PolyPid completes NDA submission to FDA for D-PLEX100
The submission aims to prevent surgical site infections; PDUFA target in Q1 2027.
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Developer of long-acting controlled-release medicines
polypid.com- Headquarters
- Petah Tikva, Israel
- Company type
- Public company
- Number of employees
- 10–80
Last updated
Latest news about PolyPid
In short: PolyPid initiated a rolling NDA submission to the FDA for D-PLEX100 and reported its Q1 2026 financial results.
Company announcements
PolyPid reports Q1 2026 results and updates on NDA submission
Initiated rolling NDA submission for D-PLEX100 to FDA, advanced EU regulatory preparation, and reported net loss of $7.7 million. Cash and equivalents totaled $10.9 million.
PolyPid initiates NDA submission to FDA for D-PLEX100
The rolling submission includes CMC and nonclinical modules, with completion expected in Q2 2026.
PolyPid receives PDUFA fee waiver from FDA for D-PLEX100
The $4.3M waiver enables focus on commercialization; NDA submission initiation is on track for March.
Media coverage
PolyPid Completes New Drug Application Submission to FDA for D-PLEX₁₀₀
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...
PolyPid Ltd. Q4 2025 Earnings Call Summary
PolyPid Ltd. Q4 2025 Earnings Call Summary - Moby Strategic Execution and Operational Evolution Successfully completed the SHIELD II Phase III trial for...
PolyPid Ltd.: PolyPid Completes New Drug Application Submission to FDA for D-PLEX100
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...
PolyPid Secures $26.7 Million Through Warrant Exercise Following Successful SHIELD II Phase 3 Trial Results
PolyPid Secures $26.7 Million Through Warrant Exercise Following Successful SHIELD II Phase 3 Trial Results...
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