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]

First iadademstat clinical trial in non-malignant hematological indications MADRID and CAMBRIDGE, Mass., Aug. 25, 2025 (GLOBE NEWSWIRE) -- Oryzon Genomics, S.A. (ISIN Code: ES0167733015, Ticker: ORY), a clinical-stage biopharmaceutical company and a European leader in epigenetics, today announced that the European Medicines Agency (EMA) has approved its Clinical Trial Application (CTA), the European equivalent to an IND, to initiate a Phase Ib trial of iadademstat in sickle cell disease (SCD). This will be ...

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 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]

Core Insights - Oryzon Genomics has received a non-refundable grant of approximately €13.26 million (around $15 million) for its VANDAM project, which is part of the Med4Cure initiative aimed at supporting pharmaceutical research and innovation in Europe [1][3][4] - The grant covers 64% of the total budget for the VANDAM project, which is €20.68 million [1][4] - The VANDAM project focuses on developing therapies for rare neurodevelopmental disorders and neuroendocrine tumors, with a personalized medicine approach [2][3] Company Overview - Oryzon Genomics is a clinical-stage biopharmaceutical company based in Barcelona, Spain, specializing in epigenetics and personalized medicine for CNS disorders and oncology [5] - The company has two main drug candidates: vafidemstat, which is in Phase III readiness for CNS disorders, and iadademstat, currently in Phase II for oncology [5][6] - Oryzon's team consists of experienced professionals from the pharmaceutical industry, with operations in Barcelona, Boston, and San Diego [5] Project Details - The VANDAM project, which stands for "Validation of epigenetic Agents for Neuro-related rare Diseases Applying a personalized Medicine approach," is a 44-month initiative that began in January 2023 and will conclude in August 2026 [2][3] - The project aims to improve the quality of life for patients with rare diseases by developing targeted therapies based on a deeper understanding of the molecular causes of these conditions [2][3] Strategic Importance - The grant is considered a key component of Oryzon's clinical strategy, enabling the acceleration of clinical development for vafidemstat and further exploration of its therapeutic potential in managing aggression in rare diseases, including specific subtypes of Autism Spectrum Disorder (ASD) [2][4] - The funding will also support the investigation of iadademstat in rare tumors and genetically driven hematological diseases, areas with significant unmet medical needs [2][4] Collaborative Framework - Med4Cure is a pan-European project involving 14 scientific initiatives developed by 13 companies across six EU Member States, coordinated in Spain by the Centro para el Desarrollo Tecnológico y la Innovación (CDTI) [3] - Oryzon participates as an Associated Partner within this consortium, which is integrated into Spain's national Recovery and Resilience Plan [3]

MADRID and CAMBRIDGE, Mass., April 24, 2025 (GLOBE NEWSWIRE) -- Oryzon Genomics, S.A. (ISIN Code: ES0167733015, ORY), a clinical-stage biopharmaceutical company and a European leader in epigenetics, announced today the successful completion of a €30 million capital increase through the issuance of 12,765,958 new shares, priced at €2.35 per share. This pricing reflects a 15.44% discount to the 5-day volume-weighted average price (VWAP) of €2.779 per share prior to April 22, 2025, and a 19.38% discount to the ...

New "Decision to grant" communications in Europe and Japan MADRID and CAMBRIDGE, Mass., April 21, 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 the European Patent Office has issued a "Decision to grant" communication for its European patent application EP20712563.4 relating to vafidemstat. The patent, titled "Methods of treating Attention Deficit Hyperactivity Disorder usin ...