FDA Events for PolyPid (PYPD)
This section highlights FDA-related milestones and regulatory updates for drugs developed by PolyPid (PYPD).
Over the past two years, PolyPid has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
D-PLEX100. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
D-PLEX100 - FDA Regulatory Timeline and Events
D-PLEX100 is a drug developed by PolyPid for the following indication: Surgical Site Infections in Colorectal Surgery.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- D-PLEX100
- Announced Date:
- June 9, 2025
- Indication:
- Surgical Site Infections in Colorectal Surgery
Announcement
PolyPid Ltd. announced positive topline results from its pivotal SHIELD II Phase 3 trial of D-PLEX100 for the prevention of SSIs in patients undergoing abdominal colorectal surgery with large incisions, which has received Fast Track designation from the FDA.
AI Summary
PolyPid Ltd. announced positive topline results from its pivotal SHIELD II Phase 3 trial evaluating D-PLEX100 to prevent surgical site infections (SSIs) in patients undergoing abdominal colorectal surgery with large incisions. The trial met its primary efficacy endpoint with statistically significant results (p<0.005) and showed a 58% reduction in SSIs compared to the standard of care. These outcomes highlight D-PLEX100’s potential to lower costs and improve patient care by reducing infection risk and supporting better clinical recovery.
The innovative product, which uses a controlled release of the antibiotic doxycycline at the surgical site, has received Fast Track designation from the U.S. Food and Drug Administration. PolyPid plans to submit a New Drug Application to the FDA in early 2026, aiming to offer a valuable new tool to address the significant unmet need in managing surgical site infections.
Read Announcement- Drug:
- D-PLEX100
- Announced Date:
- June 6, 2025
- Indication:
- Surgical Site Infections in Colorectal Surgery
Announcement
PolyPid Ltd. announced that it will host a conference call and webcast to report topline data for the SHIELD II Phase 3 trial, evaluating D-PLEX100 for the prevention of surgical site infections in patients undergoing abdominal colorectal surgery, on Monday, June 9, at 8:30 a.m. ET.
AI Summary
PolyPid Ltd., a biopharma company focused on improving surgical outcomes, announced it will host a conference call and webcast on Monday, June 9, 2025 at 8:30 a.m. ET. During the call, the company will share topline data from the SHIELD II Phase 3 trial, which is testing D-PLEX100 for the prevention of surgical site infections in patients undergoing abdominal colorectal surgery.
Attendees are advised to register at least five minutes before the start of the call to ensure a smooth connection. This event highlights an important step in evaluating how D-PLEX100 can help reduce post-surgery complications through precise, prolonged-release therapy. The conference call and webcast will provide key insights into the trial’s outcomes and PolyPid’s ongoing efforts to enhance surgical care. Participants can join the event using the provided web links.
Read Announcement- Drug:
- D-PLEX100
- Announced Date:
- March 11, 2025
- Indication:
- Surgical Site Infections in Colorectal Surgery
Announcement
PolyPid Ltd. announced the successful completion of enrollment in the SHIELD II Phase 3 trial for D-PLEX100 for the prevention of surgical site infections in patients undergoing abdominal colorectal surgery.
AI Summary
PolyPid Ltd. announced that it has successfully completed enrollment for its SHIELD II Phase 3 trial of D-PLEX100, a treatment aimed at preventing surgical site infections in patients undergoing abdominal colorectal surgery. The trial enrolled a total of 800 patients, following a recommendation from an independent Data Safety Monitoring Board after analyzing data from the initial 430 patients. This milestone marks a key step in evaluating D-PLEX100’s effectiveness in being administered alongside standard care during surgery.
The company expects to share top-line results by the end of the second quarter of 2025. If the data proves favorable, PolyPid plans to arrange a meeting with the FDA to discuss a rolling New Drug Application submission. This progress reinforces PolyPid’s commitment to improving surgical outcomes and reducing postoperative infection risks for patients undergoing complex abdominal surgeries.
Read Announcement- Drug:
- D-PLEX100
- Announced Date:
- December 24, 2024
- Indication:
- Surgical Site Infections in Colorectal Surgery
Announcement
PolyPid Ltd. announced today that following the independent Data Safety Monitoring Board's ("DSMB") review of unblinded efficacy data from the first 430 enrolled patients in the SHIELD II Phase 3 trial for D-PLEX100 for the prevention of surgical site infections ("SSIs") in patients undergoing abdominal colorectal surgery with large incisions, the DSMB's recommendation was to conclude the study upon enrollment of 800 patients, which is the lowest sample size reassessment stop after the minimum planned number of 624 patients.
