Monitor the ESID 2026 presentation (Oct 14-17) for additional data, and watch for Q4 2026 topline results from the CVID Phase II trial, which will inform potential registrational study plans and market expansion.
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Executive Summary
Pharming announced positive Phase II topline data for leniolisib in primary immunodeficiencies (PIDs) with immune dysregulation, accepted as a late-breaking abstract at ESID 2026. The single-arm, open-label study in 13 patients showed a mean 26.4% spleen volume reduction and no new safety signals. Separately, topline results from a Phase II trial of leniolisib in CVID are expected in Q4 2026.
Key Facts
- Positive Phase II topline data for leniolisib in PIDs with immune dysregulation accepted as late-breaking abstract at ESID 2026
- Mean 26.4% spleen volume reduction (SVR) observed in 13-subject single-arm, open-label study
- No new safety signals identified; safety profile consistent with known leniolisib profile
- Topline results from separate Phase II trial of leniolisib in CVID expected in Q4 2026
- Leniolisib is already approved for APDS in multiple regions including U.S., EU, Japan
Financial Impact
No financial figures provided in the filing. The positive data supports pipeline expansion into broader PID populations beyond APDS, potentially expanding the addressable market for leniolisib.
Risk Factors
- Small sample size (n=13) limits statistical robustness of Phase II data
- Leniolisib safety and efficacy not yet established for PIDs beyond APDS
- CVID Phase II results still pending; registrational path uncertain
Investment Themes
Documents Analyzed
This report is based on 4 SEC documents filed with EDGAR.
| Document | Accession Number |
|---|---|
| 6-K Filing (Primary) | 0001828316-26-000039 |
| Document: 0001828316-26-000039-index-headers.html | 0001828316-26-000039 |
| Document: 0001828316-26-000039-index.html | 0001828316-26-000039 |
| Document: 0001828316-26-000039.txt | 0001828316-26-000039 |
Filters
| Type | Now | ||||
|---|---|---|---|---|---|
Oct 27, 2026 today | 6-K | $11.55 | awaiting T+1 | — | $11.87 (+2.77%) |
Oct 27, 2026 today | Press Release | $11.55 | awaiting T+1 | — | $11.87 (+2.77%) |
Oct 22, 2026 5d ago | 6-K | $10.67 $11.20 | ▲ +4.97% | ▲ +5.49% | $11.87 (+11.25%) |
Oct 14, 2026 13d ago | 6-K | $9.64 $9.63 | ▼ −0.10% | ▼ −0.39% | $11.87 (+23.13%) |
Sep 29, 2026 28d ago | 6-K | $10.01 $9.99 | ▲ +0.20% | ▼ −0.01% | $11.87 (−18.58%) |
Sep 29, 2026 28d ago | Press Release | $10.01 $9.99 | ▲ +0.20% | ▼ −0.01% | $11.87 (−18.58%) |
Sep 25, 2026 4w ago | 6-K | $10.46 $10.52 | ▲ +0.57% | ▲ +1.32% | $11.87 (+13.48%) |
Sep 25, 2026 4w ago | Press Release | $10.46 $10.52 | ▲ +0.57% | ▲ +1.32% | $11.87 (+13.48%) |
Sep 22, 2026 5w ago | 6-K | $11.26 $10.77 | ▼ −4.35% | ▼ −3.63% | $11.87 (+5.42%) |
Sep 11, 2026 6w ago | 6-K | $11.21 $10.82 | ▼ −3.48% | ▼ −3.03% | $11.87 (+5.89%) |
US Market Status
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