Edison Investment Research - Oryzon Genomics (ORY) Oryzon Genomics - Q3 results recap key upcoming inflection points

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Edison Investment Research

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 (IP) profile, extending vafidemstat’s patent protection up to at least 2040. In oncology, the first patient was dosed in the investigator-initiated Phase Ib study of iadademstat with venetoclax and azacitidine in acute myeloid leukaemia (AML). For FRIDA (iadademstat with gilteritinib in AML), the strategic priority in oncology, the next update will be at EHA 2025. Our valuation adjusts to €796m or €12.3/share (from €775m or €12.1/share).

30/10/2024 1 EN

Underlying

Oryzon Genomics

Oryzon Genomics SA is a Spain-based biopharmaceutical company. It is engaged in the field of epigenetic medicine and in the development of therapeutic, biological solutions for cancer and neurodegenerative diseases. The Company's business model focuses on identifying biomarkers that can be translated in new therapeutic targets, as well as on investing in programs, mainly through the development of small molecules for two main indications: cancer and neurodegeneration. The Company develops investigational medicines till proof of concept (POC) phase and then partners the program with pharmaceutical entities, which are able to get the approval from drug agencies to bring these medicines to the patients. It cooperates with Roche. The Company is a subsidiary of Laboratorio Reig Jofre SA.

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ES0167733015 Madrid Stock Exchange Spain

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Edison Investment Research

Edison is an investment research and advisory company, with offices in North America, Europe, the Middle East and AsiaPac. The heart of Edison is our world renowned equity research platform and deep multi-sector expertise. At Edison Investment Research, our research is widely read by international investors, advisors and stakeholders. Edison Advisors leverages our core research platform to provide differentiated services including investor relations and strategic consulting.

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Analysts

Sean Conroy

Other Reports on these Companies

GlobeNewsWire

ORYZON Reports Financial Results and Corporate Update for Quarter Ended September 30, 2024

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...

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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 view the news as encouraging and believe there is a sizeable opportunity for Oryzon to develop an ef...

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Oryzon Genomics - Q3 results recap key upcoming inflection points

ORYZON Reports Financial Results and Corporate Update for Quarter Ended September 30, 2024

Oryzon Genomics - FDA aligns on Phase III BPD plans

Accsys Technologies - Upgrading guidance for the full year

Topps Tiles - Market outperformance again in FY24

Nabaltec - Resilience and margin expansion

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