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ORYZON Receives Feedback From the FDA in Response to the Submitted Phase III Protocol in Borderline Personality Disorder
Globenewswire· 2025-10-17 16:08
Core Insights - Oryzon Genomics has received feedback from the FDA regarding its Phase III protocol for vafidemstat in borderline personality disorder (BPD), which will be revised and resubmitted [2][3] - The company views the FDA's feedback as an opportunity to enhance the trial design and improve the chances of bringing a first-in-class therapy to patients with BPD [3] Company Overview - Oryzon Genomics, founded in 2000 in Barcelona, Spain, is a clinical-stage biopharmaceutical company specializing in epigenetics, 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 is also developing other pipeline assets targeting various epigenetic mechanisms, including ORY-4001 for CMT and ALS [5] Product Details - Vafidemstat (ORY-2001) is an oral, CNS-optimized LSD1 inhibitor that has shown potential in reducing cognitive impairment and neuroinflammation [6] - Preclinical studies indicate vafidemstat can restore memory and reduce aggressive behavior in models of Alzheimer's disease [6] - The drug has demonstrated efficacy in several Phase IIa trials for various psychiatric disorders and is currently being evaluated in a Phase IIb trial for schizophrenia [6][4]
VolitionRx Limited Announces Pricing of $6.0 Million Underwritten Public Offering of Common Stock and Common Stock Warrants
Prnewswire· 2025-10-10 12:30
Core Viewpoint - VolitionRx Limited has announced a public offering of 11,550,000 shares of common stock and warrants, aiming to raise approximately $6.0 million in gross proceeds before expenses [1][3]. Offering Details - The public offering price is set at $0.52 per share, with each warrant priced at $0.01, and an exercise price of $0.60 per share [1]. - The underwriter has a 30-day option to purchase an additional 1,732,500 shares and warrants to cover overallotments [2]. - If the warrants are fully exercised, the additional gross proceeds could reach approximately $6.9 million [3]. Use of Proceeds - The net proceeds from the offering will be utilized for research, product development, clinical studies, commercialization, working capital, and potential strategic acquisitions [4]. Company Overview - Volition is a multinational company focused on advancing epigenetics, aiming to improve early detection and monitoring of diseases [8]. - The company is developing cost-effective blood tests for various diseases, including certain cancers and conditions associated with NETosis [9]. - Research and development activities are primarily based in Belgium, with additional offices in the U.S. and London [10].
VolitionRx Limited Announces Proposed Underwritten Public Offering of Common Stock and Common Stock Warrants
Prnewswire· 2025-10-09 20:05
Core Viewpoint - VolitionRx Limited is proposing an underwritten public offering of its common stock and accompanying purchase warrants, with a potential additional 15% option for the underwriter [1][2]. Group 1: Offering Details - The offering will be made under a "shelf" registration statement previously filed with the SEC, and the final terms will depend on market conditions [3]. - Newbridge Securities Corporation is acting as the sole book-running manager for the offering [2]. Group 2: Use of Proceeds - The net proceeds from the offering are intended for research, product development, clinical studies, commercialization, working capital, and potential strategic acquisitions [2]. Group 3: Company Overview - Volition is a multinational company focused on advancing epigenetics to improve early detection and monitoring of diseases, including cancers and conditions associated with NETosis [5][6]. - The company's research and development activities are primarily based in Belgium, with additional offices in the U.S. and London [7].
Volition Sponsors Upcoming GenomeWeb Webinar
Prnewswire· 2025-10-02 12:45
Core Insights - VolitionRx Limited is sponsoring a GenomeWeb webinar focused on epigenetic modifications for biomarker and drug discovery, scheduled for October 8, 2025 [1][2]. Company Overview - VolitionRx is a multi-national epigenetics company dedicated to advancing the science of epigenetics, aiming to improve outcomes for patients with life-altering diseases through early detection and monitoring [7][8]. - The company is developing cost-effective blood tests for diagnosing and monitoring various diseases, including certain cancers and conditions associated with NETosis, such as sepsis [8]. Webinar Details - The webinar will feature Dr. Eric Ariazi discussing major epigenetic pathways and their implications in health and disease, particularly focusing on cancer immunoediting and pharmacologic inhibitors [3]. - Dr. Marielle Herzog will present case studies on Volition's Nu.Q assays, which are designed to support disease research and clinical development [4]. Nu.Q® Discover Program - The Nu.Q® Discover program offers drug developers and scientists access to advanced assays for rapid epigenetic profiling, facilitating research from discovery to market readiness [5][6]. - This program utilizes proprietary nucleosome quantification technology, serving as a valuable tool for R&D professionals in pharmaco-epigenetics [6].
ORYZON Strengthens Patent Portfolio for iadademstat with European Grant Decision Covering Combinations with PD1/PD-L1 Inhibitors
Globenewswire· 2025-10-01 12:00
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]
ORYZON to Participate in Upcoming Events in September and October
Globenewswire· 2025-09-25 12:00
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]
ORYZON to Sponsor First Phelan-McDermid Syndrome (PMS) Burden of Illness Study
Globenewswire· 2025-09-22 12:00
Core Insights - Oryzon Genomics is sponsoring the first Phelan-McDermid syndrome (PMS) burden of illness study, led by CureShank, to assess the economic impact of PMS and guide therapy development [1][2][3] Company Overview - Oryzon Genomics, founded in 2000 in Barcelona, Spain, is a clinical-stage biopharmaceutical company specializing in epigenetics, particularly in CNS disorders and oncology [6] - The company has a clinical portfolio that includes two LSD1 inhibitors: vafidemstat (Phase III-ready) and iadademstat (Phase II) [6] Study Details - The PMS study aims to collect data from families, health insurance claims, and clinical experts to quantify the economic burden of PMS and inform future market access strategies [2][8] - The study will help identify key drivers of the burden, which can guide new interventions and accelerate treatment development [3] Disease Context - PMS is a neurodevelopmental disorder caused by mutations in the SHANK3 gene, leading to developmental delays, intellectual disabilities, and behavioral issues [4] - There are currently no approved pharmacological treatments for PMS, highlighting the need for effective therapies [4] Clinical Trials - Oryzon is preparing a Phase II trial named HOPE-2 to evaluate the safety and efficacy of vafidemstat in PMS, expected to start soon [5] - Vafidemstat has shown promise in preclinical models for reversing social-behavior and aggression phenotypes associated with ASD [5][7]
ORYZON Strengthens Patent Portfolio for Iadademstat and Vafidemstat with New Decisions to Grant
Globenewswire· 2025-09-16 12:00
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].
Unpacking and breaking the cycle of intergenerational trauma | Zuzanna Wabnik | TEDxIILOPoznań
TEDx Talks· 2025-09-04 15:26
Have you ever caught yourself acting in a way that eerily mirrors your parents behavior. Maybe you shut down during conflict, avoid vulnerability, or feel guilty for taking a break. Not because you chose to, but because that's what you grew up seeing.Maybe your father went silent when things got tense, and your mother buried her needs for the sake of stability, and now somehow you're doing the same. It's easy to dismiss these reactions as personality quirks, but what if there's something deeper. What if the ...
ORYZON Finalist at the 2025 European Lifestars Awards
Globenewswire· 2025-09-04 12:00
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]