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.
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.
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
Investment Themes
Documents Analyzed
This report is based on 1 press release from GlobeNewswire.
| Document | Accession Number |
|---|---|
| PRESS-RELEASE Data (Synthetic) | press-3265508 |
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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