37.8% of voting rights present or representedAll resolutions were approved MADRID and CAMBRIDGE, Mass., Dec. 15, 2025 (GLOBE NEWSWIRE) -- Oryzon Genomics S.A. (ISIN Code: ES0167733015, ORY), a clinical-stage biopharmaceutical company and global leader in epigenetics, today announced the results of voting at the Extraordinary General Shareholders' Meeting held last Friday in Madrid. A total of 33,581,589 of the Company's issued and outstanding voting rights (representing 37.7938% of the share capital) were a ...

100% Overall response rate (ORR) in triple combo study with azacitidine and venetoclax in newly diagnosed AML patients80% CR and 90% Composite Complete Remissions (CCR); median OS not reached after 9 months and good tolerability70% of patients derived to Hematopoietic Stem Cell Transplantation (HSCT) 67% CCR at the expansion dose in study evaluating iadademstat plus gilterinib in FLT3-mutated relapsed/refractory AML patients; 47% CR+CRhTreatment was safe and well tolerated MADRID, SPAIN and CAMBRIDGE, Mass. ...

Core Insights - Oryzon Genomics reported a significant financial turnaround, securing over $60 million in the first half of 2025, enabling a renewed focus on CNS clinical programs, particularly in Borderline Personality Disorder (BPD), schizophrenia, and Autism Spectrum Disorder (ASD) [3][4][8] - The company is advancing its clinical pipeline with promising data from its oncology asset iadademstat, showing a 100% overall response rate in a Phase I trial for acute myeloid leukemia (AML) [7][11] - Oryzon is enhancing its clinical and regulatory teams by incorporating experienced professionals to strengthen its late-stage pipeline and improve interactions with regulatory bodies [6][8] Financial Performance - For the nine months ended September 30, 2025, research and development expenses were $9.6 million, up from $7.1 million in the same period of 2024, while general and administrative expenses increased to $3.9 million from $3.1 million [12][13] - The net loss for the quarter was $1.2 million, compared to a loss of $1.1 million in the same quarter of 2024, reflecting the typical financial profile of a biotechnology company in the development phase [13][14] - Cash, cash equivalents, and marketable securities totaled $40.4 million as of September 30, 2025, a significant increase from $8.4 million in the previous year [14][16] Clinical Developments - The company is preparing to resubmit the revised Phase III protocol for vafidemstat in BPD following FDA feedback, which included guidance on study endpoints and non-clinical considerations [4][5] - Oryzon is expanding its clinical trials for vafidemstat in schizophrenia to additional EU countries and is preparing a new Phase II trial for aggression in ASD [5][8] - The iadademstat combination therapy has shown promising results in ongoing trials for various hematologic malignancies, with additional studies planned for sickle cell disease and essential thrombocythemia [11][22] Strategic Partnerships and Collaborations - Oryzon is exploring potential partnerships for its oncology asset iadademstat to enhance its value and ensure the drug reaches patients [3][8] - The company is collaborating with the National Cancer Institute (NCI) under a Cooperative Research and Development Agreement (CRADA) to further develop iadademstat in different cancer types [11][21] Patent Portfolio - Oryzon has strengthened its patent portfolio for both vafidemstat and iadademstat, with new patents granted or allowed in multiple jurisdictions, ensuring protection for their innovative therapies until at least 2038 and 2040, respectively [8][11][22]

