MADRID and CAMBRIDGE, Mass., Feb. 19, 2026 (GLOBE NEWSWIRE) -- Oryzon Genomics, S.A. (ISIN Code: ES0167733015, ORY), a clinical-stage biopharmaceutical company and global leader in epigenetics, announced today that its management will participate at the following upcoming events: Bio-Neuroscience 2026, February 24-27Location: Hotel Jakarta, Amsterdam SmallCap Event 20th Edition, March 17Location: Les Salons Hoche, Paris BIO-Europe Spring 2026, March 23-25Location: Feira Internacional de Lisboa (FIL), Lisbon ...

Core Insights - Oryzon Genomics has appointed Dr. Rolando Gutierrez-Esteinou as Chief Medical Officer for CNS Programs, bringing over 20 years of experience in neuroscience and psychiatry drug development [1][2][3] - Dr. Gutierrez-Esteinou will lead the Phase III clinical development of vafidemstat, targeting agitation and aggression in borderline personality disorder, while also expanding its use in autism spectrum disorder and schizophrenia [2][4] - Oryzon is recognized as a leader in epigenetics, focusing on personalized medicine for CNS disorders and oncology, with a clinical portfolio that includes two LSD1 inhibitors [5][6] Company Overview - Oryzon Genomics, founded in 2000 and headquartered in Barcelona, Spain, is a clinical-stage biopharmaceutical company specializing in epigenetics [5] - The company has a strong clinical portfolio, including vafidemstat, which is Phase III-ready, and iadademstat, which is in ongoing Phase I and II studies with promising results in acute myeloid leukemia [5][6] - Oryzon is advancing a broader epigenetics pipeline, including a clinical candidate for Charcot-Marie-Tooth disease and amyotrophic lateral sclerosis [6]

Core Insights - Oryzon Genomics has initiated a Phase Ib trial for iadademstat, a selective LSD1 inhibitor, in combination with radiotherapy and an immune checkpoint inhibitor for extensive stage small cell lung cancer (ES-SCLC) patients [1][2][3] Group 1: Trial Details - The trial, titled "Iadademstat and Radiation Therapy With Atezolizumab in Extensive Stage Small-cell Lung Cancer (ES-SCLC) Patients With Persistent, Recurrent or Progressive Disease After First Line Systemic Therapy," is an open-label, non-randomized study [2] - It will evaluate the safety, tolerability, and efficacy of iadademstat combined with atezolizumab and stereotactic body radiation therapy (SBRT) [2] - The study will enroll patients who have previously received platinum-based chemotherapy with or without immune checkpoint inhibitor therapy [2] Group 2: Company Overview - Oryzon Genomics, founded in 2000 in Barcelona, Spain, is a clinical-stage biopharmaceutical company focused on epigenetics and personalized medicine in CNS disorders and oncology [4] - The company has a clinical portfolio that includes two LSD1 inhibitors: vafidemstat (Phase III-ready) and iadademstat (Phase II) [4] - Oryzon is also developing other pipeline assets targeting different epigenetic mechanisms, including HDAC-6 [4] Group 3: Iadademstat Profile - Iadademstat (ORY-1001) is a small oral molecule that selectively inhibits the epigenetic enzyme LSD1, showing promising results in hematologic cancers [5] - Previous trials have demonstrated its safety and preliminary antileukemic activity, with encouraging results in combination with azacitidine [5] - The drug is currently being evaluated in various studies, including combinations with azacitidine and venetoclax in first-line acute myeloid leukemia (AML) [5][7] Group 4: Research and Development Focus - The combination of LSD1 inhibition with immunotherapy and radiotherapy is seen as a compelling strategy for treating aggressive cancers like SCLC [3] - Oryzon is expanding iadademstat's clinical development into non-oncological hematology indications, with trials in sickle cell disease and essential thrombocythemia [7] - Iadademstat has received orphan drug designation for SCLC and AML in both the US and EU [7]

