PYPD PolyPid Ltd.
Price Chart
Executive Summary
PolyPid announced the initiation of a rolling New Drug Application (NDA) submission to the FDA for D-PLEX₁₀₀, its lead product candidate for preventing surgical site infections, under Fast Track and Breakthrough Therapy designations. The submission includes CMC and nonclinical modules, with clinical data to follow in Q2 2026, marking a pivotal regulatory milestone. The company is also advancing U.S. commercialization partnership discussions.
Actionable Insight
Traders should monitor upcoming clinical module submission in Q2 2026 and potential partnership announcement as catalysts. Given the Breakthrough Therapy Designation and strong Phase 3 data, approval prospects are enhanced, which could drive significant upside if a commercial partner is secured.
Key Facts
- PolyPid initiated a rolling NDA submission to the FDA for D-PLEX₁₀₀ for the prevention of surgical site infections in colorectal surgery patients.
- The NDA is being submitted under Fast Track designation and includes Chemistry, Manufacturing and Controls (CMC) and nonclinical sections.
- Clinical data module expected to be submitted in Q2 2026, with full submission completion anticipated in the same quarter.
- D-PLEX₁₀₀ demonstrated a 60% relative risk reduction in SSIs (p=0.0013) in the Phase 3 SHIELD II trial.
- The product has both Fast Track and Breakthrough Therapy Designations from the FDA.
- U.S. commercialization partnership negotiations are ongoing.
Financial Impact
Potential near-term value inflection pending FDA review; no direct financials reported but regulatory progress de-risks development path
Risk Factors
- FDA may require additional data or raise concerns during review, delaying approval.
- Failure to secure a U.S. commercialization partner could limit revenue potential.
- As a pre-revenue biopharma company, valuation is highly dependent on regulatory outcomes and partnership deals.
Market Snapshot
Documents Analyzed
This report is based on 1 press release from GlobeNewswire.
| Document | Accession Number |
|---|---|
| PRESS-RELEASE Data (Synthetic) | press-3265508 |
Filters
| Type | Now | ||||
|---|---|---|---|---|---|
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Jun 1, 2026
8d ago
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6-K
| $5.07 $4.50 | ▼ −11.24% | ▼ −8.49% | $4.57 (−9.86%) |
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Jun 1, 2026
8d ago
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Press Release
| $5.07 $4.50 | ▼ −11.24% | ▼ −8.49% | $4.57 (−9.86%) |
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May 20, 2026
20d ago
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Press Release
| $4.85 $4.77 | ▼ −1.65% | ▼ −2.89% | $4.57 (−5.77%) |
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May 13, 2026
27d ago
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6-K
| $4.22 $4.76 | ▲ +12.80% | ▲ +13.95% | $4.57 (+8.29%) |
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May 13, 2026
27d ago
|
Press Release
| $4.22 $4.76 | ▲ +12.80% | ▲ +13.95% | $4.57 (+8.29%) |
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Apr 13, 2026
8w ago
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Press Release
| $4.40 $4.69 | ▲ +6.59% | ▲ +3.30% | $4.57 (+3.86%) |
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Apr 6, 2026
9w ago
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3
| $4.24 $4.40 | ▲ +3.77% | ▼ −0.36% | $4.57 (+7.78%) |
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Mar 31, 2026
10w ago
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6-K
| $4.38 $4.23 | ▼ −3.42% | ▼ −7.37% | $4.57 (+4.34%) |
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Mar 31, 2026
10w ago
|
Press Release
| $4.38 $4.23 | ▼ −3.42% | ▼ −7.37% | $4.57 (+4.34%) |
US Market Status
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