The November 28, 2026 PDUFA date is the primary catalyst — a positive FDA decision could trigger a significant re-rating given the $90M market cap and $320M milestone potential. Monitor for any FDA advisory committee meeting announcement and the upcoming MAA submission to the EMA in Q3 2026.
Price Chart
Executive Summary
PolyPid reported Q2 2026 EPS of -$0.35, beating consensus of -$0.38 by 7.3%, with no revenue. The key catalyst is the FDA's acceptance of the D-PLEX₁₀₀ NDA with Priority Review and a PDUFA date of November 28, 2026, alongside a $30M upfront payment from the Azurity partnership, strengthening the balance sheet to $6.6M cash plus the milestone proceeds. This filing is bullish due to the accelerated regulatory timeline and de-risked commercialization path, though the company remains pre-revenue with no approved product.
Key Financial Metrics
Key Facts
- FDA accepted D-PLEX₁₀₀ NDA with Priority Review; PDUFA goal date November 28, 2026
- Exclusive U.S. and Canada commercialization partnership with Azurity Pharmaceuticals; $30M in upfront and near-term milestones achieved
- Phase 3 SHIELD II trial met primary endpoint with 60% relative risk reduction in SSIs (p=0.0013)
- Q2 2026 EPS -$0.35 beat consensus -$0.38 by 7.3%; net loss $7.8M vs $10.0M in Q2 2025
- Cash and cash equivalents $6.6M as of June 30, 2026, plus $30M from Azurity; management expects funding into 2028
Financial Impact
EPS beat of $0.03 vs consensus; $30M in upfront and near-term milestone payments from Azurity; up to $320M total milestones plus tiered royalties up to mid-twenties percentages
Risk Factors
- FDA may not approve D-PLEX₁₀₀ by the PDUFA date or may require additional trials
- Commercial launch success depends on Azurity's execution and market adoption of a new SSI prevention product
- Pre-revenue company with $6.6M cash (pre-Azurity) and ongoing operating losses; dilution risk if milestones are delayed
Market Snapshot
Investment Themes
Documents Analyzed
This report is based on 1 press release from GlobeNewswire.
| Document | Accession Number |
|---|---|
| PRESS-RELEASE Data (Synthetic) | press-3343550 |
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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