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VolitionRx Highlights Commercial Momentum and Multi-Pillar Execution
Prnewswire· 2026-02-25 13:10
Core Insights - VolitionRx Limited has made significant clinical and commercial progress, highlighting licensing momentum and advancements in various diagnostic technologies [1][2] Group 1: Licensing and Commercialization - The company is in active discussions with approximately 10 global diagnostic leaders for licensing agreements [1][2] - Anticipated announcements of additional agreements during 2026 as negotiations progress [2] Group 2: Clinical Developments - The Nu.Q® NETs assay is included in a $7.3 million government-backed DETECSEPS program in France for early sepsis detection [1] - A reimbursement submission for lung cancer testing in France is underway, with routine clinical use expected by Q4 2026 [1] - New clinical utility of the Nu.Q® NETs assay has been demonstrated for managing Hidradenitis Suppurativa, a disease affecting about 1% of the global population [1] Group 3: Market Opportunities - The Capture-Seq™ platform presents a $23 billion annualized opportunity in cancer detection [1][2] - The total addressable market for Nu.Q® NETs in sepsis and chronic conditions is estimated at $3.8 billion [2] - The Nu.Q® Vet (Canine/Feline) market is projected to exceed $1 billion, with the canine test already commercially available [2] Group 4: Veterinary Breakthroughs - The Nu.Q® Vet Feline assay achieved 100% specificity in detecting feline lymphoma, marking a significant advancement in veterinary diagnostics [1] - This breakthrough is expected to unlock a $5 million milestone payment upon publication in a peer-reviewed journal [1]
ORYZON to Participate in Upcoming Events in February and March
Globenewswire· 2026-02-19 13:00
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 ...
Resverlogix Closes $2.8 Million Shares-for-Interest Private Placement
TMX Newsfile· 2026-02-19 00:00
Calgary, Alberta--(Newsfile Corp. - February 18, 2026) - Resverlogix Corp. (TSX: RVX) ("Resverlogix") announced today that it has closed a $2.8 million shares-for-interest private placement with an immediate family member (the "Subscriber") of Resverlogix's Chairman and CEO. Under the terms of the shares-for-interest transaction, the Subscriber subscribed for 28,000,000 common shares at CAD$0.10 per share for aggregate proceeds of CAD$2.8 million. After giving effect to the transaction, the Subscriber hold ...
ORYZON Announces Appointment of Rolando Gutierrez-Esteinou, M.D., as Chief Medical Officer for CNS
Globenewswire· 2026-02-12 13:00
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]
Volition Announces the Appointment of New Distributor for Nu.Q® Discover
Prnewswire· 2026-02-10 13:07
Core Insights - VolitionRx Limited has appointed Medical & Biological Laboratories Co. Ltd (MBL) as a non-exclusive distributor for its Nu.Q® Discover assays in Japan, enhancing its market presence in the region [1] - The company serves nearly 100 clients globally, including major pharmaceutical and diagnostic firms, and anticipates continued revenue growth for Nu.Q® Discover in 2026 [1] - The Total Accessible Market for relevant companion diagnostics is estimated to be just under $1 billion, indicating significant growth potential [1] Company Developments - The collaboration with MBL is expected to generate interest and data for potential future regulatory applications for diagnostic status in Japan [1] - In 2025, Volition achieved several milestones, including a co-marketing agreement with Hologic Diagenode and the first commercial sale of its High Throughput Synthetic Sepsis method [1] - The Nu.Q® Discover program provides advanced assays for rapid epigenetic profiling, supporting drug developers and researchers in various therapeutic areas [1] Market Context - MBL, established in 1969, is a leading provider of clinical research tools in Japan, focusing on autoimmune diseases and genetic diagnostics [1] - The partnership aims to expand access to nucleosome-based biomarkers for drug developers and researchers, contributing to advancements in personalized medicine [1] - VolitionRx is dedicated to improving disease detection and monitoring through cost-effective blood tests, with a focus on cancers and diseases related to NETosis [1]
ORYZON Announces First Patient Dosed in an Investigator-Initiated Phase Ib Study of Iadademstat in Extensive Stage Small Cell Lung Cancer
Globenewswire· 2026-02-09 13:00
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]
Volition Sponsors Symposium at 15th Conference of the European Hidradenitis Suppurativa Foundation
Prnewswire· 2026-02-04 13:45
Core Viewpoint - VolitionRx Limited is sponsoring a symposium at the European Hidradenitis Suppurativa Foundation Conference to present findings on the Nu.Q NETs assay, which aids in the management of Hidradenitis Suppurativa (HS) through a precision medicine approach [1][2][3]. Company Overview - VolitionRx Limited is a multi-national epigenetics company focused on advancing the science of epigenetics and improving outcomes for patients through earlier detection and monitoring of diseases [11][12]. - The company is developing cost-effective blood tests for various diseases, including cancers and conditions associated with NETosis, aiming to enhance patient quality of life [12]. Industry Context - Hidradenitis Suppurativa (HS) is a chronic condition affecting approximately 1% of the global population, characterized by painful skin abscesses and scarring [3][9]. - The condition is difficult to manage, and the introduction of biological treatments has shown varied responses among patients, highlighting the need for a precision medicine approach [4][9]. Product and Market Potential - The Nu.Q NETs assay is CE-Marked for clinical use in 27 EU member states and is positioned as a simple, low-cost test to detect diseases associated with NETosis, with a total addressable market estimated at $3.8 billion [6][8]. - The assay aims to classify HS patients and guide treatment decisions, potentially improving patient management and outcomes [4][6].
