Traders should position for the PDUFA catalyst on November 28, 2026 — Priority Review increases the probability of approval and the $15M milestone de-risks near-term financing. Monitor for any FDA advisory committee meeting announcement and watch for potential pre-approval manufacturing or partnership updates. The stock is likely to trade on binary approval risk over the next four months.
Price Chart
Executive Summary
PolyPid announced FDA acceptance of its NDA for D-PLEX100 with Priority Review, setting an accelerated PDUFA target action date of November 28, 2026. The acceptance triggers a $15 million milestone payment from Azurity Pharmaceuticals, completing $30M in upfront and near-term milestone payments. This regulatory milestone de-risks the company's lead asset and provides non-dilutive capital, positioning for a potential U.S. commercial launch in early 2027 if approved.
Key Facts
- FDA accepted NDA for D-PLEX100 with Priority Review for prevention of surgical site infections in abdominal colorectal surgery
- PDUFA target action date set for November 28, 2026, approximately one quarter ahead of prior Q1 2027 guidance
- No filing review issues identified by the FDA
- Acceptance triggers a $15 million milestone payment from Azurity Pharmaceuticals, completing $30M in upfront and near-term milestone payments under the July 17, 2026 partnership
Financial Impact
Acceptance triggers a $15 million milestone payment, completing $30 million in upfront and near-term payments from Azurity; this represents ~21% of the company's $72M market cap and provides non-dilutive capital
Risk Factors
- FDA may not approve D-PLEX100 despite Priority Review — the review outcome remains binary
- Competitive landscape: existing SSI prevention products and pipeline candidates could limit market uptake
- The company remains pre-revenue and will require additional capital beyond the Azurity milestone if approval is delayed or launch costs exceed expectations
Market Snapshot
Investment Themes
Documents Analyzed
This report is based on 5 SEC documents filed with EDGAR.
| Document | Accession Number |
|---|---|
| 6-K Filing (Primary) | 0001213900-26-082564 |
| Document: ea0299642-6k_polypid.htm | 0001213900-26-082564 |
| Document: 0001213900-26-082564-index-headers.html | 0001213900-26-082564 |
| Document: 0001213900-26-082564-index.html | 0001213900-26-082564 |
| Document: 0001213900-26-082564.txt | 0001213900-26-082564 |
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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