ORYZON Strengthens Vafidemstat Patent Portfolio With U.S. Notice of Allowance
MWN-AI** Summary
Oryzon Genomics, S.A. has announced a significant advancement in its patent portfolio for vafidemstat, an LSD1 inhibitor in clinical development for psychiatric disorders, particularly borderline personality disorder (BPD). The United States Patent and Trademark Office (USPTO) has issued a Notice of Allowance for patent application US 17/439,575, entitled "Methods of treating borderline personality disorder." This new patent is particularly crucial as it covers the use of LSD1 inhibitors for addressing non-aggressive symptoms of BPD and solidifies Oryzon's position in a field with considerable unmet medical needs. The U.S. patent, once granted, will last until at least 2040, potentially bolstering commercial prospects for vafidemstat.
In addition to this recent allowance in the U.S., Oryzon has secured corresponding patents in other jurisdictions, including Australia, Europe, Japan, and more, enhancing its global intellectual property strategy. Oryzon's Chief IP Officer, Neus Virgili, emphasized that this Notice of Allowance supports the drug's long-term development and underscores its commercial potential.
Vafidemstat is known for its multiple therapeutic capabilities, targeting symptoms like cognitive impairment and neuroinflammation while showcasing efficacy in various preclinical studies. Oryzon has undertaken several Phase II trials, yielding promising results in behavioral symptoms across psychiatric disorders, including aggression and agitation in patients with moderate to severe Alzheimer's disease.
The company continues to work on expanding the clinical potential of vafidemstat in various central nervous system disorders, with ongoing trials investigating its efficacy in schizophrenia and other specific conditions. Oryzon remains committed to harnessing epigenetic approaches to develop targeted therapies in the dynamically evolving biopharmaceutical landscape.
MWN-AI** Analysis
Oryzon Genomics has made a significant stride in its ongoing mission to carve a niche in the treatment of psychiatric disorders with the recent Notice of Allowance from the U.S. Patent and Trademark Office for vafidemstat. This patent application, particularly for treating non-aggressive symptoms of Borderline Personality Disorder (BPD), fortifies Oryzon's intellectual property portfolio, thereby enhancing the competitive landscape advantage that can be capitalized on in the coming years.
Investors should recognize that this patent could extend vafidemstat's exclusivity in the U.S. until at least 2040, providing Oryzon with a substantial period to maximize potential revenue while minimizing competition. The flourishing patent landscape in multiple jurisdictions (including Europe and Japan) further underscores the robustness of Oryzon’s strategy in establishing a foothold in the market for innovative psychiatric treatments.
The potential market for addressing BPD is sizable, with many patients experiencing debilitating symptoms that are inadequately treated by current offerings. Vafidemstat’s demonstrated efficacy in reducing cognition impairment and its anti-inflammatory capabilities position it favorably as a candidate capable of fulfilling this unmet medical need.
From an investment perspective, Oryzon presents a compelling case amidst its clinical advancements, particularly in LSD1 inhibitors. The company’s pipeline, including vafidemstat and iadademstat, is currently poised for significant next steps, notably entering Phase III clinical trials. Given the rigorous data from previous trials, which highlighted strong efficacy and safety profiles, prospective investors might find this an opportune time to evaluate the company's shares.
Long-term investors should thus consider Oryzon Genomics favorably due to its expanding intellectual property, strong clinical foundation, and the high demand in the psychiatric treatment landscape. However, as always, cautious optimism is advised, as the biotech sector can be volatile and contingent upon successful clinical trial outcomes.
**MWN-AI Summary and Analysis is based on asking OpenAI to summarize and analyze this news release.
- Covers the use of vafidemstat for treating non-aggressive symptoms of Borderline Personality Disorder (BPD)
MADRID, and CAMBRIDGE, Mass., March 25, 2026 (GLOBE NEWSWIRE) -- Oryzon Genomics, S.A. (ISIN Code: ES0167733015, ORY), a clinical-stage biopharmaceutical company and global leader in epigenetics, today announced that the United States Patent and Trademark Office (USPTO) has issued a Notice of Allowance for its patent application US 17/439,575, entitled “Methods of treating borderline personality disorder”, further strengthening its intellectual property portfolio for vafidemstat, Oryzon’s LSD1 inhibitor in clinical development for the treatment of psychiatric disorders, including borderline personality disorder (BPD). The allowed claims cover the use of LSD1 inhibitors for the treatment of non-aggressive symptoms of BPD, complementing Oryzon’s patent portfolio in aggression.
