PolyPid's lead product candidate D-PLEX 100 is in Phase 3 clinical trial for the prevention of abdominal colorectal surgical site infections. In March 2026, PolyPid submitted first modules as part of a rolling NDA review, with completion expected in Q2 2026, and received a $4.3 million FDA Small Business Waiver to enable focus on commercialization preparations.
Cyborg Score Rationale
As of September 2024, PolyPid faced stockholders' equity non-compliance with Nasdaq, reporting approximately $2.158 million against the $2.5 million minimum requirement. However, the company has advanced its lead candidate toward regulatory submission with recent positive clinical data from April 2026.
Top Insights
NDA rolling submission initiated in March 2026 with expected completion in Q2 2026 for D-PLEX100 surgical site infection prevention.
Company operates a focused biotech model built around proprietary delivery technology for locally administered therapies addressing post-surgical infections and oncology indications.
Stockholders' equity fell below Nasdaq minimums as of November 2024, creating listing compliance risk.
Preclinical OncoPLEX program underway for solid tumor treatment, beginning with glioblastoma.
Named Competitors
Surgical Site Infection Prevention Products — Healthcare supplier with infection control solutions
Antibiotic Prophylaxis Solutions — Intravenous antibiotic delivery for surgical prophylaxis
Controlled-Release Drug Delivery — Proprietary delivery technologies for localized therapeutics
Recent Developments
(May 2026) Company announced Q1 2026 financial results reporting