AI Summary
PolyPid Ltd. announced that an independent Data Safety Monitoring Board (DSMB) has reviewed unblinded efficacy data from the first 430 patients enrolled in the SHIELD II Phase 3 trial for D-PLEX100, which is designed to prevent surgical site infections in patients undergoing abdominal colorectal surgery. Based on the review, the DSMB recommended that the study conclude enrollment at 800 patients. This figure represents the lowest sample size stop after the minimum planned 624 patients, suggesting that D-PLEX100 is showing promising efficacy signals. The DSMB’s decision also came with the flexibility to halt the trial early due to futility or overwhelming efficacy, or to increase the sample size to a maximum of 1,100 patients if needed. Additionally, the DSMB confirmed the good safety profile of D-PLEX100 observed so far during the trial.
Read Announcement- Drug:
- D-PLEX100
- Announced Date:
- October 1, 2024
- Estimated Event Date Range:
- January 1, 2025 - March 31, 2025
- Target Action Date:
- Q1 - 2025
- Indication:
- Surgical Site Infections in Colorectal Surgery
Announcement
PolyPid Ltd. announced that Top-line Results Anticipated in First Quarter of 2025
AI Summary
PolyPid Ltd., a late-stage biopharma company focused on improving surgical outcomes, announced progress in its Phase 3 SHIELD II trial for D-PLEX100. This trial is designed to prevent surgical site infections in patients undergoing abdominal colorectal surgery. The company confirmed that the unblinded interim analysis will occur during the current quarter after the last patient completes the 30-day follow-up. Top-line results from the SHIELD II trial are anticipated in the first quarter of 2025. Enrollment is quickly progressing toward full capacity, which is expected by the end of the year. The upcoming analysis will be key in determining whether early trial conclusions can be made due to positive efficacy, or if the study should continue with additional recruitment and potential sample size adjustments. This milestone reflects PolyPid’s commitment to advancing innovative, locally administered antibiotic treatments for surgical patients.
Read Announcement- Drug:
- D-PLEX100
- Announced Date:
- October 1, 2024
- Indication:
- Surgical Site Infections in Colorectal Surgery
Announcement
PolyPid Ltd. announced that it has enrolled the last patient required in order to conduct the planned unblinded interim analysis in its ongoing SHIELD II Phase 3 trial for D-PLEX100 for the prevention of surgical site infections in patients undergoing abdominal colorectal surgery with large incisions.
AI Summary
PolyPid Ltd. announced that it has enrolled the final patient needed to perform the planned unblinded interim analysis in its ongoing SHIELD II Phase 3 trial. This study is testing D-PLEX100, a treatment designed to prevent surgical site infections in patients undergoing abdominal colorectal surgery with large incisions. The planned interim analysis will take place this quarter after all patients complete their 30-day follow-up period. The results of this analysis may allow the trial to end early if positive efficacy is observed or lead to adjustments in patient recruitment, which may ultimately increase the total number of subjects from the current count of approximately 430 to a planned 630. PolyPid aims to release top-line results from the SHIELD II trial in the first quarter of 2025.
Read Announcement
PolyPid FDA Events - Frequently Asked Questions
As of now, PolyPid (PYPD) has not received any FDA approvals for its therapy in the last two years.
In the past two years, PolyPid (PYPD) has reported FDA regulatory activity for D-PLEX100.
The most recent FDA-related event for PolyPid occurred on June 9, 2025, involving D-PLEX100. The update was categorized as "Top-line results," with the company reporting: "PolyPid Ltd. announced positive topline results from its pivotal SHIELD II Phase 3 trial of D-PLEX100 for the prevention of SSIs in patients undergoing abdominal colorectal surgery with large incisions, which has received Fast Track designation from the FDA."
Currently, PolyPid has one therapy (D-PLEX100) targeting the following condition: Surgical Site Infections in Colorectal Surgery.
More FDA Event Resources from MarketBeat
FDA Event Stage Terminology & Abbreviation Guide
- NDA: New Drug Application
- ANDA: Abbreviated New Drug Application
- sNDA: Supplemental New Drug Application
- BLA: Biologics License Application
- sBLA: Supplemental Biologics License Application
- FDA Approved: Approved by the FDA
- EMA: European Medicines Agency
- CE Mark: European Union Certification
- NMPA: China National Medical Products Administration
- MHLW: Japanese Ministry of Health
- FDA Meeting: Consultation with FDA
- Pre-IND: Pre-Investigational New Drug Meeting
- Breakthrough Therapy: Special FDA designation for promising therapies
- Fast Track: Accelerated FDA approval pathway
- Orphan Drug: Designation for rare disease treatments
- RPD: Rare Pediatric Disease Designation
- RMAT: Regenerative Medicine Advanced Therapy
- DSMB Review: Data Safety Monitoring Board Review
- IDMC Review: Independent Data Monitoring Committee
- MAA: MHRA Marketing Authorization Application
- RTF: Refusal to File (Rejected Application)
- 510(k): FDA Clearance for Medical Devices
- Rolling Submission: Staggered regulatory review process
This page (NASDAQ:PYPD) was last updated on 7/11/2025 by MarketBeat.com Staff
