PolyPid Ltd. POLY 深 沪

PolyPid to Report First Quarter 2026 Financial Results and Operational Highlights on May 13, 2026

PolyPid Ltd. (Nasdaq: PYPD) announced it will report its first quarter 2026 financial results and operational highlights on Wednesday, May 13, 2026, before the U.S. market open. A conference call and webcast at 8:30 AM Eastern Time will discuss the results and business updates. The company, focused on improving patient outcomes through innovative biopharmaceuticals, invites participants to register in advance for the call or listen via webcast.

05-06 12:00

PolyPid To Present ASEPSIS Analysis Data From Its Phase 3 SHIELD II Study Of D-PLEX At 5th Annual Meeting Of The Surgical Infection Society

PolyPid Ltd. (NASDAQ:PYPD) ("PolyPid" or the "Company"), an innovative biopharmaceutical company dedicated to improving patient outcomes by elevating treatment effectiveness, right where care begins, today announced that

04-28 20:37

PolyPid To Present Phase 3 SHIELD II Data Showing Sustained Local Doxycycline Release And Minimal Systemic Exposure At ESCMID 2026 Conference

PolyPid Ltd. (NASDAQ:PYPD) ("PolyPid" or the "Company"), an innovative biopharmaceutical company dedicated to improving patient outcomes by elevating treatment effectiveness, right where care begins, today announced that

04-13 21:16

PolyPid Initiates D-PLEX₁₀₀ NDA Submission to the FDA

PolyPid Ltd. has initiated the submission of its New Drug Application (NDA) to the FDA for D-PLEX₁₀₀, aimed at preventing surgical site infections (SSIs) in colorectal surgery patients. The submission, under the FDA’s Fast Track designation, includes the Chemistry, Manufacturing and Controls (CMC) and nonclinical sections, with the clinical section expected in the second quarter of 2026. D-PLEX₁₀₀, which uses PolyPid’s Kynatrix technology, provid...

03-31 12:30

PolyPid Receives PDUFA Fee Waiver from FDA for D-PLEX₁₀₀’s New Drug Application

PolyPid Ltd. announced that the FDA has granted a $4.3 million small business waiver for its New Drug Application (NDA) for D-PLEX₁₀₀, aimed at preventing surgical site infections in abdominal colorectal surgeries. This waiver supports the company's commercialization efforts and enables it to focus on submitting the first sections of its rolling NDA by the end of this month. D-PLEX₁₀₀ demonstrated a 60% relative risk reduction in infections in th...

03-17 12:30

PolyPid Appoints Brooke Story As Board Chairman, Effective Dec. 11

PolyPid Ltd. (Nasdaq: PYPD) ("PolyPid" or the "Company"), a late-stage biopharma company aiming to improve surgical outcomes, today announced the appointment of Brooke Story as Chairman of the Board of Directors,

2025-12-16 21:33

PolyPid Appoints Veteran MedTech Leader Brooke Story as Chairman of the Board of Directors

PolyPid Ltd. announced the appointment of Brooke Story as Chairman of its Board of Directors. With over 25 years of leadership experience in the MedTech industry, Story will enhance the company’s strategic, commercial, and transaction capabilities. Her expertise in surgical solutions and infection prevention will support PolyPid in advancing its lead product, D-PLEX₁₀₀, which is expected to submit its New Drug Application in early 2026. Story’s l...

2025-12-16 13:30

PolyPid Announces Positive FDA Pre-NDA Meeting Minutes for D-PLEX₁₀₀ Supporting NDA Submission

PolyPid Ltd. has received FDA support for rolling NDA submission of D-PLEX100, its lead product for preventing surgical site infections in colorectal surgeries. The FDA agreed the company's existing clinical data, including Phase 3 results, is adequate for submission. PolyPid plans to submit the first sections in early 2026, with the Breakthrough Therapy designation further validating its regulatory strategy.

2025-12-03 13:30

PolyPid to Participate in ROTH Capital Partners Virtual KOL Event on December 10, 2025

2025-11-25 13:30

PolyPid Advances D-PLEX₁₀₀ Towards FDA Submission and Commercial Readiness

PolyPid ( ($PYPD) ) has shared an announcement. PolyPid Ltd. announced its thir...

2025-11-12 20:56