This NDA completion is a major catalyst milestone. With Breakthrough Therapy and QIDP designations, Priority Review is likely and regulatory probability is elevated. Traders should position ahead of the Q1 2027 PDUFA date; monitor for Priority Review grant and commercial partnership announcements as near-term catalysts.
Price Chart
Executive Summary
PolyPid completed its rolling NDA submission to the FDA for D-PLEX100 to prevent surgical site infections in colorectal surgery. The filing is supported by a Phase 3 trial with a 60% relative risk reduction (p=0.0013), and the drug has Breakthrough Therapy, Fast Track, and QIDP designations. The PDUFA target date is Q1 2027, with potential Priority Review.
Key Facts
- NDA submission completed for D-PLEX100 to prevent surgical site infections in colorectal surgery.
- Phase 3 SHIELD II trial achieved primary endpoint with 60% relative risk reduction (p=0.0013).
- D-PLEX100 has Breakthrough Therapy, Fast Track, and QIDP designations, supporting Priority Review eligibility.
- PDUFA target action date expected in Q1 2027.
- Company is finalizing U.S. commercial partnership discussions for potential launch.
Financial Impact
Not disclosed; $90M market cap pre-filing. Approval could transform the company's valuation — early-stage biotech approvals produce 8-15% CAR in the literature. Positive Phase 3 results with 60% RRR suggest high probability of approval given regulatory designations.
Risk Factors
- FDA could issue a Complete Response Letter (CRL) despite positive data, particularly on CMC or manufacturing grounds.
- Commercial adoption and reimbursement are uncertain even if approved.
- Company has relatively small market cap ($90M) and may need additional capital for launch.
Market Snapshot
Investment Themes
Documents Analyzed
This report is based on 1 press release from GlobeNewswire.
| Document | Accession Number |
|---|---|
| PRESS-RELEASE Data (Synthetic) | press-3304355 |
Filters
| Type | Now | ||||
|---|---|---|---|---|---|
Oct 15, 2026 11d ago | Press Release | $4.90 | awaiting T+60 | — | $5.29 (+7.96%) |
Oct 1, 2026 25d ago | 6-K | $5.37 | awaiting T+60 | — | $5.29 (−1.49%) |
Oct 1, 2026 25d ago | Press Release | $5.37 | awaiting T+60 | — | $5.29 (−1.49%) |
Oct 1, 2026 25d ago | 6-K | $5.37 | awaiting T+60 | — | $5.29 (−1.49%) |
Oct 1, 2026 25d ago | Press Release | $5.37 | awaiting T+60 | — | $5.29 (−1.49%) |
Aug 12, 2026 10w ago | 6-K | $4.78 | awaiting T+60 | — | $5.29 (+10.67%) |
Aug 12, 2026 10w ago | 6-K | $4.84 | awaiting T+60 | — | $5.29 (+9.30%) |
Aug 12, 2026 10w ago | Press Release | $4.84 | awaiting T+60 | — | $5.29 (+9.30%) |
Jul 29, 2026 12w ago | 6-K | $4.08 $5.13 | ▲ +25.74% | ▲ +21.01% | $5.29 (+29.66%) |
Jul 21, 2026 13w ago | 6-K | $3.74 $4.83 | ▲ +29.14% | ▲ +26.30% | $5.29 (+41.44%) |
US Market Status
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