MADRID and CAMBRIDGE, Mass., Sept. 25, 2025 (GLOBE NEWSWIRE) -- Oryzon Genomics, S.A. (ISIN Code: ES0167733015, ORY), a clinical-stage biopharmaceutical company and a European leader in epigenetics, announced today that its management will participate at the following upcoming events: Drug Discovery Innovation Programme, September 25-26Location: Intercontinental Hotel, Barcelona, Spain Paris Midcap Event 2025, September 30-October 1Location: Four Seasons George V, Paris, France BME Investor Access Event 202 ...

Study led by CureShankAims to characterize the direct and indirect burden of PMS to patients, caregivers, and US healthcare system MADRID and CAMBRIDGE, Mass., Sept. 22, 2025 (GLOBE NEWSWIRE) -- Oryzon Genomics, S.A. (ISIN Code: ES0167733015, ORY), a clinical-stage biopharmaceutical company and a European leader in epigenetics, is proud to announce its participation as a sponsor of the first-ever Phelan-McDermid syndrome (PMS) burden of illness study. The study is led by CureShank, a research advocacy organ ...

MADRID and CAMBRIDGE, Mass., Sept. 16, 2025 (GLOBE NEWSWIRE) -- Oryzon Genomics, S.A. (ISIN Code: ES0167733015, ORY), a clinical-stage biopharmaceutical company and a European leader in epigenetics, today announced that it continues to expand its patent portfolio for iadademstat and vafidemstat, Oryzon’s clinical-stage LSD1 inhibitors for oncology and central nervous system (CNS) disorders, following new Decisions to Grant from the Australian and European patent offices. The Australian Patent Office has iss ...

Core Points - Oryzon Genomics has been selected as a Finalist in the 2025 European Lifestars Awards for the category Post-IPO Raise of the Year in the European Mediterranean region [1][2] - The nomination is attributed to the successful completion of a €30 million capital increase, which involved issuing 12.76 million new shares at €2.35 per share, reflecting a 15.44% discount to the 5-day volume-weighted average price and a 19.38% discount to the April 22, 2025 closing price [3] - The capital raise was significantly oversubscribed, with a U.S.-based institutional investor contributing €15 million, and additional participation from investors across the U.S., Europe, and Spain [3] Company Overview - Oryzon Genomics, founded in 2000 in Barcelona, Spain, is a clinical-stage biopharmaceutical company specializing in epigenetics and personalized medicine, particularly in CNS disorders and oncology [5] - The company has an advanced clinical portfolio that includes two LSD1 inhibitors, vafidemstat (Phase III-ready) and iadademstat (Phase II), along with other pipeline assets targeting various epigenetic mechanisms [5] - Oryzon has established a strong platform for biomarker identification and target validation for a range of malignant and neurological diseases [5]

MADRID and CAMBRIDGE, Mass., July 30, 2025 (GLOBE NEWSWIRE) -- Oryzon Genomics, S.A. (ISIN Code: ES0167733015, ORY), a clinical-stage biopharmaceutical company and a European leader in epigenetics, today reported financial results for the half-year ended June 30, 2025 and provided a corporate update on recent developments. Since last December, the company has secured $61 million in funding, including $35.2 million (€30 million) from a successful capital raise completed in April through a straight equity iss ...

Core Insights - Oryzon Genomics is hosting a virtual KOL event to discuss the unmet medical needs in Borderline Personality Disorder (BPD) and the design of vafidemstat's Phase III PORTICO-2 trial [1] - The event will address the lack of approved pharmacological treatments for BPD and the limitations of off-label medications, emphasizing the importance of addressing agitation and aggression in BPD and other psychiatric conditions [1] - Vafidemstat is highlighted as a promising treatment option due to its novel epigenetic mechanism of action, with ongoing discussions about its potential applications in BPD, schizophrenia, and autism spectrum disorder (ASD) [1] Company Overview - Oryzon Genomics, founded in 2000 in Barcelona, Spain, is a clinical-stage biopharmaceutical company specializing in epigenetics and personalized medicine for CNS disorders and oncology [9] - The company has a clinical portfolio that includes two LSD1 inhibitors: vafidemstat (Phase III-ready) and iadademstat (Phase II) [9] - Oryzon is also focused on biomarker identification and target validation for various malignant and neurological diseases [9] Vafidemstat Details - Vafidemstat (ORY-2001) is an oral, CNS-optimized LSD1 inhibitor that has shown efficacy in reducing cognitive impairment and neuroinflammation, as well as having neuroprotective effects [10] - The drug has demonstrated positive results in multiple Phase IIa clinical trials, including studies on aggression in psychiatric disorders and Alzheimer's disease [10] - Vafidemstat is advancing towards a Phase III trial in BPD following the completion of the Phase IIb PORTICO trial, with plans to investigate its effects on agitation and aggression [10]

MADRID and CAMBRIDGE, Mass., June 23, 2025 (GLOBE NEWSWIRE) -- Oryzon Genomics, S.A. (ISIN Code: ES0167733015, ORY), a clinical-stage biopharmaceutical company and a European leader in epigenetics, announced today that it has submitted the clinical trial protocol for its Phase III PORTICO-2 trial to the U.S. Food and Drug Administration (FDA) to initiate a registrational trial to evaluate vafidemstat in patients with Borderline Personality Disorder (BPD). The PORTICO-2 trial builds upon the encouraging resu ...