Once granted, the U.S. patent is expected to remain in force until at least 2040, excluding any potential patent term adjustments or extensions. Corresponding patents have been granted or allowed in Australia, Europe, Japan, Mexico, Russia, Singapore, and South Africa, with additional applications pending in other jurisdictions.
“This U.S. Notice of Allowance reinforces our intellectual property position for vafidemstat in borderline personality disorder and supports its long-term development and commercial potential in an area of significant unmet medical need,” said Neus Virgili, Oryzon’s Chief IP Officer.
In addition to this patent family, Oryzon holds other patents covering the use of vafidemstat for the treatment of CNS disorders, including a patent family directed to the treatment of aggression and social withdrawal, with patents granted or allowed in Australia, Canada, Europe, Hong Kong, Israel, Japan, South Korea, Malaysia, the Philippines, and Russia, and additional applications pending in other jurisdictions. These patents are expected to remain in force until at least 2038, excluding any potential patent term extensions.
About Oryzon
Founded in 2000 and headquartered in Barcelona, Spain, Oryzon (ISIN: ES0167733015) is a clinical-stage biopharmaceutical company and a European leader in epigenetics, with a strong focus on personalized medicine for central nervous system (CNS) disorders and oncology. Oryzon’s team comprises highly experienced pharmaceutical professionals based in Barcelona, Boston, and New Jersey. The Company has an advanced clinical portfolio built around two LSD1 inhibitors: iadademstat, its oncology/hematology program, with several ongoing Phase I and II studies and outstanding preliminary results in first-line acute myeloid leukemia, including a 100% overall response rate (ORR) presented at ASH 2025; and vafidemstat, its lead CNS program, which is Phase III–ready. In addition, Oryzon is advancing a broader epigenetics pipeline targeting other mechanisms, including HDAC6, for which a clinical candidate, ORY-4001, has been nominated for potential development in Charcot–Marie–Tooth disease (CMT) and amyotrophic lateral sclerosis (ALS). The Company also operates a robust platform for biomarker identification and target validation across a range of malignant and neurological diseases. For more information, visit www.oryzon.com
About Vafidemstat
Vafidemstat (ORY-2001) is an oral, CNS-optimized LSD1 inhibitor. The molecule acts on several levels: it reduces cognitive impairment, including memory loss and neuroinflammation, and at the same time has neuroprotective effects. In animal studies vafidemstat not only restores memory but reduces the exacerbated aggressiveness of SAMP8 mice, a model for accelerated aging and Alzheimer’s disease (AD), to normal levels and also reduces social avoidance and enhances sociability in murine models. In addition, vafidemstat exhibits fast, strong, and durable efficacy in several preclinical models of multiple sclerosis (MS). Oryzon has performed two Phase IIa clinical trials in aggressiveness in patients with different psychiatric disorders (REIMAGINE, see Ferrer et al, Psychiatry & Clin Neurosci, 2025, doi.org/10.1111/pcn.13800) and in aggressive/agitated patients with moderate or severe AD (REIMAGINE-AD), with positive clinical results reported in both. Additional finalized Phase IIa clinical trials with vafidemstat include the ETHERAL trial in patients with Mild to Moderate AD, where a significant reduction of the inflammatory biomarker YKL40 was observed after 6 and 12 months of treatment, and the pilot, small-scale SATEEN trial in Relapse-Remitting and Secondary Progressive MS, where anti-inflammatory activity was also observed. Vafidemstat has also been tested in a Phase II in severe Covid-19 patients (ESCAPE) assessing the capability of the drug to prevent ARDS, one of the most severe complications of the viral infection, where it showed significant anti-inflammatory effects in severe Covid-19 patients. Following completion of the global, randomized, double blind Phase IIb PORTICO trial in Borderline Personality Disorder (BPD), with final data presented at ECNP-2024, vafidemstat is advancing as a Phase III-ready asset for agitation/aggression in BPD (PhIII in preparation). Vafidemstat is also being investigated in a double-blind, randomized, placebo-controlled Phase IIb trial in negative symptoms of schizophrenia (EVOLUTION trial, recruitment ongoing). The company is also deploying a CNS precision medicine approach with vafidemstat in genetically defined patient subpopulations of certain CNS disorders, as well as in neurodevelopmental syndromes, and is preparing a clinical trial in aggression in autistic conditions like Phelan-McDermid syndrome.
