# PolyPid Completes New Drug Application Submission to FDA for D-PLEX₁₀₀
Canonical URL: https://biopharmsignal.com/news/PYPD/polypid-completes-new-drug-application-submission-to-fda-for-d-plex
Ticker: PYPD
Company: PolyPid
Source: PolyPid
Published: 2026-06-25 13:46 EST
Original Source URL: https://investors.polypid.com
## Summary

If approved, D-PLEX 100 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: PYPD) (“PolyPid” or the

## Article Body
If approved, D-PLEX 100 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: PYPD) (“PolyPid” or the
## Recent Company News
- 2026-06-25 13:46 EST — [PolyPid Completes New Drug Application Submission to FDA for D-PLEX₁₀₀](https://biopharmsignal.com/news/PYPD/polypid-completes-new-drug-application-submission-to-fda-for-d-plex) — Source: PolyPid
- 2026-06-25 13:46 EST — [PolyPid to Participate in the Craig-Hallum 23rd Annual Institutional Investor Conference](https://biopharmsignal.com/news/PYPD/polypid-to-participate-in-the-craig-hallum-23rd-annual-institutional-investor-conference) — Source: PolyPid
- 2026-06-25 13:46 EST — [PolyPid Provides Corporate Update and Reports First Quarter 2026 Financial Results](https://biopharmsignal.com/news/PYPD/polypid-provides-corporate-update-and-reports-first-quarter-2026-financial-results) — Source: PolyPid
- 2026-06-25 13:46 EST — [PolyPid Announces Positive FDA Pre-NDA Meeting Minutes for D-PLEX₁₀₀ Supporting NDA Submission](https://biopharmsignal.com/news/PYPD/polypid-announces-positive-fda-pre-nda-meeting-minutes-for-d-plex-supporting-nda-submission) — Source: PolyPid
- 2026-06-25 13:46 EST — [PolyPid Appoints Veteran MedTech Leader Brooke Story as Chairman of the Board of Directors](https://biopharmsignal.com/news/PYPD/polypid-appoints-veteran-medtech-leader-brooke-story-as-chairman-of-the-board-of-directors) — Source: PolyPid
## Related News
- 2026-07-21 12:00 EST — MOR — [Novartis delivered sales growth in Q2 and further advanced the pipeline; Full-year guidance reaffirmed](https://biopharmsignal.com/news/MOR/novartis-delivered-sales-growth-in-q2-and-further-advanced-the-pipeline-full-yea-63a32b47)
- 2026-07-20 20:05 EST — RANI — [Rani Therapeutics Reports Inducement Grant Under Nasdaq Listing Rule 5635(c)(4)](https://biopharmsignal.com/news/RANI/rani-therapeutics-reports-inducement-grant-under-nasdaq-listing-rule-5635-c-4-ec56b3b0)
- 2026-07-20 14:53 EST — IPHA — [Innate Pharma announces Completion of Enrollment in Phase 1 Dose Escalation Study of IPH4502, a Novel Nectin-4 Exatecan Antibody-Drug Conjugate (ADC)](https://biopharmsignal.com/news/IPHA/innate-pharma-announces-completion-of-enrollment-in-phase-1-dose-escalation-stud-0778493f)
- 2026-07-20 13:05 EST — ACAD — [Acadia Pharmaceuticals Receives FDA Fast Track Designation for Remlifanserin in Alzheimer's Disease Psychosis](https://biopharmsignal.com/news/ACAD/acadia-pharmaceuticals-receives-fda-fast-track-designation-for-remlifanserin-in--f36b622c)
- 2026-07-20 13:00 EST — ENLV — [Enlivex Treasury Portfolio Update: NAV Per Ordinary Share $66.16; Total Treasury Holdings Valued at Approximately $1.1 Billion](https://biopharmsignal.com/news/ENLV/enlivex-treasury-portfolio-update-nav-per-ordinary-share-66-16-total-treasury-ho-9d036ef9)