Geron Corporation to Present RYTELO Study Data at EHA 2026 Congress
Geron Corporation announced that the first real-world evidence study of RYTELO in patients with lower-risk myelodysplastic syndromes will be presented at the European Hematology Association 2026 Congress. The retrospective and prospective investigator-sponsored study, conducted at the Moffitt Cancer Center, reported safety and clinical efficacy of imetelstat in advanced, heavily transfusion dependent patients with LR-MDS, including patients with extensive prior therapies and after luspatercept failure. Data from the retrospective portion of the study will be presented at the EHA 2026 Congress. The data, from the retrospective portion of the investigator-sponsored study, evaluated imetelstat in 40 patients with lower-risk MDS treated at the Moffitt Cancer Center in a real-world setting following U.S. Food and Drug Administration approval. Patients included in the analysis had advanced, heavily transfusion-dependent disease and extensive prior treatment exposure, including prior luspatercept, erythropoiesis-stimulating agents, hypomethylating agents and lenalidomide. With 14-month follow-up, the analysis reported a red blood cell transfusion independence rate of 37.5% lasting at least eight weeks with several responses ongoing at the time of analysis and identified potential predictors of response. The safety profile observed in the study was generally consistent with the known safety profile of imetelstat. Cytopenias were reported as the most common Grade 3/4 adverse event. Exploratory analyses also suggested a trend toward improved responses when imetelstat was used within the first three lines of therapy. Geron will also have additional presentations at the EHA 2026 Congress and the American Society of Clinical Oncology 2026 Annual Meeting, including abstracts related to its ongoing myelofibrosis clinical programs. This includes an updated overall survival analysis in patients with myelofibrosis treated with imetelstat in the Phase 2 IMbark trial compared with real-world data.
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- Market Potential: The global cell therapy market was valued at approximately $4.7 billion in 2023 and is expected to exceed $20 billion by 2030, indicating strong interest from biotech firms and investors in cellular repair and regeneration therapies.
- Anti-Aging Therapy Progress: Avaí Bio and Austrianova have completed the Master Cell Bank (MCB) of α-Klotho protein-overexpressing cells, marking a significant milestone that will advance clinical trial processes aimed at addressing aging-related diseases through cell therapy.
- Focus on Neurodegenerative Diseases: The neurodegenerative disease treatment market is projected to grow from $58.4 billion in 2025 to nearly $85 billion by 2032, reflecting a surge in investment towards disease-modifying therapies, particularly in Alzheimer's and Parkinson's disease.
- New Clinical Trial Developments: BioAge Labs' BGE-102 demonstrated significant reductions in inflammatory biomarkers in its Phase 1 trial, with plans to initiate a Phase 2 cardiovascular risk trial in the first half of 2026 to further validate its therapeutic potential.
- Clinical Study Results: A study conducted at Moffitt Cancer Center demonstrated that RYTELO® (imetelstat) achieved a 37.5% red blood cell transfusion independence rate in 40 patients with lower-risk myelodysplastic syndromes (LR-MDS), indicating strong safety and efficacy, thereby reinforcing its position as a treatment option.
- Importance of Treatment Sequencing: The research indicated that using RYTELO® within the first three lines of therapy showed a trend towards improved responses, which not only provides critical data support for clinical practice but may also influence future treatment strategies, helping physicians optimize patient care.
- Future Presentation Plans: Geron will present additional findings related to RYTELO® at the EHA 2026 and ASCO 2026 meetings, including updates on clinical programs for myelodysplastic syndromes and acute myeloid leukemia, which will further support the company's ongoing development in the blood cancer sector.
- Market Outlook: With RYTELO® approved in the U.S. and EU, Geron is focused on enhancing its market share among lower-risk MDS patients through further clinical research and marketing efforts, which is expected to yield significant commercial growth potential for the company.
- Earnings Highlights: Geron reported a Q1 GAAP EPS of -$0.01, beating expectations by $0.01, with revenue of $51.84 million, reflecting a 30.9% year-over-year increase and surpassing estimates by $1.25 million, indicating a positive trend in financial performance.
- Demand Growth: RYTELO demand grew by 6% in Q1 2026 compared to Q4 2025, suggesting an increase in product acceptance in the market, which may lay the groundwork for future sales growth.
- Customer Base Expansion: The number of ordering accounts increased by approximately 12% in Q1 2026 to about 1,450, reflecting success in customer acquisition and market penetration strategies.
- Future Outlook: The company expects RYTELO net product revenue for fiscal year 2026 to be in the range of $220 million to $240 million, while total operating expenses are anticipated to be between $230 million and $240 million, demonstrating cautious optimism regarding future financial health.
- Earnings Release Date: Geron Corporation is set to announce its Q1 earnings on May 6 before market open, with a consensus EPS estimate of -$0.02, indicating ongoing challenges in profitability.
- Revenue Growth Expectations: The anticipated revenue for Q1 is $50.59 million, reflecting a 27.8% year-over-year increase, which, despite minimal overall sales growth, may indicate a gradual market acceptance of its products.
- Earnings Forecast Revisions: Over the past three months, EPS estimates have seen one upward revision with no downward adjustments, suggesting cautious optimism among analysts regarding the company's future performance, although revenue estimates have faced four downward revisions, highlighting concerns about revenue growth.
- Market Reaction: Geron has previously missed earnings expectations, resulting in a decline in stock price, and analysts' views on its future performance have become more conservative, reflecting investor skepticism about the company's outlook.
- 2025 Revenue Performance: GERN reported a net revenue of $48 million in Q4 2025, contributing to a total of $184 million for the year, marking a successful first full commercial year for RYTELO, although operating expenses reached $255 million, highlighting profitability challenges.
- Future Revenue Guidance: The company projects RYTELO net revenue for 2026 to be between $220 million and $240 million, reflecting optimistic expectations for market demand, while operating expenses are expected to decrease by $20 million, indicating efforts in cost control.
- Cash Flow and Financial Flexibility: As of December 31, 2025, GERN holds approximately $400 million in cash and equivalents, enhancing the company's financial flexibility to make strategic investments in a competitive market.
- Market Expansion Strategy: GERN is focusing on approximately 8,000 second-line lower-risk MDS patients and plans to enhance market share by refining messaging and targeting high-volume accounts, despite uncertainties surrounding the European market strategy.







