Oryzon Genomics has appointed Rolando Gutierrez-Esteinou, as chief medical officer for its CNS programs. Based in New Jersey USA, he will lead clinical development for Oryzon’s neuroscience pipeline, including its lead program, vafidemstat.

Carlos Buesa, chief executive officer of Oryzon, said: “Rolando is an outstanding addition to Oryzon’s executive team. 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.”

Dr Gutierrez-Esteinou previously served as chief medical officer at Atai Life Sciences, where he oversaw multiple clinical-stage CNS programs and built multidisciplinary development teams. His career spans senior roles at global pharmaceutical companies, including Johnson & Johnson, Bristol Myers Squibb, and Novartis, as well as biotech and CRO environments. He has led clinical development from Phase I through Phase IV across major neuropsychiatric disorders including schizophrenia, mood disorders, addiction, and cognitive impairment, and has contributed to late-stage development programs and regulatory submissions such as sNDAs and label expansions for established CNS therapies.

Dr Gutierrez-Esteinou said: “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. 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 also expressed gratitude to Dr Michael Ropacki, who has led the vafidemstat program as CMO–CNS over the past six years.