ORYZON announces appointment of Rolando Gutierrez-Esteinou, M.D., as Chief Medical Officer for CNS

Oryzon Genomics, S.A. (ISIN Code: ES0167733015, ORY), a clinical-stage biopharmaceutical company and global leader in epigenetics, today announced the appointment of Rolando Gutierrez-Esteinou, M.D., as Chief Medical Officer, CNS Programs. Dr. Gutierrez-Esteinou is a Harvard-trained psychiatrist and an accomplished global clinical development executive with more than 20 years of leadership experience advancing neuroscience and psychiatry-focused drug development programs. He brings deep expertise in late-stage clinical execution, regulatory strategy, and pathways to market approval.

“Rolando is an outstanding addition to Oryzon’s executive team,” said Carlos Buesa, Chief Executive Officer of Oryzon. “He brings a rare combination of deep clinical expertise in psychiatry, extensive late-stage CNS development experience, and proven regulatory leadership. His strong track record in advancing innovative therapies through pivotal development and supporting successful regulatory submissions will be invaluable as we prepare to move vafidemstat, our lead CNS program, into Phase III clinical development for the treatment of agitation and aggression (A/A) in borderline personality disorder (BPD), while also expanding its clinical development in A/A in autism spectrum disorder and in negative symptoms of schizophrenia, with a clear path toward future regulatory approval.”

Most recently, Dr. Gutierrez-Esteinou served as Chief Medical Officer at Atai Life Sciences, where he oversaw a portfolio of clinical-stage CNS programs and built a multidisciplinary development organization supporting multiple trials across psychiatric indications. Throughout his career, he has held senior leadership roles across global pharmaceutical companies—including Johnson & Johnson, Bristol Myers Squibb, and Novartis—as well as in biotech and CRO environments. His experience spans clinical development from Phase I through Phase IV across major neuropsychiatric disorders, including schizophrenia, mood disorders, addiction, and cognitive impairment.

Dr. Gutierrez-Esteinou has contributed to multiple late-stage development programs and regulatory submissions, including supplemental New Drug Applications (sNDAs) and label expansions for established CNS therapies such as Risperdal® (risperidone) and Abilify® (aripiprazole). He has led regulatory interactions with major global health authorities, including the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), and Japan’s Pharmaceuticals and Medical Devices Agency (PMDA). He completed his psychiatry residency at Harvard Medical School and held research fellowships at Harvard/McLean Hospital and the U.S. National Institutes of Health (NIH).

“It is a privilege to join Oryzon as Chief Medical Officer and help advance vafidemstat, the only LSD1 inhibitor in clinical development for CNS indications, for the treatment of agitation and aggression in patients with borderline personality disorder”, said Dr. Gutierrez-Esteinou. “I came to Oryzon because they think differently about the pathophysiology of CNS disorders and the use of epigenetic approaches to seek safer, more effective treatments for people with BPD and other psychiatric disorders. People with BPD live with deep disability and distress that current medicines do not adequately relieve. Vafidemstat may become the first treatment of its kind in a field that has not seen progress in many years. My aim is to lead a clinical program that is scientifically rigorous, ethically sound, and truly centered on patients, so that it can bring real relief to those in need. We will work side by side with patients, investigators, and regulators, and we will move with the urgency that this serious unmet need demands.”

Oryzon would also like to recognize and express its sincere gratitude to Dr. Michael Ropacki, who has led the vafidemstat program as CMO–CNS over the past six years with exceptional professionalism and significant success.