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] Group 1: Upcoming Events - Oryzon management will participate in the 9th Sachs Annual Neuroscience Innovation Forum on January 11, 2026, in San Francisco, with a presentation scheduled at 10:35 am (PST) [1] - The company will also attend the 44th Annual J.P. Morgan Healthcare Conference from January 12-15, 2026, in San Francisco, and the Allinvest Securities Biomed Forum on January 29, 2026, in Paris, where one-on-one meetings will be available [2] Group 2: Company Overview - Founded in 2000 in Barcelona, Oryzon is recognized as the European leader in epigenetics, with a clinical portfolio that includes two LSD1 inhibitors: vafidemstat (Phase III-ready) for CNS and iadademstat (Phase II) for oncology/hematology [3] - The company is developing other pipeline assets targeting epigenetic mechanisms, including ORY-4001 for potential use in CMT and ALS, and has a robust platform for biomarker identification and target validation across various malignant and neurological diseases [3]

Core Insights - Oryzon Genomics has received a patent grant from the Japanese Patent Office for its application related to combinations of iadademstat for cancer therapy, which is a significant step in enhancing its patent portfolio [1][2][3] Patent Protection - The granted patent is expected to remain effective until at least 2040, excluding any potential extensions, securing Oryzon's intellectual property in Europe, Japan, Australia, and Russia [2] - Oryzon is actively pursuing corresponding patent applications in other countries to further strengthen its global patent coverage [2] Clinical Development - Iadademstat is being evaluated in combination with immune checkpoint inhibitors, specifically atezolizumab and durvalumab, for the treatment of small cell lung cancer (SCLC) in an ongoing Phase I/II trial sponsored by the U.S. National Cancer Institute [3] - The trial is being conducted at over 30 clinical sites across the U.S., including prestigious institutions like Memorial Sloan Kettering Cancer Center and Johns Hopkins [3] Company Overview - Founded in 2000, Oryzon Genomics is a clinical-stage biopharmaceutical company based in Barcelona, Spain, focusing on epigenetics and personalized medicine in oncology and CNS disorders [4] - The company has a robust clinical portfolio, including two LSD1 inhibitors: vafidemstat (Phase III-ready) and iadademstat (Phase II) [4] Iadademstat Details - Iadademstat (ORY-1001) is a selective inhibitor of the epigenetic enzyme LSD1, showing promising results in hematologic cancers and is currently in various clinical trials for conditions such as acute myeloid leukemia (AML) and small cell lung cancer [5][6] - The drug has demonstrated safety and preliminary efficacy in multiple trials, including a Phase IIa trial in combination with azacitidine for elderly AML patients [5]

Core Insights - Oryzon Genomics S.A. held an Extraordinary General Shareholders' Meeting where 33,581,589 voting rights were represented, accounting for 37.7938% of the share capital [1][6]. Resolutions Approved - All resolutions proposed by the Board of Directors received favorable votes ranging from 93% to 98% [2]. - Key resolutions included amendments to the Company's Bylaws, approval of a new Remuneration Policy for directors, and a Long-Term Incentive Plan for executives [7]. Financial and Corporate Actions - A capital increase of up to €125 million was approved, with the exclusion of preemptive subscription rights [7]. - The Company is focused on personalized medicine in CNS disorders and oncology/hematology, with a clinical portfolio that includes two LSD1 inhibitors [4].

Core Insights - Oryzon Genomics reported promising clinical data for iadademstat, a selective LSD1 inhibitor, in treating acute myeloid leukemia (AML) at the 67th ASH Annual Meeting, indicating potential for significant clinical benefits in combination with standard therapies [1][4] Group 1: Clinical Study Results - The ALICE-2 study showed a 100% overall response rate (ORR) and a 90% composite complete remission (CCR) rate in newly diagnosed AML patients treated with iadademstat, azacitidine, and venetoclax [2][5] - In the FRIDA study, 67% CCR and 47% combined CR and CRh were observed in patients with FLT3-mutant relapsed/refractory AML, demonstrating the efficacy of iadademstat combined with gilteritinib [3][5] Group 2: Safety and Tolerability - Both clinical studies reported that iadademstat was safe and well tolerated, with adverse event profiles comparable to other combination treatments in AML [2][3] - The ongoing dose-finding studies are focused on determining the maximum tolerated dose (MTD) for iadademstat in these patient populations [2][3] Group 3: Future Development and Strategic Partnerships - The CEO of Oryzon emphasized the potential of iadademstat as a best-in-class combination agent, indicating plans for future clinical development and exploration of strategic partnerships to maximize its value [4][6] - Oryzon is also expanding iadademstat's clinical applications beyond hematological cancers, with ongoing trials in sickle cell disease and essential thrombocythemia [7]

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].