With both EMA validation and FDA Priority Review underway, the next binary catalyst is the November 28, 2026 PDUFA date. Monitor for any AdCom scheduling or FDA briefing documents ahead of the decision.
Price Chart
Executive Summary
PolyPid announced that the EMA has validated its MAA for D-PLEX100, initiating formal regulatory review for EU approval. The NDA is concurrently under FDA Priority Review with a PDUFA date of November 28, 2026. This dual-regulatory progress de-risks the asset and opens a significant European market opportunity for the prevention of surgical site infections.
Key Facts
- EMA validated PolyPid's MAA for D-PLEX100 on September 14, 2026, initiating formal CHMP review under the Centralized Procedure.
- FDA accepted the NDA for D-PLEX100 with Priority Review and a PDUFA goal date of November 28, 2026.
- Phase 3 SHIELD II trial met primary endpoint and showed 60% relative risk reduction in SSIs vs standard of care (p=0.0013).
- If approved, D-PLEX100 would receive a single marketing authorization valid throughout all EU member states.
- PolyPid retains commercial rights to D-PLEX100 outside the U.S. and Canada; Azurity Pharmaceuticals holds rights in U.S. and Canada.
Financial Impact
No financial figures disclosed; potential EU market access for SSI prevention represents a multi-hundred-million-dollar opportunity if approved.
Risk Factors
- Regulatory non-approval or delays from either EMA or FDA could materially impact the stock.
- Commercial adoption and reimbursement in EU member states are uncertain even if approved.
- Competing SSI prevention products may limit market share.
Investment Themes
Documents Analyzed
This report is based on 1 press release from GlobeNewswire.
| Document | Accession Number |
|---|---|
| PRESS-RELEASE Data (Synthetic) | press-3373005 |
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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