When did Oryzon Genomics, S.A. announce the EMA authorisation for the IDEAL study?

Oryzon Genomics, S.A. made the announcement on February 24, 2026. The announcement concerns the authorisation to initiate the IDEAL Phase II study of iadademstat in essential thrombocythemia.

What is the IDEAL study that Oryzon Genomics, S.A. plans to conduct?

IDEAL is a multicenter, single-arm Phase II study of iadademstat in adult patients with essential thrombocythemia who are resistant or intolerant to hydroxyurea. The study is to be conducted in Spain.

What are the primary objectives of Oryzon Genomics, S.A.'s IDEAL study?

The primary objectives are to evaluate the safety and tolerability of iadademstat and assess its efficacy in reducing the percentage of adult ET patients with abnormal platelet counts.

How long will patients receive iadademstat in Oryzon Genomics, S.A.'s IDEAL study?

Iadademstat will be administered for up to 24 weeks in the IDEAL study. An additional 24-week extension phase will be available to patients who are benefiting from treatment and who, in agreement with their physician, elect to continue.

Why is Oryzon Genomics, S.A. studying iadademstat in essential thrombocythemia?

The company said that a significant proportion of patients develop resistance or intolerance to first-line treatments such as hydroxyurea, creating a need for additional therapeutic approaches. Oryzon also said LSD1 inhibition has been shown to block the terminal differentiation of megakaryocytes into platelets, leading to a steady reduction in circulating platelet counts.

What does Oryzon Genomics, S.A. say about the potential role of iadademstat in ET and other myeloproliferative diseases?

CEO Dr Carlos Buesa said the IDEAL study broadens iadademstat's clinical development beyond acute leukaemia into additional haematologic indications and that the company believes LSD1 inhibition could address the underlying biology of essential thrombocythemia. Dr Ana Limón said the study will also explore whether iadademstat could affect disease progression, while the source presents this as potential rather than an established outcome.

What is essential thrombocythemia and how large is the affected population described by Oryzon Genomics, S.A.?

Essential thrombocythemia is described as the most common type of myeloproliferative neoplasm and is associated with an increased risk of complications including stroke, heart attack and pulmonary embolism. The source says the disease affects approximately 200,000 people in the United States.

What other clinical studies of iadademstat is Oryzon Genomics, S.A. conducting?

Iadademstat is being investigated in the Phase Ib ALICE-2 study with venetoclax and azacitidine in first-line AML, the company-sponsored FRIDA trial with gilteritinib in relapsed or refractory FLT3-mutated AML, and studies under a Cooperative Research and Development Agreement with the U.S. National Cancer Institute. The company also reports investigator-initiated studies in myelodysplastic syndrome and small cell lung cancer, as well as a clinical trial in sickle cell disease.

What preliminary results has Oryzon Genomics, S.A. reported for iadademstat?

Oryzon Genomics, S.A. said preliminary data from the ALICE-2 study presented at the American Society of Hematology 2025 annual meeting showed a 100% overall response rate (ORR) and a 90% strict complete remission (CR) rate. The company also said preliminary positive data from the FRIDA trial were presented at ASH-2025.

What does Oryzon Genomics, S.A. do and how is it identified in the announcement?

Oryzon Genomics, S.A. describes itself as a clinical-stage biopharmaceutical company and a global leader in epigenetics, with iadademstat in clinical development in oncology and hematology. The announcement gives ISIN Code: ES0167733015 and Ticker: ORY.

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Oryzon receives EMA authorisation to begin Phase II iadademstat study in essential thrombocythemia

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Oryzon Genomics S.A.

BME:ORY
OTC PINK:ORYZF

Oryzon receives EMA authorisation to begin Phase II iadademstat study in essential thrombocythemia

Q: What secondary objectives will Oryzon Genomics, S.A. assess in the IDEAL study?

The secondary objectives include assessing the durable clinical hematologic response (DCHR) rate, confirming iadademstat's pharmacokinetic and pharmacodynamic profile in ET patients, and evaluating the duration of hematologic remissions (DHRs).

Published Tuesday, 24 February 2026

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At a glance

Company: Oryzon Genomics S.A.
Listings: BME:ORY, OTC PINK:ORYZF
Announcement type: Regulatory approval
Published: Tuesday, 24 February 2026
Source announcement: oryzon.com

Key figures
Measure	Figure
Overall response rate (ORR)	100%
Strict complete remission (CR) rate	90%
Extension phase	24-week

Figures are quoted from this announcement and selected automatically.

FAQSIR Generated from this announcement View original release below for safe harbor and regulatory notices

Announcement Summary

Oryzon Genomics, S.A. (Ticker: ORY) announced regulatory authorization for a Phase II clinical study of iadademstat to treat essential thrombocythemia.

The announcement is dated February 24, 2026; the European Medicines Agency authorized Oryzon’s Clinical Trial Application (CTA) to initiate the study.
The IDEAL study is a multicenter, single-arm study to be conducted in Spain among adults with ET resistant or intolerant to hydroxyurea.
Primary objectives are evaluating safety and tolerability, and assessing efficacy by reducing abnormal platelet counts in adult ET patients.
Iadademstat will be administered for up to 24 weeks; patients benefiting from treatment may elect an additional 24-week extension with physician agreement.

Secondary objectives include the durable clinical hematologic response (DCHR) rate, confirming iadademstat’s pharmacokinetic and pharmacodynamic profile, and evaluating the duration of hematologic remissions.

Investor FAQs

Oryzon Genomics, S.A. announced that the European Medicines Agency (EMA) had authorised its Clinical Trial Application (CTA) to initiate a Phase II study of iadademstat in essential thrombocythemia (ET). The IDEAL study will evaluate the treatment in adult patients with ET who are resistant or intolerant to hydroxyurea.

Source announcement

Company: Oryzon Genomics S.A.
Title: ORYZON receives European Medicines Agency approval to initiate a Phase II study of iadademstat in essential thrombocythemia
Published: Tuesday, 24 February 2026
Source site: oryzon.com

Read the source announcement on oryzon.com

FAQSIR's summary and investor FAQs are generated by AI from the text of this announcement alone, without information from other sources.

Figures, forecasts and other claims are the announcement's, not FAQSIR's. FAQSIR does not independently verify them.

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