News
PolyPid Completes New Drug Application Submission to FDA for D-PLEX
If approved, D-PLEX100 would address a critical unmet medical need in the prevention of surgical site infections PDUFA target action date currently planned for the first quarter of 2027 PETACH TIKVA, Israel, June 01, 2026 (GLOBE NEWSWIRE) -- PolyPid Ltd. (Nasdaq:...
PolyPid to Participate in the Craig-Hallum 23rd Annual Institutional Investor Conference
PETACH TIKVA, Israel, May 20, 2026 (GLOBE NEWSWIRE) -- 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...
PolyPid Provides Corporate Update and Reports First Quarter 2026 Financial Results
Initiated NDA Submission to the FDA for D-PLEX ; Completion Expected Imminently U.S. Commercial Partnership Discussions in Late Stages Conference Call Scheduled for Today at 8:30 AM ET PETACH TIKVA, Israel, May 13, 2026 (GLOBE NEWSWIRE) -- PolyPid Ltd. (Nasdaq: PYPD)...
PolyPid to Report First Quarter 2026 Financial Results and Operational Highlights on May 13, 2026
PETACH TIKVA, Israel, May 06, 2026 (GLOBE NEWSWIRE) -- 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...
PolyPid to Present Data from SHIELD II Phase 3 Trial Demonstrating Reduced Severity of Surgical Site Infection at Surgical Infection Society 2026 Annual Meeting
Analysis demonstrates statistically significant reduction in the severity of surgical wound infections, with potential to lower hospital resource utilization following abdominal colorectal surgery PETACH TIKVA, Israel, April 28, 2026 (GLOBE NEWSWIRE) -- PolyPid Ltd....
PolyPid to Present New Phase 3 SHIELD II Data Demonstrating D-PLEX Sustained Local Release at ESCMID Global 2026
Analysis demonstrates D-PLEX prolonged delivery mechanism ability to deliver continuous release of doxycycline for 30 days at the surgical incision sitePETACH TIKVA, Israel, April 13, 2026 (GLOBE NEWSWIRE) -- PolyPid Ltd. (Nasdaq: PYPD) ("PolyPid" or the "Company"),...
PolyPid Initiates D-PLEX NDA Submission to the FDA
PolyPid Submits First Modules as Part of Rolling NDA Review; Completion expected in Second Quarter of 2026 U.S. Commercialization Partnership Negotiations on Track PETACH TIKVA, Israel, March 31, 2026 (GLOBE NEWSWIRE) -- PolyPid Ltd. (Nasdaq: PYPD) ("PolyPid" or the...
PolyPid Receives PDUFA Fee Waiver from FDA for D-PLEX ‘s New Drug Application
FDA Grants $4.3 Million Small Business Waiver, Enabling Focus on Commercialization Preparations Company On Track to Initiate NDA Submission by the End of this Month PETACH TIKVA, Israel, March 17, 2026 (GLOBE NEWSWIRE) -- PolyPid Ltd. (Nasdaq: PYPD) ("PolyPid" or the...
PolyPid Announces Participation in Upcoming Investor Conferences
PETACH TIKVA, Israel, Feb. 25, 2026 (GLOBE NEWSWIRE) -- 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...
PolyPid Provides Corporate Update and Reports Fourth Quarter and Full-Year 2025 Financial Results
The Company is in Advanced Stages of Commercial U.S. Partnership Discussions for D-PLEX Positive FDA Pre-NDA Feedback Supports Rolling NDA Review; Submission Expected to Begin by the End of the First Quarter of 2026 Conference Call Scheduled for Today at 8:30 AM ET...