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ORYZON to Attend the 2025 Phelan-McDermid Syndrome (PMS) Congress in Barcelona on June 26-29
Globenewswire· 2025-06-17 12:00
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]
Global Longevity Summit 2025: Spotlight on Dr. Steve Horvath, New Advisory Board Members, and Early Registration Opportunity
Globenewswire· 2025-06-12 15:00
Core Insights - The Global Longevity Summit is set to take place from October 28–30, 2025, at the Genolier Innovation Hub in Geneva, Switzerland, focusing on advancements in aging science and human performance [3][5] - Dr. Steve Horvath, a biogerontologist and epigenetic researcher, will be the keynote speaker and will receive the 2025 Global Longevity Award for his work on the epigenetic clock [2][3] - The event will feature 300 global leaders from healthcare, science, business, and capital, emphasizing the theme "Mastering the Aging Clock: The Science of Longevity" [3][4] Event Details - The Summit will include discussions on epigenetics, regenerative medicine, AI-powered health optimization, and precision intervention strategies [3] - New members have been appointed to the Scientific and Professional Advisory Board, enhancing the event's multidisciplinary approach [4] - Early registration is encouraged due to rising demand, with ticket prices set to increase on July 1 [5] Participation Information - The Global Longevity Summit is an invitation-only event, requiring participant approval for qualified professionals and executives in the longevity ecosystem [6][7] - Interested participants can apply for access through the official website [6]
Volition Announces Two Oral Presentations at Asian Meeting of Animal Medicine Specialties
Prnewswire· 2025-06-05 01:00
Core Insights - VolitionRx Limited is presenting its Nu.Q® Vet Cancer Test at the Asian Meeting of Animal Medicine Specialties (AMAMS 2025) in Thailand, highlighting its potential as a diagnostic tool for veterinary oncology [1][2] - The test has shown promise in differentiating between benign and malignant conditions, particularly Canine Chronic Enteropathy and Gastrointestinal Lymphoma, according to Dr. Masahiko Sato [2] - The company aims to enhance awareness and adoption of the Nu.Q® Vet Cancer Test through clinical research and presentations by leading veterinarians [2] Company Overview - Volition is a multi-national epigenetics company focused on advancing the science of epigenetics to improve outcomes for people and animals with life-altering diseases through earlier detection and monitoring [3] - The company is developing cost-effective blood tests for various diseases, including cancers and conditions associated with NETosis, with the goal of prolonging life and improving quality of life for patients [4] - Volition's research and development activities are primarily based in Belgium, with additional facilities in the U.S. and London [5]
ORYZON to Provide Corporate Progress Updates at Several Events in May-June
Globenewswire· 2025-05-27 12:00
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]
VolitionRx Limited Announces Successful Detection of Nucleosomes in Cats
Prnewswire· 2025-05-19 12:30
Clinical Paper Published in BMC Veterinary Research HENDERSON, Nev., May 19, 2025 /PRNewswire/ -- VolitionRx Limited (NYSE AMERICAN: VNRX) ("Volition"), a multi-national epigenetics company, today announces the publication of "Evaluation of plasma nucleosome concentrations and the effect of pre-analytical variables in healthy cats" in BMC Veterinary Research. This is the first study to report the detection of nucleosomes in cats: previously nucleosome levels have been shown to increase in dogs and humans in ...
