ORYZON Secures Another Important Patent for its Lead CNS Asset, Vafidemstat Has received “Intention to Grant” from the European Patent Office For the treatment of aggression and social withdrawal MADRID, Spain and CAMBRIDGE, Mass., April 22, 2024 (GLOBE NEWSWIRE) -- Oryzon Genomics, S.A. (ISIN Code: ES0167733015, ORY), a clinical-stage biopharmaceutical company leveraging epigenetics to develop therapies in diseases with strong unmet medical need, announced today that the European Patent Office (EPO) has issued an “intention to grant” communication for Oryzon’s European patent applicatio...
With the FDA investigational new drug (IND) application clearance, Oryzon can commence its Phase I/II cooperative research and development agreement (CRADA) trial sponsored by the National Cancer Institute (NCI; part of the National Institutes of Health) with Dr Noura Choudhury from the Memorial Sloan Kettering Cancer Center (MSKCC) as the principal investigator. This trial will evaluate iadademstat in combination with immune checkpoint inhibitors (ICIs) for the treatment of first-line extensive...
ORYZON Announces U.S. FDA Clearance of CTEP-CRADA Phase I/II Clinical Trial Sponsored by NCI for Iadademstat Plus Immune Checkpoint Inhibitors in 1L Extensive Stage Small Cell Lung Cancer In combination with either atezolizumab or durvalumab MADRID, Spain and CAMBRIDGE, Mass., April 08, 2024 (GLOBE NEWSWIRE) -- Oryzon Genomics, S.A. (ISIN Code: ES0167733015, ORY), a clinical-stage biopharmaceutical company leveraging epigenetics to develop therapies in diseases with strong unmet medical need, announced today that the U.S. Food and Drug Administration (FDA) has approved the Investigation...
ORYZON to Provide Corporate Progress Updates at Several Events in April Investing in Oncology Forum 2024Van Lanschot Kempen Life Sciences Conference Swiss Biotech Day 2024LSX World Congress MADRID, Spain and BOSTON, April 05, 2024 (GLOBE NEWSWIRE) -- Oryzon Genomics, S.A. (ISIN Code: ES0167733015, ORY), a clinical-stage biopharmaceutical company leveraging epigenetics to develop therapies in diseases with strong unmet medical need, announced today that its management will give an update on corporate progress at several international events in April. Oryzon has been invited to attend the...
For the third consecutive time, Oryzon Genomics has received the INNOVATIVE SME Seal from the Spanish Ministry of Science and Innovation. This external recognition highlights Oryzon’s key R&D activities, including its lead central nervous system (CNS) asset, vafidemstat, and lead oncology asset, iadademstat, and overall contributions to the field of epigenetics. Along with the acknowledgement, the INNOVATIVE SME Seal may allow Oryzon to benefit from certain tax deductions and incentives, as well...
ORY FY23 results announcement covered an eventful period for the company’s pipeline, capped by the release of top-line data from the Phase IIb PORTICO trial for lead CNS asset vafidemstat. With the focus squarely on the planned end of Phase II (EoP2) meeting with the FDA and anticipated clinical updates on the remaining programmes, we see FY24 as a crucial period for the company, with multiple inflection points. Other key upcoming milestones include results from the FRIDA trial (iadademstat in F...
ORYZON Reports Financial Results and Corporate Update for Quarter Ended December 31, 2023 Topline data from vafidemstat's PORTICO Phase IIb trial in Borderline Personality Disorder (BPD) reported with promising results in secondary endpoints of overall severity and control of agitation/aggressionCompany planning to request an End-of-Phase II meeting with the FDA to discuss plans for a registrational Phase III trial in BPDContinues to enroll patients in Phase IIb EVOLUTION trial with vafidemstat in schizophreniaContinues to recruit patients in FRIDA trial with iadademstat in combination with...
ORYZON to Provide Corporate Progress Updates at Several Events in February-March Keystone Symposia Epigenetic Mechanisms and Cancer TreatmentBio-Neuroscience17th Annual European Life Sciences CEO Forum BIO-Europe Spring 2024 MADRID, Spain and BOSTON, Feb. 05, 2024 (GLOBE NEWSWIRE) -- Oryzon Genomics, S.A. (ISIN Code: ES0167733015, ORY), a clinical-stage biopharmaceutical company leveraging epigenetics to develop therapies in diseases with strong unmet medical need, announced today that its management will give an update on corporate progress at several international events in February an...
