RegulatoryMay 13, 2026, 07:32 AM
PolyPid Initiates D-PLEX₁₀₀ NDA Submission; US Partnership in Late Stages
AI Summary
PolyPid initiated its New Drug Application (NDA) submission to the FDA for D-PLEX₁₀₀ for preventing surgical site infections, with completion expected imminently. The company also reported late-stage discussions for a U.S. commercial partnership and scheduled meetings with the EMA for a Marketing Authorization Application (MAA) in Q2 2026. New Phase 3 data showed a 64% relative risk reduction in wound infection severity. For Q1 2026, PolyPid reported a net loss of $7.7 million, or ($0.35) per share, an improvement from $8.3 million, or ($0.70) per share, in Q1 2025. The company also repaid its remaining venture loan and strengthened its cash position through warrant exercises.
Key Highlights
- Initiated D-PLEX₁₀₀ NDA submission to FDA on March 30, 2026, with completion expected imminently.
- FDA granted a PDUFA fee waiver of approximately $4.3 million for the D-PLEX₁₀₀ NDA.
- U.S. commercial partnership discussions for D-PLEX₁₀₀ are in late stages.
- Scheduled EMA meetings in Q2 2026 for D-PLEX₁₀₀ MAA, with submission planned for Q3 2026.
- New SHIELD II Phase 3 data showed 64% relative risk reduction in wound infection severity.
- Q1 2026 net loss was $7.7 million ($0.35/share), an improvement from $8.3 million ($0.70/share) in Q1 2025.
- Cash, cash equivalents, and short-term deposits totaled $10.9 million as of March 31, 2026.
- Repaid remaining $0.8 million venture loan facility and generated $4.0 million from warrant exercises.