Core Insights - Oryzon Genomics announced that three abstracts featuring iadademstat, a selective LSD1 inhibitor, have been accepted for presentation at the 67th American Society of Hematology Annual Meeting, highlighting its potential in treating acute myeloid leukemia (AML) and myeloproliferative neoplasms (MPNs) [1][2][4] Company Developments - The accepted abstracts showcase promising clinical activity and safety data from ongoing studies of iadademstat in combination with gilteritinib and venetoclax-azacitidine for AML patients [2][3] - Dr. Ana Limón emphasized that the addition of iadademstat enhances efficacy without increasing toxicity, particularly in the FLT3+ relapsed/refractory population, where 42% of patients had previously been treated with venetoclax [3][4] - Dr. Carlos Buesa expressed satisfaction with the selection of iadademstat abstracts for ASH 2025, underscoring its potential as a versatile epigenetic modulator in AML [4] Clinical Study Highlights - The FRIDA study (NCT05546580) is evaluating the safety and tolerability of iadademstat combined with gilteritinib in FLT3-mutated relapsed/refractory AML, with 34 patients enrolled and a 67% response rate reported [5][6] - A Phase Ib trial combining iadademstat with azacitidine and venetoclax in newly diagnosed, unfit AML patients showed a 100% overall response rate and 88% complete remission [7][8] - A Trial-in-progress abstract details a new randomized study of iadademstat in combination with ASTX727 for advanced MPNs, addressing the critical need for new treatments in this area [8][10] Future Directions - Oryzon is expanding the clinical development of iadademstat into non-oncological hematology indications, including trials for sickle cell disease and essential thrombocythemia [13] - The company is also exploring the use of iadademstat in solid tumors, indicating a broadening of its therapeutic applications [13]

Core Insights - Oryzon Genomics, a clinical-stage biopharmaceutical company, is a leader in epigenetics and focuses on personalized medicine for CNS disorders and oncology [3]. Upcoming Events - Oryzon management will participate in BIO-EUROPE from November 3-5 in Vienna, Austria, and the LSX Investival Showcase Europe 2025 on November 17 in London, UK [1][2]. - One-on-one meetings will be available during these conferences [2]. Company Overview - Founded in 2000 in Barcelona, Spain, Oryzon specializes in epigenetics and has a clinical portfolio that includes two LSD1 inhibitors: vafidemstat (Phase III-ready for CNS) and iadademstat (Phase II for oncology) [3]. - The company is also developing ORY-4001, targeting HDAC-6 for potential applications in CMT and ALS [3]. - Oryzon has a robust platform for biomarker identification and target validation across various malignant and neurological diseases [3].

Core Insights - Oryzon Genomics has announced a strategic collaboration with Dr. Iman Barilero as Senior Advisor for Regulatory Affairs to advance its Phase III clinical program for vafidemstat in Borderline Personality Disorder (BPD) [1][4] Company Overview - Oryzon Genomics is a clinical-stage biopharmaceutical company founded in 2000 in Barcelona, Spain, and is a leader in epigenetics, focusing on personalized medicine for CNS disorders and oncology [5] - The company has a clinical portfolio that includes two LSD1 inhibitors: vafidemstat (Phase III-ready) and iadademstat (Phase II) [5] Regulatory Expertise - Dr. Iman Barilero brings over 30 years of global regulatory leadership experience, particularly in CNS, neuropsychiatry, and rare diseases, with a successful track record in guiding Phase II-III programs and securing global approvals [2][3] - Her previous role as Vice President at Lundbeck involved leading global regulatory strategies for breakthrough therapies targeting various CNS disorders [3] Clinical Development - Vafidemstat is currently being evaluated in a double-blind, randomized, placebo-controlled Phase IIb trial (EVOLUTION) for its potential to improve negative symptoms in schizophrenia [4][8] - The company is also preparing a clinical trial for vafidemstat in Autism Spectrum Disorder (ASD) and has conducted several Phase IIa trials with positive results in psychiatric disorders [8] Strategic Goals - The collaboration with Dr. Barilero aims to enhance regulatory dialogue with the FDA and provide strategic guidance across clinical development programs [7] - Oryzon's pipeline includes programs targeting schizophrenia and ASD, with a focus on advancing its late-stage pipeline in BPD and schizophrenia [4][8]

