Rezolute FY2026 Results: upLIFT Interim Data Shows 7 of 8 Responders; sunRIZE Still Under FDA Review
RZLT has more than doubled off its 52-week low of $1.07 on elevated volume (2.5× avg).
Summary
Rezolute reported FY2026 results and updated its two Phase 3 programs: upLIFT interim data shows 7 of 8 tumor HI participants met the primary endpoint, while sunRIZE in congenital HI remains under FDA review after missing its primary endpoint.
Key Events · Earnings and Guidance · RZLT
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upLIFT Interim Data: 7 of 8 Responders
In the Phase 3 upLIFT study for tumor HI, 7 of 8 enrolled participants have now met the primary endpoint responder criterion. The eighth participant withdrew consent for hospice care and is counted as a non-responder.
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sunRIZE Remains Under FDA Review
The Phase 3 sunRIZE study in congenital HI, which did not meet its primary endpoint, remains under FDA review. Rezolute submitted additional CGM-based analyses in June 2026 and may request a formal regulatory meeting.
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FY2026 Financial Results
Full-year net loss was $77.6 million, with R&D expenses of $53.8 million and G&A of $29.2 million. Cash and investments totaled $107.8 million as of June 30, 2026, down from $167.9 million a year earlier.
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Topline upLIFT Data Expected Before End of 2026
Enrollment in upLIFT is ongoing, and topline results are expected before the end of 2026.
Analysis · RZLT · Life Sciences
The fiscal 2026 earnings release from Rezolute carries two clinical updates that matter more than the financials. In the upLIFT Phase 3 study for tumor HI, 7 of 8 enrolled participants have now met the primary endpoint responder criterion; the eighth withdrew consent for hospice care and is counted as a non-responder. Separately, the sunRIZE Phase 3 study in congenital HI — which previously missed its primary endpoint — remains under FDA review, with the company having submitted additional CGM-based analyses in June 2026. Cash and investments stand at $107.8 million, down from $167.9 million a year earlier, providing runway while the company awaits regulatory feedback.
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In the 30 days to Sep 30, 2026, 29.5% of the 1626 measured filings Wiseek scored 7 moved their stock by 5% or more by the next session's close. The median move was -0.57%. These are measured outcomes after filings of this importance, not a forecast for this one.
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At the time of this filing, RZLT was trading at $3.94 on NASDAQ in the Life Sciences sector, with a market capitalization of approximately $379.4M. The 52-week trading range was $1.07 to $11.46. This filing was assessed with neutral market sentiment and an importance score of 7 out of 10.