reports
- Sean Conroy
Oryzon Genomics - Q3 results recap key upcoming inflection points
Oryzon has reported its Q324 results, the highlight of which was the borderline personality disorder (BPD) programme, with the final Phase IIb PORTICO data demonstrating vafidemstat’s potential to offer meaningful results in a condition with no approved drugs currently. A further boost was the positive FDA feedback for Phase III, and the next step will be the submission of a full trial protocol for PORTICO-2 (expected in Q125). Oryzon also made strides in strengthening its intellectual property ...
ORYZON Reports Financial Results and Corporate Update for Quarter Ende...
ORYZON Reports Financial Results and Corporate Update for Quarter Ended September 30, 2024 Final data from PORTICO, global Phase IIb vafidemstat trial in BPD, presented at the 37th ECNP annual conference in SeptemberCompany moving forward with PORTICO-2 Phase III trial preparations following positive feedback from End-of-Phase II meeting with the FDA Company continues to strengthen IP position for vafidemstat with additional “intention to grant” communications First cohort dosed in Investigator-initiated Phase Ib study of iadademstat with venetoclax and azacitidine in first-line AMLReductio...
- Sean Conroy
Oryzon Genomics - FDA aligns on Phase III BPD plans
Oryzon Genomics has confirmed the FDA’s alignment with its proposed Phase III programme for vafidemstat in borderline personality disorder (BPD). Notably, the FDA acknowledged agitation and aggression (A/A) as a therapeutic indication and, as such, the State-Trait Anger Expression Inventory 2 (STAXI-2) Trait Anger may be used as a primary endpoint for Phase III (PORTICO-2). We note that vafidemstat showed statistically significant benefit by this measure in the prior Phase IIb PORTICO trial. We ...
ORYZON receives minutes from End-of-Phase II meeting with the FDA on t...
ORYZON receives minutes from End-of-Phase II meeting with the FDA on the PORTICO-2 Phase III vafidemstat trial in Borderline Personality Disorder FDA’s feedback supports the initiation of the Phase III trialAgitation-Aggression in Borderline Personality Disorder (BPD) acknowledged as a possible therapeutic indicationOryzon may use STAXI-2 Trait anger as a primary efficacy endpoint for PORTICO-2Currently no FDA-approved treatments for BPD Company to host conference call and live webcast today at 09:00 am EDT (15:00 pm CET) MADRID and CAMBRIDGE, Mass., Oct. 01, 2024 (GLOBE NEWSWIRE) -- Ory...
- Sean Conroy
Oryzon Genomics - Final PORTICO data reaffirms potential in BPD
Oryzon has presented the results of the final analysis from the Phase IIb PORTICO trial, which evaluated the efficacy and safety of vafidemstat in borderline personality disorder (BPD). While top-line results were initially published in January, the final data (presented at the 37th ECNP 2024 congress) show notable improvements across key efficacy measures, reaffirming the potential of the candidate to deliver meaningful benefits to patients with BPD, a highly underserved condition with no appro...
ORYZON Presents the Final Data From PORTICO, a Global Phase IIb Vafide...
ORYZON Presents the Final Data From PORTICO, a Global Phase IIb Vafidemstat Trial in Borderline Personality Disorder (BPD), at the European College of Neuropsychopharmacology (ECNP) Congress Strong improvement in State-Trait Anger Expression Inventory 2 (STAXI-2) Trait Anger, a measure of agitation and aggression, at Weeks 8–12 compared to previous top line data; nominal statistical significance now of p = 0.0071Improvement in Borderline Evaluation of Severity (BEST), an overall measure of BPD disease severity, at Weeks 8–12 compared to previous top line data; nominal statistical significan...
ORYZON Receives “Intention to Grant” Communication for Patent Relating...
ORYZON Receives “Intention to Grant” Communication for Patent Relating to the Use of Vafidemstat in Borderline Personality Disorder From the European Patent Office MADRID and CAMBRIDGE, Mass., Sept. 11, 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 application EP20712565.9 entitled “Methods of tr...
- Sean Conroy
Oryzon Genomics - First patient dosed in new AML combination study
Oryzon Genomics has announced the commencement of patient dosing in the investigator-initiated Phase Ib trial evaluating iadademstat as a combination treatment in first-line acute myeloid leukemia (AML). The study, which aims to recruit c 24 patients, is sponsored by Oregon Health & Science University (OHSU). It is designed to evaluate the safety, tolerability and optimal dose of iadademstat when administered alongside standard-of-care treatments venetoclax and azacitidine. It will also test for...
ORYZON Announces First Patient Dosed in an Investigator-Initiated Phas...
