Rezolute's lead Phase 3 trial fails; FDA review ongoing, workforce cut 40%

Filed May 12, 2026 · Period ending March 31, 2026 · Compared to 10-Q May 13, 2025 · ~2 min read

Key Changes

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  sunRIZE Phase 3 study for congenital hyperinsulinism missed primary and key secondary endpoints in December 2025; FDA requested comprehensive datasets for independent review with no commitment to accept existing data for approval.

  MD&A: sunRIZE Phase 3 study failure verify on EDGAR →
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  Company reduced workforce by 29 employees (approximately 40%) in December 2025 following trial failure, incurring $1.5 million in severance costs to conserve cash.

  MD&A: Workforce reduction verify on EDGAR →
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  upLIFT Phase 3 trial for tumor hyperinsulinism expected to complete enrollment and report topline results in second half of 2026; FDA allowed design modifications removing placebo-controlled requirement, but efficacy demonstration remains uncertain.

  MD&A: upLIFT study timeline / Risk Factors: upLIFT trial design verify on EDGAR →