Oryzon Genomics has captured the attention of investors after the announcement of favorable results from clinical studies targeting various mental health conditions. Following the release of these results, the stock of the biopharmaceutical company surged roughly 20% on one recent Monday, reaching €3.55, continuing the positive momentum it had observed the previous week.
Since the beginning of the year, the stock has doubled its value, pushing the company's market capitalization to over €200 million. Early last week, Oryzon disclosed the final results of the Phase IIa REIMAGINE study, which assessed the safety and efficacy of Vafidemstat for addressing aggression among adult patients with borderline personality disorder, attention deficit hyperactivity disorder, and autism spectrum disorder. This milestone was documented in the esteemed journal Psychiatry and Clinical Neurosciences.
According to Oryzon, the publication of these results aligns with its sustained commitment to advancing current knowledge surrounding the relevance of epigenetics within psychiatry and neurodevelopmental disorders. "This innovative study, one of the first basket trials within the CNS, was the first to demonstrate the safe and novel action mechanism of LSD1 inhibitors to treat agitation/aggression associated with psychiatric conditions," the company stated.
CEO Carlos Buesa expressed excitement about the potential of Vafidemstat as a promising molecule for managing agitation and aggression across different CNS disorders, as demonstrated by this Phase IIa trial. "We are enthusiastic about designing a Phase III trial in borderline personality disorder (BPD), with guidance from prominent U.S. psychiatrists, to evaluate its impact on this highly disabling trait of the disease. Successfully mitigating agitation and aggression could significantly improve the daily lives of patients with BPD. If next Phase III trial yields positive results, Vafidemstat could be explored more broadly for controlling aggression across other CNS disorders," he noted.
Advancements such as these are pivotal for Oryzon. Last October, the company received formal notification of its End-of-Phase II meeting for Vafidemstat concerning BPD with the United States Food and Drug Administration (FDA). At the time, they indicated plans to initiate the preparation of a comprehensive protocol for the Phase III PORTICO-2 study, which they would later submit to the FDA for approval.
For 2024, Oryzon's shareholders approved the board's authority to conduct capital increases of up to €100 million, as part of its strategic move to transition onto the Nasdaq. This step is seen as key for the company’s future ambitions.
Changes have also been put forth within the company’s leadership. Oryzon commenced the new year with significant shifts at the top. Pierre Beaurang has been appointed as the new advisor of Strategy and Business Development. He previously served as CEO and board member of Nitrase Therapeutics, focusing on novel enzymes related to neurodegenerative disorders and cancer, and was previously the Business Director at Nurix Therapeutics.
Oryzon also communicated plans to propose the addition of four new members to its board: Pierre Beaurang, Konstantinos Alataris, Montse Vendrell, and Luis Sánchez Quintana. Conversely, several current board members, including Ramón Adell, Isabel Aguilera, Antonio Fornieles, Josep María Echarri, and Tamara Maes, are stepping down from their respective roles.
With such dynamic changes and promising research outcomes, Oryzon Genomics appears well-positioned for significant growth and strategic advancements in the pharmaceutical industry, as it seeks to make strides toward Nasdaq listing and the progression of its innovative treatments.