What did the FDA’s feedback to Oryzon Genomics, S.A. cover?

The FDA’s feedback covered elements including the selection of study endpoints and certain non-clinical considerations for the proposed Phase III protocol.

What is Oryzon Genomics, S.A. planning to do with its Phase III protocol for vafidemstat?

Oryzon Genomics, S.A. plans to revise and resubmit the Phase III protocol for vafidemstat in BPD, incorporating the FDA’s feedback.

What has Oryzon Genomics, S.A. said about its discussions with the FDA?

Oryzon Genomics, S.A. said that iterative interactions are common in regulatory dialogue and that it looks forward to continued engagement with the FDA as it finalises the next steps.

What did Oryzon Genomics, S.A. management say about the revised Phase III programme?

Chief Executive Officer Carlos Buesa said the company viewed the FDA’s feedback as an opportunity to optimise the Phase III programme and that aligning the study with the Agency’s recommendations would strengthen the trial design. He described vafidemstat as a potential first-in-class therapy, rather than a confirmed treatment, and said the company was actively revising the protocol with support from international clinical advisors and regulatory specialists.

What is Oryzon Genomics, S.A. studying vafidemstat for?

Oryzon Genomics, S.A. is developing vafidemstat for evaluation in borderline personality disorder and is also assessing it in schizophrenia.

What other clinical trial is Oryzon Genomics, S.A. running for vafidemstat?

Oryzon Genomics, S.A. is evaluating vafidemstat in a double-blind, randomized, placebo-controlled Phase IIb trial assessing its potential to improve negative symptoms in schizophrenia. The trial is named EVOLUTION.

What did Oryzon Genomics, S.A. say about its other CNS clinical programmes?

Oryzon Genomics, S.A. said that its other ongoing clinical programmes in central nervous system (CNS) indications continue as planned.

What does Oryzon Genomics, S.A. do and where do its shares trade?

Oryzon Genomics, S.A. describes itself as a clinical-stage biopharmaceutical company focused on epigenetics. Its shares are identified in the announcement by ISIN Code: ES0167733015 and BME: ORY.

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Oryzon receives FDA feedback on Phase III vafidemstat protocol for BPD

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Oryzon Genomics S.A.

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Oryzon receives FDA feedback on Phase III vafidemstat protocol for BPD

Q: When will Oryzon Genomics, S.A. provide its next update on the vafidemstat protocol?

Oryzon Genomics, S.A. expects to provide a further update once the revised protocol has been submitted and subsequent discussions with the FDA are underway.

Published Friday, 17 October 2025

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At a glance

Company: Oryzon Genomics S.A.
Listings: BME:ORY, OTC PINK:ORYZF
Announcement type: Regulatory approval
Published: Friday, 17 October 2025
Source announcement: oryzon.com

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

Announcement Summary

Oryzon Genomics, S.A. (ISIN Code: ES0167733015, BME: ORY) said on October 17, 2025, that it received written feedback from the U.S. Food and Drug Administration (FDA) on its Phase III protocol for vafidemstat in borderline personality disorder (BPD). The feedback covers study endpoint selection and certain non-clinical considerations.

Oryzon will incorporate the feedback and resubmit the revised protocol. The company expects to provide a further update once the revised protocol has been submitted and subsequent discussions with the FDA are underway. Its other ongoing clinical programs in CNS continue as planned, and vafidemstat is being evaluated in the double-blind, randomized, placebo-controlled Phase IIb EVOLUTION trial in schizophrenia.

Investor FAQs

Oryzon Genomics, S.A. announced that it had received written feedback from the U.S. Food and Drug Administration (FDA) on its Phase III protocol for evaluating vafidemstat in borderline personality disorder (BPD). The company said it will incorporate the feedback and resubmit the revised protocol.

Source announcement

Company: Oryzon Genomics S.A.
Title: ORYZON receives feedback from the FDA in response to the submitted Phase III protocol in Borderline Personality Disorder
Published: Friday, 17 October 2025
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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