ORYZON Strengthens Patent Portfolio for Vafidemstat With New Decision to Grant in Japan
Globenewswire· 2026-02-02 13:00
Core Viewpoint - Oryzon Genomics has received a "Decision to grant" communication from the Japanese Patent Office for its patent application related to vafidemstat, an LSD1 inhibitor in clinical development for treating psychiatric disorders, specifically targeting aggression and social withdrawal [1][2][3] Patent and Intellectual Property - The allowed claims cover the use of vafidemstat for treating aggression and social withdrawal, symptoms associated with various CNS disorders [2] - The Japanese patent will remain in force until at least 2038, with potential extensions, and corresponding patents have been granted in multiple countries including Europe, Australia, and Canada [3][4] - Oryzon holds additional patents for vafidemstat targeting CNS disorders, expected to remain valid until at least 2040, enhancing the company's intellectual property position [5] Clinical Development - Oryzon is preparing a Phase III trial for vafidemstat to evaluate its efficacy in treating aggression in borderline personality disorder (BPD) and has ongoing Phase II trials in autism spectrum disorder (ASD) and schizophrenia [2][8] - Vafidemstat has shown positive results in previous Phase IIa trials for aggression in psychiatric disorders and has demonstrated anti-inflammatory effects in severe Covid-19 patients [7][8] Company Overview - Founded in 2000, Oryzon Genomics is a clinical-stage biopharmaceutical company focused on epigenetics and personalized medicine in CNS disorders and oncology, with a strong clinical portfolio including two LSD1 inhibitors [6] - The company is advancing a precision medicine approach in CNS disorders, preparing trials for genetically defined patient subpopulations [8]
VolitionRx Limited Announces the Preparation of Reimbursement Submission for its Nu.Q® Cancer Assays
Prnewswire· 2026-01-30 13:50
Core Insights - VolitionRx Limited is preparing a reimbursement submission for its Nu.Q® Cancer assays in France, supported by the Hospices Civils de Lyon, aiming for clinical certification of the test [1][2][3] Group 1: Company Developments - The reimbursement submission is expected to be completed by the end of the current quarter under the "Innovative Procedures Outside the Nomenclature" framework, with a determination of eligibility for reimbursement coverage anticipated within five months [2][3] - VolitionRx aims to introduce the Nu.Q® test into routine clinical use in France by the fourth quarter of 2026, marking a significant milestone in the commercialization of its cancer diagnostics [3] Group 2: Clinical and Market Impact - There are approximately 50,000 new lung cancer diagnoses annually in France, with a five-year prevalence of around 65,000 cases, indicating a substantial market opportunity for the Nu.Q® Cancer assays [3] - The Nu.Q® test is expected to enhance precision in treatment selection and monitoring for lung cancer patients, providing valuable information regarding survival and progression-free survival [2][3] Group 3: Collaborations and Support - The collaboration with Hospices Civils de Lyon is crucial for the submission process, as they are France's second-largest university hospital system, which will facilitate the integration of the Nu.Q® test into clinical practice [2][5] - The support from HCL underscores the strong scientific and clinical evidence developed over several years to validate the use of Nu.Q® in cancer management [2]
Volition Continues to Extend Access to Nu.Q® Vet Cancer Test
Prnewswire· 2026-01-20 13:25
Core Insights - VolitionRx Limited has appointed two new centralized laboratory providers for its Nu.Q® Vet Cancer test, enhancing access to its canine cancer early detection tool in the U.S. and Asia [1][7] Company Overview - Volition is a multi-national epigenetics company focused on advancing the science of epigenetics to improve outcomes for people and animals through earlier detection of diseases [3][4] - The company is dedicated to developing cost-effective blood tests for various diseases, including cancers and conditions associated with NETosis, such as sepsis [4] Market Opportunity - The Total Addressable Market (TAM) for the Nu.Q® Vet Cancer test is approximately $100 million across the U.S., Europe, and Japan, which could increase to nearly $150 million with the inclusion of China [3][7] Product Development - The Nu.Q® Canine Cancer Test can be integrated into annual checkups or senior wellness exams, allowing veterinarians to detect cancer earlier and assist pet owners in making informed decisions regarding cancer care [2][4]