VolitionRx Limited Announces First Quarter 2025 Financial Results and Business Update
Prnewswire· 2025-05-15 21:37
Core Insights - VolitionRx Limited is focusing on commercializing its Nu.Q® platform in the human diagnostics market, with ongoing discussions with over ten companies, whose combined market value exceeds $600 billion [2] - The company aims to secure multiple licensing agreements in the human diagnostics space this year, similar to its strategy in the veterinary market [3] - Volition recorded its first revenue from sales of its CE-marked Nu.Q® NETs automated product in Europe in Q1 2025, marking a significant commercial milestone [4] Financial Highlights - Volition reported approximately $0.25 million in revenue for Q1 2025, a 44% increase compared to the same quarter in the previous year [8] - The net cash used in operating activities averaged $1.4 million per month, nearly 50% lower than in Q1 2024 [8] - The company received $4.3 million in funding during Q1 2025, with about $1.8 million from non-dilutive funding [8] - As of March 31, 2025, cash and cash equivalents totaled approximately $2.6 million, down from $3.3 million as of December 31, 2024 [8] - A convertible loan note was finalized post-quarter end, providing $6.25 million in gross proceeds, repayable over 24 months [8] - The goal for 2025 is to achieve cash neutrality, where income matches expenditure on a cash basis [8]
VolitionRx Limited Schedules First Quarter 2025 Earnings Conference Call and Business Update
Prnewswire· 2025-05-12 12:30
Volition is a multi-national company focused on advancing the science of epigenetics. Volition is dedicated to saving lives and improving outcomes for people and animals with life-altering diseases through earlier detection, disease and treatment monitoring. Through its subsidiaries, Volition is developing and commercializing simple, easy to use, cost-effective blood tests to help detect and monitor a range of diseases, including some cancers and diseases associated with NETosis, such as sepsis. Early detec ...
ORYZON Reports Financial Results and Corporate Update for Quarter Ended March 31, 2025
Globenewswire· 2025-05-12 12:00
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]
Illumina Q1 Earnings Top Estimates, Revenues Down Y/Y, Stock Dips
ZACKS· 2025-05-09 13:50
Core Insights - Illumina Inc. reported first-quarter 2025 adjusted earnings per share (EPS) of 97 cents, exceeding the Zacks Consensus Estimate by 1%, but down 1% year-over-year [1] - The company's GAAP EPS was 82 cents, reflecting an 86.4% increase year-over-year [1] Revenue Performance - Revenues for the first quarter amounted to $1.04 billion, a decrease of 1.4% year-over-year, but slightly above the Zacks Consensus Estimate by 0.2% [2] - The stock fell 2.2% in after-market trading following the earnings announcement [2] Segment Analysis - Core Illumina's sequencing service and other revenues totaled $142 million, down 5% year-over-year, primarily due to timing of strategic partnership revenues [3] - Sequencing consumable revenues reached $696 million, up 1% year-over-year, driven by high-throughput consumables [3] Margin and Expense Overview - Adjusted gross margin was 67.2%, an increase of 79 basis points year-over-year, attributed to a 5.5% decline in the cost of revenues [4] - Research and development expenses decreased by 25.7% year-over-year to $252 million, while SG&A expenses totaled $267 million, down 39.2% from the previous year [4] - Adjusted operating profit for the quarter was $181 million, compared to an operating loss of $63 million in the same quarter last year [4] Financial Position - At the end of Q1 2025, Illumina had cash and cash equivalents of $1.11 billion, slightly down from $1.13 billion at the end of Q4 2024 [5] - Cumulative net cash provided by operating activities was $240 million, compared to $77 million a year ago [5] 2025 Guidance - For 2025, Illumina expects Core Illumina revenues to decline by 1%-3% on a constant currency basis, revised from earlier low single-digit growth expectations [6] - The Zacks Consensus Estimate for 2025 revenues is currently $4.31 billion [6] - Non-GAAP diluted EPS is projected to be in the range of $4.20-$4.30, down from the previous estimate of $4.50-$4.65 [7] Key Developments - Illumina made significant announcements in Q1, including innovations in genomics, spatial transcriptomics, and collaborations with Broad Clinical Labs and the Broad Institute [8][9] - The company sequenced 250,000 whole genomes for the Alliance for Genomic Discovery initiative [9] Overall Assessment - Illumina's earnings and revenues beat estimates, with positive progress in the NovaSeq X transition among clinical customers [10] - Despite the positive aspects, both top and bottom lines showed year-over-year declines, reflecting the impact of evolving policy and geopolitical developments [11]
ORYZON Awarded €13.26 Million Through the First Important Project of Common European Interest (IPCEI) in the Health Sector (Med4Cure Project)
Globenewswire· 2025-05-08 12:00
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]