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) 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.
PolyPid (NASDAQ: PYPD), a late-stage biopharma company focused on improving surgical outcomes, will participate in the 27th Annual H.C. Wainwright Global Investment Conference on September 8-9, 2025, at the Lotte New York Palace Hotel in New York City.
The company's management will engage in a fireside chat with H.C. Wainwright Managing Director Brandon Folkes on Monday, September 8, from 11:30 AM to 12:00 PM ET. Additionally, the management team will be available for one-on-one meetings with investors, which can be arranged through H.C. Wainwright representatives or via meetings@hcwco.com.
PolyPid (Nasdaq: PYPD), a late-stage biopharma company focused on improving surgical outcomes, has announced its participation in the 14th Israel Controlled Release Society (ICRS) Conference. The company's Deputy CEO and EVP of R&D, Clinical, and Regulatory Affairs, Dalit Hazan, will deliver a presentation titled "Novel Local Prolonged Drug Delivery: From Platform Idea to a Successful Phase III Trial" on September 7, 2025.
The presentation is scheduled for 5:25 PM - 5:45 PM local time at the Enjoy Hotel, Dead Sea, Israel, as part of Session 1 on "Advances in Targeted and Controlled Drug Delivery."
PolyPid (NASDAQ:PYPD) announced significant milestones in Q2 2025, highlighted by positive Phase 3 SHIELD II trial results for D-PLEX₁₀₀. The trial demonstrated a 58% reduction in surgical site infections (SSIs) and met its primary efficacy endpoint with a 38% reduction (p<0.005).
Key developments include plans for NDA submission in Q1 2026, unveiling of a novel long-acting GLP-1 delivery platform for obesity and diabetes, and appointment of Dr. Nurit Tweezer-Zaks as CMO. The company reported a Q2 2025 net loss of $10.0 million ($0.78 per share) and strengthened its balance sheet through warrant exercises, extending cash runway into 2026 with $29.5 million in cash and equivalents.
PolyPid (NASDAQ:PYPD), a late-stage biopharma company, has appointed Dr. Nurit Tweezer-Zaks as Chief Medical Officer, effective August 18, 2025. Dr. Tweezer-Zaks will transition from her current role on PolyPid's Board of Directors, which she has held since November 2023.
The appointment follows positive Phase 3 SHIELD II trial results and comes at a crucial time as the company prepares for its New Drug Application (NDA) submission. Dr. Tweezer-Zaks brings significant experience from her roles as CEO of MediCane Health Inc., CMO at aMOON Venture Capital Fund, and various positions at Sanofi, along with 15 years as a practicing physician at Sheba Medical Center.
PolyPid (Nasdaq: PYPD), a late-stage biopharma company focused on improving surgical outcomes, has scheduled its second quarter 2025 financial results announcement for August 13, 2025, before U.S. markets open.
The company will host a conference call and webcast at 8:30 AM Eastern Time to discuss quarterly results and provide business updates. Management recommends participants register at least 5 minutes before the call, with a webcast option available for those not planning to ask questions.
PolyPid (Nasdaq: PYPD) has unveiled a breakthrough long-acting GLP-1 receptor agonists delivery platform targeting diabetes and weight loss markets. The company's proprietary technology enables subcutaneous GLP-1 delivery for approximately 60 days, significantly improving upon current weekly injection standards.
The platform features linear drug release, addressing burst release issues common in weekly delivered molecules. The technology utilizes a polymer-lipid based matrix creating a protected drug reservoir, and has been clinically validated in over 1,000 patients including two Phase 3 trials with no major safety concerns. This expansion targets a market projected to reach $100 billion by 2030.