Oryzon Genomics S.A (ORY) | News Based Sentiment Analysis

• On September 4, 2025, Oryzon Genomics received a significant boost with the European Medicines Agency (EMA) granting a Clinical Trial Application (CTA) to initiate a Phase Ib study of iadademstat in sickle cell disease (SCD). This marks the first time iadademstat is being investigated for a non-malignant hematological indication, potentially opening up a $3 billion (2025) market, projected to grow to $8 billion by 2032.
• Building on the September 4th CTA approval, Oryzon is actively diversifying its pipeline, highlighting iadademstat’s existing orphan drug designations for Acute Myeloid Leukemia (AML) and small-cell lung cancer. They are also planning a clinical trial for iadademstat in essential thrombocythemia, demonstrating a broader strategic vision.
• Analysts are taking notice, with Edison Group publishing a report titled "Oryzon Genomics - Foray into sickle cell disease" on August 26, 2025, following the initial EMA approval on August 25, 2025. This signals growing external interest in Oryzon’s expansion into new therapeutic areas.
• Investor sentiment appears to be shifting, as indicated by Morningstar’s quantitative stock rating update on August 26, 2025, though specifics weren’t disclosed. Investors should monitor how the market is valuing Oryzon following the SCD study approval.
• Oryzon successfully completed a €30 million capital increase on September 4, 2025, issuing 12.76 million new shares at €2.35 per share, a 15.44% discount to the VWAP and 19.38% discount to the closing price on April 22, 2025. A U.S.-based institutional investor anchored the round with a €15 million order, and the offering was oversubscribed.
• Looking ahead, Oryzon anticipates regulatory clearance from the FDA for vafidemstat's Phase III PORTICO-2 trial in Borderline Personality Disorder (BPD) sometime in September 2025. Additionally, approval for a new Phase Ib trial (RESTORE) evaluating iadademstat in sickle cell disease, enrolling 40 patients, is expected this month.
• The company is scheduled to release its next earnings report on October 22, 2025, with a current revenue forecast of 0.00 and a trailing twelve months (TTM) Earnings Per Share (EPS) of -0.06.
• Analysts currently have an average 12-month price target of 6.78333 EUR for Oryzon Genomics (as of September 13, 2025), with estimates ranging from 4 EUR to 12 EUR, suggesting a potential upside of +147.57% to +150.31% from current levels.

The Investment Story: September was a month of significant progress for Oryzon Genomics, marked by pipeline diversification, successful fundraising, and growing analyst attention. The company is actively expanding iadademstat’s applications and preparing for key clinical trial milestones.

What It Means for Investors: The expansion into SCD and the successful capital raise provide Oryzon with resources and opportunities for growth. While early-stage drug development carries inherent risks, the positive momentum and increasing analyst coverage could drive investor confidence.

Looking Ahead: Investors should closely monitor updates from the Phase Ib SCD study, the FDA clearance for the vafidemstat trial, and the earnings report on October 22, 2025. The presentation at the American Society of Hematology meeting in December 2025 will also be a crucial event.

The Bottom Line: Oryzon Genomics is demonstrating promising progress with its pipeline diversification and financial stability. The SCD opportunity is particularly exciting, but investors should remain mindful of the risks associated with clinical trials and the company’s current lack of profitability.