Core Insights - Oryzon Genomics is participating in the 2025 Phelan-McDermid Syndrome Congress, highlighting its commitment to addressing rare genetic disorders through its research and development efforts [1][2] Company Participation and Events - Oryzon is sponsoring the CureSHANK's 2nd Annual Phelan-McDermid Syndrome Drug Development Symposium and the III Scientific Conference of the Spanish Phelan-McDermid Syndrome Association, which will take place from June 26 to June 29, 2025 [2] - Dr. Jordi Xaus, Oryzon's Chief Scientific Officer, will engage in a panel discussion on industry perspectives related to clinical trials and business considerations [1][7] Research and Development Focus - Oryzon is exploring the potential of vafidemstat, an LSD1 inhibitor, for treating rare monogenic psychiatric disorders, including Phelan-McDermid Syndrome (PMS) and Autism Spectrum Disorder (ASD) [3][5] - In the Phase IIb PORTICO trial for Borderline Personality Disorder (BPD), vafidemstat showed nominal statistical significance in reducing agitation and aggression, which are also key symptoms in PMS [3][7] Collaborations and Publications - Oryzon has collaborated with the Medical and Molecular Genetics Institute and the Research Institute La Paz Hospital to publish findings on the clinical characterization of PMS, which will support future clinical trials with vafidemstat [4] - The company has received €13.5 million from the EU IPCEI Med4Cure project to validate epigenetic drugs like vafidemstat through a personalized medicine approach for rare diseases [5] Product Pipeline and Clinical Trials - Vafidemstat is currently the only LSD1 inhibitor in clinical development for central nervous system (CNS) disorders, with ongoing trials in various psychiatric conditions, including BPD and schizophrenia [6][8] - The drug has demonstrated efficacy in reducing cognitive impairment and neuroinflammation in preclinical models, and it is advancing towards Phase III trials following positive results from earlier studies [8]

Core Insights - Oryzon Genomics, a clinical-stage biopharmaceutical company, is focused on epigenetics and personalized medicine, particularly in CNS disorders and oncology [3][4][5] Company Overview - Founded in 2000 in Barcelona, Spain, Oryzon is recognized as a European leader in epigenetics with a strong clinical portfolio [3] - The company has two LSD1 inhibitors: vafidemstat (Phase III-ready for CNS) and iadademstat (Phase II for oncology) [3] - Oryzon is also developing ORY-4001, targeting HDAC-6 for conditions like CMT and ALS, and has a robust platform for biomarker identification [3] Clinical Development - Iadademstat (ORY-1001) is a selective LSD1 inhibitor showing promising results in hematologic cancers, with ongoing trials in combination therapies for AML [4] - Vafidemstat (ORY-2001) is a CNS-optimized LSD1 inhibitor demonstrating efficacy in cognitive impairment and neuroinflammation, with positive results in various Phase IIa trials [5][6] Upcoming Events - Oryzon will participate in several international events, including Foro Medcap 2025 in Madrid, BIO International Convention 2025 in Boston, and Discovery and Development Europe 2025 in Basel, where they will engage with investors and present their research [2]

Financial Highlights - Oryzon Genomics reported a successful completion of a €30 million capital increase, oversubscribed from an initial €25 million target, with strong international demand [2][14] - The company secured a non-refundable EU grant of €13.26 million through the Med4Cure project, representing 64% of the total accepted budget for the project [15] - Research and development expenses for Q1 2025 were $2.6 million, consistent with the previous year, while general and administrative expenses increased to $1.2 million from $0.9 million [11][12] Clinical Development Updates - The company is finalizing preparations for the Phase III PORTICO-2 trial of vafidemstat for treating agitation and aggression in Borderline Personality Disorder (BPD), with a planned submission to the FDA in the first half of 2025 [2][8] - Oryzon continues patient recruitment for the ongoing EVOLUTION trial in schizophrenia, focusing on vafidemstat's efficacy in improving negative symptoms [4][24] - The Phase I/II trial of iadademstat in combination with immune checkpoint inhibitors for small cell lung cancer (SCLC) has begun patient recruitment, with the trial sponsored by the National Cancer Institute (NCI) [4][7] Research and Development Focus - Oryzon is exploring precision medicine trials for conditions like Fragile X syndrome and Phelan-McDermid syndrome, with potential IND submissions planned for 2025 [6][24] - The company is actively enrolling patients in the FRIDA trial, evaluating iadademstat in combination with gilteritinib for relapsed/refractory acute myeloid leukemia (AML) [16] - Oryzon's patent portfolio for vafidemstat has been strengthened with new patents related to treating ADHD and autism spectrum disorders, with protections extending until at least 2040 [8][24] Market Position and Strategy - Oryzon is positioned as a European leader in epigenetics, focusing on personalized medicine in CNS disorders and oncology [21] - The company has a robust clinical portfolio with two LSD1 inhibitors, vafidemstat and iadademstat, targeting significant unmet medical needs in various psychiatric and oncological conditions [21][22] - Oryzon's strategy includes leveraging collaborations with leading institutions and expanding clinical trials to enhance its market presence and therapeutic offerings [9][22]