PYPD PolyPid Ltd.
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.
Actionable Insight
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.
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
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 | ||||
|---|---|---|---|---|---|
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Jun 1, 2026
5d ago
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6-K
| $5.07 $4.87 | ▼ −3.94% | ▼ −4.09% | $4.50 (−11.24%) |
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Jun 1, 2026
5d ago
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Press Release
| $5.07 $4.87 | ▼ −3.94% | ▼ −4.09% | $4.50 (−11.24%) |
|
May 20, 2026
17d ago
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Press Release
| $4.85 $4.83 | ▼ −0.41% | ▼ −0.61% | $4.50 (−7.22%) |
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May 13, 2026
24d ago
|
6-K
| $4.22 $4.38 | ▲ +3.79% | ▲ +3.01% | $4.50 (+6.64%) |
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May 13, 2026
24d ago
|
Press Release
| $4.22 $4.38 | ▲ +3.79% | ▲ +3.01% | $4.50 (+6.64%) |
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Apr 13, 2026
7w ago
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Press Release
| $4.40 $4.42 | ▲ +0.45% | ▼ −0.76% | $4.50 (+2.27%) |
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Apr 6, 2026
8w ago
|
3
| $4.24 $4.12 | ▼ −2.83% | ▼ −2.89% | $4.50 (+6.13%) |
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Mar 31, 2026
9w ago
|
6-K
| $4.38 $4.39 | ▲ +0.23% | ▼ −0.52% | $4.50 (+2.74%) |
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Mar 31, 2026
9w ago
|
Press Release
| $4.38 $4.39 | ▲ +0.23% | ▼ −0.52% | $4.50 (+2.74%) |
US Market Status
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