What are the latest updates on RYTELO's commercial launch, market penetration, and prescriber adoption since June 2024?

Geron Corporation's RYTELO (imetelstat) commercial launch in the U.S. began in June 2024, following FDA approval for adult patients with lower-risk myelodysplastic syndromes (MDS) with transfusion-dependent anemia. The company has provided several updates on its commercial progress since then.

Here's a summary of RYTELO's commercial launch, market penetration, and prescriber adoption:

• Sales Performance:

• In the second quarter of 2025, RYTELO generated approximately $49.0 million in net product revenue, a 24% increase compared to the first quarter of 2025.

• Net product revenue in the first quarter of 2025 was $39.4 million.

• In the fourth quarter of 2024, net product revenue was $47.5 million, bringing the total since launch (end of June 2024) to $76.5 million.

• The company noted that weekly sales growth was relatively flat since the end of Q4 2024 and continued into Q1 2025, leading to lower Q1 2025 revenue compared to Q4 2024. However, demand increased by 17% quarter-over-quarter in Q2 2025, driven by new patient starts.

• Market Penetration and Prescriber Adoption:

• Geron's priority is to drive new patient starts across the eligible patient population.

• The number of ordering accounts for RYTELO has surpassed 1,000, an increase of approximately 400 year-to-date as of Q2 2025.

• The company's strategy to drive sales growth focuses on increasing brand awareness, expanding its commercial and medical field forces, refining marketing efforts to enhance prescribing clarity, and implementing programs to expand key opinion leader support.

• Despite these efforts, the company acknowledges that meaningful sales growth is not assured, and market penetration rates may be lower than expectations.

• European Expansion:

• RYTELO received a positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) in December 2024, recommending its approval.

• The European Commission granted marketing authorization for RYTELO in Q1 2025.

• Geron is preparing to commercialize RYTELO in select EU countries starting in 2026.

Geron emphasizes that RYTELO is its only approved product, and its ability to generate meaningful revenue and achieve profitability is wholly dependent on its successful commercialization in the U.S. and potential expansion into other indications or geographies. The company expects its operating expenses for 2025 to be between $270 million and $285 million, reflecting continued investment in RYTELO's commercialization strategy and preparations for the EU launch.