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), 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.
PolyPid (Nasdaq: PYPD), a late-stage biopharma company focused on improving surgical outcomes, has announced its participation in the upcoming Lytham Partners Spring 2025 Investor Conference. The virtual event will take place on May 29, 2025.
The company will deliver a webcast presentation at 10:15 a.m. ET and conduct one-on-one meetings with investors throughout the event. The presentation will be accessible through the conference website and will be available for replay after the event.