Topline data in mid-December 2026 is the key binary catalyst. The interim readout showing 7/8 responders (87.5%) already exceeds the 56% threshold for statistical significance, but the full 16-patient dataset will determine whether the lower bound of the 95% CI clears 30%. Monitor for any safety signals in the second half of enrollment.
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Executive Summary
Rezolute announced completion of enrollment in its Phase 3 upLIFT study of ersodetug for tumor hyperinsulinism, with topline data expected mid-December 2026. Earlier interim data showed 7 of 8 first-half participants met the primary endpoint, all achieving complete discontinuation of IV glucose. The filing is a routine operational update with no financial data.
Key Facts
- Phase 3 upLIFT study fully enrolled (16 participants) for ersodetug in tumor hyperinsulinism
- Topline data expected mid-December 2026
- Earlier interim results: 7 of 8 first-half participants met primary endpoint (≥50% reduction in glucose infusion rate)
- All 7 responders achieved complete discontinuation of intravenous glucose
- No drug-related safety findings reported to date
- One participant died due to cancer progression, classified as non-responder
- Statistical significance requires ≥56% responder rate (lower bound of 95% CI ≥30%)
Financial Impact
No financial data provided in the filing
Risk Factors
- Topline results may fail to meet statistical significance threshold if second-half responders underperform
- Regulatory approval for ersodetug is not guaranteed even if study succeeds
- Small sample size (16 participants) amplifies outcome variability
Investment Themes
Documents Analyzed
This report is based on 5 SEC documents filed with EDGAR.
| Document | Accession Number |
|---|---|
| 8-K Filing (Primary) | 0001104659-26-115874 |
| Document: tm2627620d1_ex99-1.htm | 0001104659-26-115874 |
| Document: 0001104659-26-115874-index-headers.html | 0001104659-26-115874 |
| Document: 0001104659-26-115874-index.html | 0001104659-26-115874 |
| Document: 0001104659-26-115874.txt | 0001104659-26-115874 |
Filters
| Type | Now | ||||
|---|---|---|---|---|---|
Oct 21, 2026 5d ago | DEF 14A | $3.86 | awaiting T+20 | — | $3.82 (−1.04%) |
Oct 14, 2026 12d ago | 8-K | $3.90 | awaiting T+20 | — | $3.82 (−2.05%) |
Oct 5, 2026 21d ago | 8-K | $4.33 | awaiting T+20 | — | $3.82 (−11.78%) |
Sep 24, 2026 4w ago | 8-K | $3.90 $3.86 | ▲ +1.15% | ▼ −0.32% | $3.82 (+2.05%) |
Sep 24, 2026 4w ago | Press Release | $3.90 $3.86 | ▲ +1.15% | ▼ −0.32% | $3.82 (+2.05%) |
Jul 21, 2026 13w ago | Press Release | $5.09 $4.66 | ▼ −8.45% | ▼ −11.01% | $3.82 (−24.95%) |
Jun 11, 2026 19w ago | Institutional Cluster | $3.86 $5.13 | ▲ +32.90% | ▲ +31.01% | $3.82 (−1.04%) |
Jun 4, 2026 20w ago | Press Release | $4.51 $4.91 | ▲ +8.87% | ▲ +10.24% | $3.82 (−15.30%) |
Jun 2, 2026 20w ago | 8-K | $4.00 $4.95 | ▲ +23.75% | ▲ +25.32% | $3.82 (−4.50%) |
May 12, 2026 23w ago | 8-K | $3.33 $3.86 | ▲ +15.92% | ▲ +16.53% | $3.82 (+14.71%) |
US Market Status
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