ORYZON Announces First Patient Dosed in an Investigator-Initiated Phase Ib Study of Iadademstat in First-Line Acute Myeloid Leukemia Exploring the triple combination with venetoclax and azacitidineStudy sponsored by Oregon Health & Science University (OHSU) MADRID and CAMBRIDGE, Mass., Sept. 09, 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 first patient has been dosed in an investigator-initiated P...
ORYZON Continues to Strengthen its Patent Portfolio for Vafidemstat wi...
ORYZON Continues to Strengthen its Patent Portfolio for Vafidemstat with Additional “Decision to Grant” Communications In Australia, Malaysia and Mexico MADRID and CAMBRIDGE, Mass., Sept. 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 it has received additional “Decision to grant” communications for important patents relating vafidemstat, Oryzon’s LSD1 inhibitor in clinical development for the treatme...
ORYZON to Provide Corporate Progress Updates at Several Events in Sept...
ORYZON to Provide Corporate Progress Updates at Several Events in September German Fall Conference 2024European College of Neuropsychopharmacology (ECNP) congress 2024Sachs Annual Biotech in Europe Forum 2024 MADRID, Spain and CAMBRIDGE, Mass., Aug. 29, 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 September. Oryzo...
- Jamila El Bougrini
- Thibaut Voglimacci-Stephanopoli
- Sean Conroy
Oryzon Genomics - Multiple milestones anticipated in H224
Oryzon’s Q224 results summarised an active quarter for its clinical pipeline, with multiple milestones expected in H224. Central to the H224 momentum will be the upcoming FDA end-of-Phase II (EoP2) meeting for vafidemstat in BPD, for which a positive outcome would provide impetus to subsequent plans. Interim data from FRIDA (iadademstat in AML) was encouraging, and with several additional combination trials planned, the second half of the year will continue to be highly active. Operating results...
ORYZON reports financial results and corporate update for half-year en...
ORYZON reports financial results and corporate update for half-year ending June 30, 2024 Company granted an End-of-Phase II meeting with the FDA to discuss plans for a registrational Phase III trial with vafidemstat in Borderline Personality Disorder (BPD)Final data from PORTICO, global Phase IIb vafidemstat trial in BPD, scheduled as an oral presentation at the 37th ECNP annual conference in SeptemberCompany continues to strengthen IP position in CNS with formal notices of intention to grant two patent applications in Japan covering the use of vafidemstat to treat BPD and Attention Deficit...
- Sean Conroy
Oryzon Genomics - Strengthening vafidemstat’s IP profile
Oryzon Genomics continues to fortify its IP profile for vafidemstat, which is being developed for borderline personality disorder (BPD) and for the potential application to attention deficit hyperactivity disorder (ADHD). Oryzon has received positive acceptance decisions for two incremental patent applications from the Japanese Patent Office (JPO), which should provide protection until 2040 (excluding potential extensions). Oryzon was also notified of similar patent grants from the European and ...
ORYZON Receives “Decision to grant” for Two Important Patents for Vafi...
ORYZON Receives “Decision to grant” for Two Important Patents for Vafidemstat in Japan For the treatment of Borderline Personality Disorder (BPD) and Attention Deficit Hyperactivity disorder (ADHD) MADRID and CAMBRIDGE, Mass., July 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 it has received “Decision to grant” communications from the Japanese Patent Office (JPO) for two Japanese patent applications ...
ORYZON Announces Voting Results from its 2024 Annual General Meeting o...
ORYZON Announces Voting Results from its 2024 Annual General Meeting of Shareholders All resolutions were approvedAdditional resolution to increase capital for up to 100 million euros approved42.6867% of the issued shares represented MADRID and CAMBRIDGE, Mass., June 28, 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, announced the voting results from its Annual General Meeting of Shareholders held today in Madrid. A total of ...
ORYZON Announces Presentation of Final Data From PORTICO, Vafidemstat’...
ORYZON Announces Presentation of Final Data From PORTICO, Vafidemstat’s Global Phase IIb Trial in Borderline Personality Disorder, at the 37th ECNP Annual Conference Selected for oral presentationConference will be held in Milan on September 21-23 MADRID and CAMBRIDGE, Mass., June 26, 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, today announced that it will present final data from its Phase IIb PORTICO trial, which investigat...
- Jamila El Bougrini
- Thibaut Voglimacci-Stephanopoli
ORYZON Presents Preliminary Data From Ongoing Phase Ib FRIDA Trial wit...
ORYZON Presents Preliminary Data From Ongoing Phase Ib FRIDA Trial with Iadademstat Plus Gilteritinib in Relapsed/Refractory FLT3-mut AML Patients at EHA-2024 Data from the first two cohorts demonstrated that combination of iadademstat plus gilteritinib was safe and showed strong antileukemic activityA third cohort is ongoing following FDA’s OPTIMUS guidance MADRID and CAMBRIDGE, Mass., June 14, 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...
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