ORY

ORYZON Announces Last Patient Last Visit in its Phase IIb PORTICO Study for Borderline Personality Disorder (BPD)

Retrieved on: 
Tuesday, November 7, 2023

: 2020-003469-20, ClinicalTrials.gov Identifier NCT04932291) is a global double-blind, randomized, placebo-controlled, adaptive 14-week Phase IIb trial evaluating the efficacy and safety of vafidemstat in a BPD population.

Key Points: 
  • : 2020-003469-20, ClinicalTrials.gov Identifier NCT04932291) is a global double-blind, randomized, placebo-controlled, adaptive 14-week Phase IIb trial evaluating the efficacy and safety of vafidemstat in a BPD population.
  • The trial has two primary endpoints: reduction of agitation and aggression and overall disease improvement in BPD severity.
  • The independent Data Monitoring Committee (DMC) has met routinely and reviewed unblinded safety data throughout the PORTICO trial.
  • Our quest on the primary endpoints is replicated in a rich set of secondary endpoints, making PORTICO a very informative trial.

ORYZON to Provide Corporate Progress Updates at Several Events in November

Retrieved on: 
Monday, November 6, 2023

MADRID, Spain and BOSTON, Nov. 06, 2023 (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 November.

Key Points: 
  • MADRID, Spain and BOSTON, Nov. 06, 2023 (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 November.
  • Oryzon will participate in the BIO-Europe 2023 conference, which will be held on November 6-8 at the Trade Fair Center Messe München in Munich (Germany), and virtually on November 14-15.
  • The company will hold one-on-one meetings with pharmaceutical companies and global investors.
  • Click on link for more info about Jefferies 2023 London Healthcare Conference

ORYZON Reports Financial Results and Corporate Updates for Quarter Ended September 30, 2023

Retrieved on: 
Friday, October 27, 2023

Dr Carlos Buesa, Oryzon’s Chief Executive Officer, said: “Oryzon continued with a strong path in its clinical programs in the third quarter.

Key Points: 
  • Dr Carlos Buesa, Oryzon’s Chief Executive Officer, said: “Oryzon continued with a strong path in its clinical programs in the third quarter.
  • The company has started a structured dialogue with corporate pharma to identify a suitable partner to move forward the asset to Phase III, pending positive results.
  • General and administrative expenses were $0.7 and $2.9 million for the quarter and nine months ended September 30, 2023, respectively, compared to $0.7 and $3.3 million for the quarter and nine months ended September 30, 2022.
  • Net losses were $0.8 and $3.4 million for the quarter and nine months ended September 30, 2023, respectively, compared to $0.7 and $3.9 million for the quarter and nine months ended September 30, 2022.

ORYZON presents blinded aggregate safety data from vafidemstat’s ongoing Phase IIb PORTICO trial in Borderline Personality Disorder

Retrieved on: 
Tuesday, October 10, 2023

Oryzon presented a poster communication entitled “PORTICO – Double-blind, randomized placebo-controlled, adaptive phase IIb trial with vafidemstat in borderline personality disorder – aggregated baseline characteristics, demographics and safety”, which was presented by Dr. Michael Ropacki, Oryzon’s CMO for CNS.

Key Points: 
  • Oryzon presented a poster communication entitled “PORTICO – Double-blind, randomized placebo-controlled, adaptive phase IIb trial with vafidemstat in borderline personality disorder – aggregated baseline characteristics, demographics and safety”, which was presented by Dr. Michael Ropacki, Oryzon’s CMO for CNS.
  • The data presented at ECNP-2023 correspond to the analysis of aggregated blinded safety data cut as of August 23, 2023.
  • As of September 2023, PORTICO randomized 210 participants, and 131 of the originally planned participants (N = 150) already completed the trial.
  • : 2020-003469-20, ClinicalTrials.gov Identifier NCT04932291) is a global double blind, randomized, placebo-controlled, adaptive 14-week Phase IIb trial evaluating the efficacy and safety of vafidemstat in a BPD population.

ORYZON Receives Two Grants to Further Explore the Role of Epigenetic Targets in the Treatment of Neuronal Pathologies

Retrieved on: 
Tuesday, October 3, 2023

The plan is funded by the Spanish State Research Agency and the Ministry of Science and Innovation within the framework of the recovery, transformation and resilience plan financed by the European Union (NextGenerationEU).

Key Points: 
  • The plan is funded by the Spanish State Research Agency and the Ministry of Science and Innovation within the framework of the recovery, transformation and resilience plan financed by the European Union (NextGenerationEU).
  • The DICTIONIS Project will be carried out in collaboration with the Fundació Centre de Regulació Genomica from Barcelona (Spain) and focuses on the diagnosis of chromatinopathies by detecting alterations in histone modifications.
  • Both projects started on April 1, 2023 and will have a duration of two years.
  • The projects have an overall budget of €2.3 million euros, of which Oryzon will receive approximately a €1.35 million aid and an additional grant to hire two Ph.D.s.

