PolyPid completes NDA submission to FDA for D-PLEX100
The submission aims to prevent surgical site infections; PDUFA target in Q1 2027.
See the latest news and media coverage for PolyPid. We track all announcements, press releases, and industry mentions in real time, all in one place.
Developer of long-acting controlled-release medicines
polypid.comLast updated
In short: PolyPid completed its NDA submission to the FDA for D-PLEX100 and advanced clinical data presentations following positive Phase 3 results.
The submission aims to prevent surgical site infections; PDUFA target in Q1 2027.
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.
The rolling submission includes CMC and nonclinical modules, with completion expected in Q2 2026.
The $4.3M waiver enables focus on commercialization; NDA submission initiation is on track for March.
PETACH TIKVA, Israel, April 06, 2022 (GLOBE NEWSWIRE) -- PolyPid Ltd. (Nasdaq: PYPD) (“PolyPid” or the “Company”), a late-stage biopharma company aiming to improve surgical...
A May 2026 Big Pharma acquisition just validated the surgical site infection prevention market at the highest possible level. PolyPid (NASDAQ:PYPD) recently completed its NDA...
Discover high-conviction stock picks and new investing opportunities with the TipRanks Smart Investor Newsletter PolyPid ( (PYPD)) just unveiled an update. On June 1, 2026...
PolyPid Ltd. Q4 2025 Earnings Call Summary - Moby Strategic Execution and Operational Evolution Successfully completed the SHIELD II Phase III trial for...
Track PolyPid and your other target companies to get real-time alerts and weekly summaries delivered straight to your inbox.
Browse news for competitors to PolyPid and other trending companies.