Oryzon Genomics, S.A. (ORY) Gets Spain Approval for AML Study

What happened

Spain authorized VIVALDI, a Phase Ib pilot study sponsored by CETLAM, testing iadademstat with azacitidine and venetoclax in newly diagnosed AML subgroups with suboptimal responses to standard care. Oryzon plans to start ALICE-3, a potentially registrational Phase III study, in 2027.

Confirmed

Global impact / market context

The Spain approval lets a combination study proceed, adding clinical evidence for iadademstat in AML. Investors should focus on whether this supports the later ALICE-3 trial, whose 2027 start depends on regulatory agreement and financing, so cash needs and trial costs matter.

Analyst inference

This is an early-stage study update, not efficacy data, so it does not yet prove the combination works. The nearer catalysts are VIVALDI progress and final ALICE-2 data expected at the 2026 ASH meeting, which may shape the design and financing case for ALICE-3.

Analyst inference

What to watch

1. Spain authorized the VIVALDI Phase Ib study testing iadademstat with azacitidine and venetoclax in newly diagnosed AML subgroups with suboptimal responses to standard care, but no efficacy results were reported. Confirmed
2. Oryzon plans to start the potentially registrational ALICE-3 Phase III study in 2027, subject to regulatory agreement and financing, and final ALICE-2 data are expected at the 2026 ASH meeting. Confirmed
3. Watch whether regulatory discussions and financing allow ALICE-3 to begin as planned, and whether VIVALDI or ALICE-2 results support the combination, since delays or weak data could raise costs and cash needs. Analyst inference

Evidence

• globenewswire.com