This is a binary catalyst event — the stock will likely re-rate on the probability of FDA approval. Traders should monitor for Priority Review acceptance (60-day filing review) and any commercial partnership announcements, which could provide near-term upside. The PDUFA date in Q1 2027 sets a clear timeline for the next major catalyst.
Price Chart
Executive Summary
PolyPid completed its NDA submission to the FDA for D-PLEX100, its lead product candidate for preventing surgical site infections in colorectal surgery. The filing is a major regulatory milestone, with a PDUFA target action date in Q1 2027, supported by Phase 3 data showing a 60% relative risk reduction. This de-risks the path to potential approval and commercial launch, though the outcome remains binary pending FDA review.
Key Facts
- NDA submission completed on a rolling review basis to the FDA for D-PLEX100
- PDUFA target action date planned for Q1 2027
- Phase 3 SHIELD II trial met primary endpoint with 60% relative risk reduction in SSIs (p=0.0013)
- D-PLEX100 has Breakthrough Therapy, Fast Track, and QIDP designations, supporting Priority Review eligibility
- Company is finalizing U.S. commercial partnership discussions and preparing for potential launch
Financial Impact
No financial figures provided; potential approval could unlock a multi-hundred-million-dollar SSI prevention market, but no revenue or deal values disclosed.
Risk Factors
- FDA may issue a Complete Response Letter (CRL) or request additional data, delaying or denying approval
- No revenue or cash position disclosed; the company may need to raise capital before launch
- Commercial execution risk if approved, given the need for a sales infrastructure or partnership
Market Snapshot
Investment Themes
Documents Analyzed
This report is based on 5 SEC documents filed with EDGAR.
| Document | Accession Number |
|---|---|
| 6-K Filing (Primary) | 0001213900-26-063169 |
| Document: ea0292882-6k_polypid.htm | 0001213900-26-063169 |
| Document: 0001213900-26-063169-index-headers.html | 0001213900-26-063169 |
| Document: 0001213900-26-063169-index.html | 0001213900-26-063169 |
| Document: 0001213900-26-063169.txt | 0001213900-26-063169 |
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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