FORWARD-LOOKING STATEMENTS
This communication contains, or may contain, forward-looking information and statements about Oryzon, including financial projections and estimates and their underlying assumptions, statements regarding plans, objectives, and expectations with respect to future operations, capital expenditures, synergies, products and services, and statements regarding future performance. Forward-looking statements are statements that are not historical facts and are generally identified by the words “expects,” “anticipates,” “believes,” “intends,” “estimates” and similar expressions. Although Oryzon believes that the expectations reflected in such forward-looking statements are reasonable, investors and holders of Oryzon shares are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Oryzon that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include those discussed or identified in the documents sent by Oryzon to the Spanish Comisión Nacional del Mercado de Valores (CNMV), which are accessible to the public. Forward-looking statements are not guarantees of future performance and have not been reviewed by the auditors of Oryzon. You are cautioned not to place undue reliance on the forward-looking statements, which speak only as of the date they were made. All subsequent oral or written forward-looking statements attributable to Oryzon or any of its members, directors, officers, employees, or any persons acting on its behalf are expressly qualified in their entirety by the cautionary statement above. All forward-looking statements included herein are based on information available to Oryzon on the date hereof. Except as required by applicable law, Oryzon does not undertake any obligation to publicly update or revise any forward?looking statements, whether as a result of new information, future events, or otherwise. This document does not constitute an offer or invitation to purchase or subscribe shares in accordance with the provisions of Regulation (EU) 2017/1129 of the European Parliament and of the Council of 14 June 2017, and/or the restated text of the Securities Market Law, approved by Law 6/2023 of 17 March, and its implementing regulations. Nothing in this document constitutes investment advice. In addition, this document does not constitute an offer of purchase, sale or exchange, nor a request for an offer of purchase, sale or exchange of securities, nor a request for any vote or approval in any jurisdiction. The shares of Oryzon Genomics, S.A. may not be offered or sold in the United States of America except pursuant to an effective registration statement under the Securities Act of 1933 or pursuant to a valid exemption from registration..
| Spain | Oryzon | IR & Media, Europe & US | |
| Patricia Cobo/Mario Cordera | Emili Torrell | Sandya von der Weid | |
| Atrevia | Chief BD Officer | LifeSci Advisors, LLC | |
| +34 91 564 07 25 +34 673 33 97 65 | +34 93 515 1313 | +41 78 680 05 38 | |
| pcobo@atrevia.com mcordera@atrevia.com | etorrell@oryzon.com | svonderweid@lifesciadvisors.com |
FAQ**
How does Oryzon Genomics S.A. (ORYZF) plan to leverage the recently allowed patent for vafidemstat in treating non-aggressive symptoms of BPD to enhance its market position in this area?
What specific non-aggressive symptoms of Borderline Personality Disorder is vafidemstat targeting, and how does Oryzon Genomics S.A. (ORYZF) differentiate its approach from existing treatments?
Can Oryzon Genomics S.A. (ORYZF) provide insights into the clinical trial timeline and expected outcomes for vafidemstat's Phase III readiness in treating agitation/aggression in BPD?
What strategies is Oryzon Genomics S.A. (ORYZF) implementing to address the significant unmet medical need for effective treatments of non-aggressive symptoms in BPD as they develop vafidemstat?
**MWN-AI FAQ is based on asking OpenAI questions about Oryzon Genomics S.A. (OTC: ORYZF).
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