Core Insights - Oryzon Genomics has received a Decision to Grant from the European Patent Office for its patent application EP20712594.9, which covers the use of iadademstat in combination with PD1 or PD-L1 inhibitors for cancer therapy, including small cell lung cancer (SCLC) [1][2] 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 a clinical portfolio that includes two LSD1 inhibitors: vafidemstat (Phase III-ready) and iadademstat (Phase II) [5] - Oryzon's team consists of experienced professionals from the pharmaceutical industry, with locations in Barcelona, Boston, and San Diego [5] Product Development - Iadademstat is a selective inhibitor of the epigenetic enzyme LSD1, currently being investigated in various clinical trials for hematologic cancers and solid tumors [6] - The drug is being tested in combination with PD-L1 inhibitors in a Phase I/II trial for extensive-disease SCLC patients, sponsored by the U.S. National Cancer Institute [4][6] - Iadademstat has shown promising safety and efficacy in trials for acute myeloid leukemia (AML) and is being evaluated for other indications, including sickle cell disease and essential thrombocythemia [6] Patent and Market Position - The granted patent for iadademstat will remain in force until at least 2040, with corresponding patents already allowed in Australia and Russia, and applications pending in the U.S., Japan, and China [2][3] - The patent strengthens Oryzon's position in the market for cancer therapies that utilize immune checkpoint inhibitors [3]

Core Insights - Oryzon Genomics, a clinical-stage biopharmaceutical company, is a European leader in epigenetics, focusing on personalized medicine for CNS disorders and oncology [3] Company Events - Oryzon management will participate in several upcoming events, including the Drug Discovery Innovation Programme on September 25-26 in Barcelona, and the Paris Midcap Event from September 30 to October 1 [1][2] - Additional events include the BME Investor Access Event on October 7 in Paris, BIOSPAIN 2025 from October 7-9 in Barcelona, and the 25th Sachs Annual Biotech in Europe Forum on October 8-9 in Basel, where Oryzon will present on October 8 at 13:45 CET [2] Company Overview - Founded in 2000 in Barcelona, Oryzon has a strong clinical portfolio featuring two LSD1 inhibitors: vafidemstat, which is Phase III-ready for CNS, and iadademstat, currently in Phase II for oncology [3] - The company is also developing ORY-4001, a clinical candidate targeting HDAC-6 for potential applications in CMT and ALS, alongside a robust platform for biomarker identification and target validation for various diseases [3]

Core Insights - Oryzon Genomics is expanding its patent portfolio for its clinical-stage LSD1 inhibitors, iadademstat and vafidemstat, with recent patent grants from the Australian and European patent offices [1][4]. Patent Developments - The Australian Patent Office granted a patent for iadademstat, covering its use in combination with PD1 or PD-L1 inhibitors for cancer treatment, including small cell lung cancer (SCLC), valid until at least 2040 [2]. - A corresponding patent for iadademstat has also been granted in Russia, with pending applications in Europe, the U.S., Japan, China, and other countries [2]. - The European Patent Office granted a patent for vafidemstat, which covers its use in treating aggressiveness and social withdrawal associated with CNS diseases, valid until at least 2038 [4]. - Additional patents for vafidemstat have been granted in various countries, with pending applications in others [4]. Clinical Trials and Research - Iadademstat is being evaluated in a Phase I/II trial in combination with PD-L1 inhibitors for extensive disease SCLC, sponsored by the U.S. National Cancer Institute [3]. - Vafidemstat is in advanced clinical development for treating aggression in psychiatric disorders, with a Phase III trial for Borderline Personality Disorder (BPD) and ongoing Phase II trials for Autism Spectrum Disorder (ASD) and schizophrenia [5][10]. - Iadademstat has shown promising results in various trials, including a Phase IIa trial in combination with azacitidine for acute myeloid leukemia (AML) [9]. Company Overview - Oryzon Genomics, founded in 2000, is a clinical-stage biopharmaceutical company based in Barcelona, Spain, focusing on epigenetics and personalized medicine in CNS disorders and oncology [7]. - The company has a robust clinical portfolio, including two LSD1 inhibitors, with ongoing research into other epigenetic targets [7].

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]