PYPD PolyPid Ltd.
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.
Actionable Insight
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.
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
Documents Analyzed
This report is based on 1 press release from GlobeNewswire.
| Document | Accession Number |
|---|---|
| PRESS-RELEASE Data (Synthetic) | press-3304355 |
Filters
| Type | Now | ||||
|---|---|---|---|---|---|
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Jun 10, 2026
2d ago
|
6-K
| $4.52 awaiting T+5 | awaiting T+5 | — | $4.62 (+2.21%) |
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Jun 1, 2026
11d ago
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6-K
| $5.07 $4.50 | ▼ −11.24% | ▼ −8.49% | $4.62 (−8.88%) |
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Jun 1, 2026
11d ago
|
Press Release
| $5.07 $4.50 | ▼ −11.24% | ▼ −8.49% | $4.62 (−8.88%) |
|
May 20, 2026
23d ago
|
Press Release
| $4.85 $4.77 | ▼ −1.65% | ▼ −2.89% | $4.62 (−4.74%) |
|
May 13, 2026
4w ago
|
6-K
| $4.22 $4.76 | ▲ +12.80% | ▲ +13.95% | $4.62 (+9.48%) |
|
May 13, 2026
4w ago
|
Press Release
| $4.22 $4.76 | ▲ +12.80% | ▲ +13.95% | $4.62 (+9.48%) |
|
Apr 13, 2026
8w ago
|
Press Release
| $4.40 $4.69 | ▲ +6.59% | ▲ +3.30% | $4.62 (+5.00%) |
|
Apr 6, 2026
9w ago
|
3
| $4.24 $4.40 | ▲ +3.77% | ▼ −0.36% | $4.62 (+8.96%) |
|
Mar 31, 2026
10w ago
|
6-K
| $4.38 $4.23 | ▼ −3.42% | ▼ −7.37% | $4.62 (+5.48%) |
|
Mar 31, 2026
10w ago
|
Press Release
| $4.38 $4.23 | ▼ −3.42% | ▼ −7.37% | $4.62 (+5.48%) |
US Market Status
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