 holds FDA Breakthrough Therapy designation for SSI prevention.
The data suggest fewer high-severity wound infections and potential reductions in antibiotic use, hospital stay, and resource utilization; results will be presented May 6, 2026 at the Surgical Infection Society annual meeting.
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.