ORYZON Reports Third Quarter 2026 Financial Results and Provides Corporate Update
Key Highlights
- ➤ALICE-2 95% ORR, 84% CRc, and 74% CR in first-line AML
- ➤FRIDA 67% CRc rate at recommended Phase 2 dose in relapsed/refractory AML
- ➤VIVALDI Phase Ib first-line AML study authorized in Spain
- ➤Cash totaled $21.7 million as of September 30, 2026
- ➤Nine-month R&D expenses rose to $16.0 million from $9.6 million
Expert Statements
Dr. Carlos Buesa, Chief Executive Officer of Oryzon
“Since our last results update, Oryzon has continued to build the clinical evidence needed to advance our key development programs.”
Dr. Carlos Buesa, Chief Executive Officer of Oryzon
“The three iadademstat abstracts accepted for ASH 2026 add to the growing body of clinical evidence supporting the activity of iadademstat across hematological malignancies.”
Dr. Carlos Buesa, Chief Executive Officer of Oryzon
“We are particularly encouraged by the high remission rates and promising survival results observed with iadademstat in combination with azacitidine and venetoclax in the Phase Ib ALICE-2 study in newly diagnosed AML.”
Dr. Carlos Buesa, Chief Executive Officer of Oryzon
“We look forward to presenting updated data at ASH in December.”
Dr. Carlos Buesa, Chief Executive Officer of Oryzon
“Building on the ALICE-2 findings, we are preparing to engage with the FDA on the design of ALICE-3, our planned potentially registrational Phase III trial in first-line AML.”
Dr. Carlos Buesa, Chief Executive Officer of Oryzon
“Our objective remains to initiate the study in 2027, subject to regulatory agreement and financing.”
Dr. Carlos Buesa, Chief Executive Officer of Oryzon
“Alongside our AML program, preliminary positive findings in accelerated/blast-phase myeloproliferative neoplasms and ongoing clinical evaluation in myelodysplastic syndromes are helping us explore the broader potential of iadademstat.”
Dr. Carlos Buesa, Chief Executive Officer of Oryzon
“In CNS, we continue to advance the clinical development of vafidemstat across several indications.”
Dr. Carlos Buesa, Chief Executive Officer of Oryzon
“The Phase IIb trial in schizophrenia, EVOLUTION, continues to enroll patients across several European countries, and we expect to complete enrollment in spring 2027, with topline data anticipated by the end of 2027.”
Dr. Carlos Buesa, Chief Executive Officer of Oryzon
“This readout could represent an important inflection point for the company’s CNS program.”
Dr. Carlos Buesa, Chief Executive Officer of Oryzon
“The recent authorization of the HOPE-2 Phase II study in Phelan-McDermid syndrome marks another step forward for the program.”
Dr. Carlos Buesa, Chief Executive Officer of Oryzon
“In parallel, we are progressing with preparations for thePORTICO-2 Phase III trial in BPD and plan to request a Type C meeting with the FDA.”
Dr. Carlos Buesa, Chief Executive Officer of Oryzon
“Across our portfolio, we remain focused on disciplined execution, responsible allocation of resources and the continued strengthening of our intellectual property as we prepare for the next stages of clinical development.”
* Updated clinical data from three iadademstat studies to be presented at ASH 2026, including encouraging results from ALICE-2 in first-line AML (95% ORR, 84% CRc and 74% CR) and FRIDA in relapsed/refractory FLT3-mutated AML (67% CRc rate at the recommended Phase II dose) * New VIVALDI study evaluating iadademstat in first-line AML authorized in Spain, complementing preparations for the planned ALICE-3 Phase III program * Vafidemstat EVOLUTION Phase IIb trial in schizophrenia continues enrolling patients across several European countries * Vafidemstat Phase III PORTICO-2 trial in aggression in borderline personality disorder (BPD): Preparatory activities progress, with a planned FDA Type C meeting * Vafidemstat Phase II HOPE-2 trial in Phelan-McDermid syndrome (PMS) receives authorization to initiate in Spain * Cash position as of September 30, 2026, was $21.7 million (€19.1 million) MADRID and CAMBRIDGE, Mass., Nov. 10, 2026 (GLOBE NEWSWIRE) -- Oryzon Genomics, S.A. (ISIN Code: ES0167733015, ORY), a clinical-stage biopharmaceutical company and a global leader in epigenetics, today reported financial results for the three months ended September 30, 2026, and provided a corporate update on recent developments.
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