ORYZON to Provide Corporate Progress Updates at Several Events in October

Retrieved on: 
Monday, October 2, 2023

Oryzon will participate in the East-West Biopharma Summit, which will be held on October 2-4 in Kendall Square, Cambridge Mass.

Key Points: 
  • Oryzon will participate in the East-West Biopharma Summit, which will be held on October 2-4 in Kendall Square, Cambridge Mass.
  • (USA), and virtually.
  • The company will provide a corporate update and will also hold one-on-one meetings with US and Chinese pharmaceutical companies and investors.
  • Click on link for more info about the ESMO 2023 congress

ORYZON to Give Updates on Corporate Progress in September

Retrieved on: 
Tuesday, September 5, 2023

Oryzon will participate at the H.C. Wainwright Global Investment Conference, which will be held on September 11-13 at the Lotte New York Palace Hotel in New York (USA) and virtually.

Key Points: 
  • Oryzon will participate at the H.C. Wainwright Global Investment Conference, which will be held on September 11-13 at the Lotte New York Palace Hotel in New York (USA) and virtually.
  • The company will provide a corporate update and will also hold one-on-one meetings with pharmaceutical companies and global investors.
  • Additionally, the company will present during the poster session the data obtained in a CMT experimental model with its selective HDAC6 inhibitor ORY-4001.
  • Executive directors of the company will attend BIO-Spain 2023, which will take place on September 26-28 in Barcelona, Spain.

Oryzon Announces Completed Patient Recruitment in the PORTICO Phase IIb Trial of vafidemstat in Borderline Personality Disorder

Retrieved on: 
Wednesday, July 26, 2023

: 2020-003469-20, ClinicalTrials.gov Identifier NCT04932291) is a global double blind, randomized, placebo-controlled, adaptive 14-week Phase IIb trial evaluating the efficacy and safety of vafidemstat in a BPD population.

Key Points: 
  • : 2020-003469-20, ClinicalTrials.gov Identifier NCT04932291) is a global double blind, randomized, placebo-controlled, adaptive 14-week Phase IIb trial evaluating the efficacy and safety of vafidemstat in a BPD population.
  • The trial has multiple primary endpoints: reduction of agitation and aggression and overall disease improvement in BPD severity.
  • “We are entering a very exciting period for Oryzon as we are approaching topline readout from the first randomized Phase IIb clinical trial investigating vafidemstat” said Dr. Carlos Buesa, Chief Executive Officer at Oryzon.
  • Current safety data of PORTICO are aligned with previous vafidemstat trials and continue to support that vafidemstat is safe and well-tolerated.

Positive Aggregate Safety Data From Vafidemstat’s Ongoing Phase IIb PORTICO Trial in Borderline Personality Disorder

Retrieved on: 
Wednesday, July 5, 2023

MADRID, Spain and BOSTON, July 05, 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, today reports new preliminary blinded aggregate safety data from its ongoing Phase IIb PORTICO trial, investigating vafidemstat in Borderline Personality Disorder (BPD).

Key Points: 
  • MADRID, Spain and BOSTON, July 05, 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, today reports new preliminary blinded aggregate safety data from its ongoing Phase IIb PORTICO trial, investigating vafidemstat in Borderline Personality Disorder (BPD).
  • On June 26, 2023, blinded aggregate safety data were reviewed during the recent independent DMC meeting, corresponding to the initial 167 randomized patients (data cut-off, 23 May 2023).
  • The reviewed blinded PORTICO safety data is aligned with aggregated safety data collected from 7 completed vafidemstat clinical trials, in which almost 400 subjects have been treated with the drug.
  • : 2020-003469-20, ClinicalTrials.gov Identifier NCT04932291) is a multicenter, double-blind, randomized, placebo-controlled, Phase IIb trial to evaluate the efficacy and safety of vafidemstat in adult BPD patients.

ORYZON Announces Voting Results from its 2023 Annual General Meeting of Shareholders

Retrieved on: 
Tuesday, June 27, 2023

MADRID, Spain and BOSTON, June 27, 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 voting results from its Annual General Meeting (AGM) of Shareholders held on Monday, June 26, 2023, in Madrid.

Key Points: 
  • MADRID, Spain and BOSTON, June 27, 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 voting results from its Annual General Meeting (AGM) of Shareholders held on Monday, June 26, 2023, in Madrid.
  • A total of 20.009.878 of the issued and outstanding common shares of the Corporation (35,01%) were represented either in person or by proxy at the meeting.
  • The shareholders of the Company approved all resolutions listed below, as proposed by the Board of Directors at the Company's Annual General Meeting, with favorable votes ranging from 90% to 96%.
  • Full details of the resolutions and their independent item voting results may be examined on the Company’s web page and on the Market Regulator’s (CNMV) web page as Other Relevant Information.