Oryzon hosted a key opinion leader (KOL) event highlighting the potential of vafidemstat in borderline personality disorder (BPD). The KOLs discussed the limited options for treating BPD, as there are no approved drugs, and the current therapies are often ineffective. While the PORTICO trial did not reach statistical significance on its primary endpoints, vafidemstat was favoured over placebo in all efficacy measures, with statistical significance in two key secondary endpoints. During the event...
ORYZON to Host KOL Event on Phase IIb PORTICO Topline Study Results of Vafidemstat in Borderline Personality Disorder on January 25, 2024 MADRID, Spain and BOSTON, Jan. 19, 2024 (GLOBE NEWSWIRE) -- Oryzon Genomics, S.A. (ISIN Code: ES0167733015, ORY), a clinical-stage biopharmaceutical company leveraging epigenetics to develop therapies in diseases with a strong unmet medical need, today announced that it will host a virtual KOL event on Thursday, January 25, 2024 at 10:00 am ET to briefly review, then discuss the topline results from the Phase IIb PORTICO study evaluating vafidemstat in ...
Oryzon Genomics has announced top-line results for the Phase IIb trial (PORTICO) assessing vafidemstat in borderline personality disorder (BPD), and while the primary endpoints (Borderline Personality Disorder Checklist (BPDCL) and Clinical Global Impression – Severity Agitation/ Aggression (CGI-S A/A)) did not reach statistical significance, vafidemstat was favoured over placebo in all efficacy measures, with nominal statistical significance in two key secondary endpoints (Borderline Evaluation...
ORYZON Announces Topline Results from Phase IIb PORTICO Study of Vafidemstat in Borderline Personality Disorder (BPD) Company to host Conference Call and live Webcast on Sunday, January 7, 2024 at 5:30 pm PT. An executive summary of the data to be presented at the 7th Sachs Annual Neuroscience Innovation Forum, on January 7 at 3:30 pm PT, at the Marine’s Memorial Club in San Francisco (USA). Results across all efficacy endpoints consistently favored vafidemstat over placebo. Global Statistical Test (GST p-values) confirms consistent trend across efficacy endpointsThe primary endpoints...
ORYZON to Provide Corporate Progress Updates at Several Events in January 7th Sachs Annual Neuroscience Innovation Forum13rd Annual LifeSci Advisors Corporate Access EventBiotech Showcase-2024 42nd Annual J.P. Morgan Healthcare ConferenceInvest Securities Biomed Forum 2024 MADRID, Spain and BOSTON, Jan. 03, 2024 (GLOBE NEWSWIRE) -- Oryzon Genomics, S.A. (ISIN Code: ES0167733015, ORY), a clinical-stage biopharmaceutical company leveraging epigenetics to develop therapies in diseases with strong unmet medical need, announced today that its management will give an update on corporate progre...
Oryzon has announced the receipt of a $0.5m grant from the Amyotrophic Lateral Sclerosis (ALS) Association to support the regulatory clinical development of the company’s histone deacetylase 6 (HDAC6) inhibitor, ORY-4001, as a potential treatment for ALS. We view this as a favourable advancement that enables the company to expand its preclinical pipeline. This news of this funding grant follows on the heels of Oryzon’s recently announced €45m convertible financing arrangement. Oryzon plans to pr...
ORYZON Awarded with a Grant for ORY-4001 From the ALS Association in the U.S. To explore Oryzon’s clinical candidate ORY-4001 in ALS The ALS Association to provide 500,000 USD funding MADRID, Spain and BOSTON, Dec. 04, 2023 (GLOBE NEWSWIRE) -- Oryzon Genomics, S.A. (ISIN Code: ES0167733015, ORY), a clinical-stage biopharmaceutical company leveraging epigenetics to develop therapies in diseases with a strong unmet medical need, announced today the start of a preclinical collaboration with the ALS Association. The Association has awarded Oryzon a 498,690 USD grant through its Lawrence and ...
Oryzon has secured funding of up to €45m through a revised convertible bond financing agreement with Nice & Green, a Switzerland-based institutional investor, which is anticipated to extend Oryzon’s cash runway to end-FY25. The new agreement supplants the previous €20m convertible bond agreement with Nice & Green, out of which €8m was pending withdrawal. We consider this announcement to be a critical development, especially in light of the overall macroeconomic environment. Management is expecte...
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