FDA Approval and Market Launch of RYTELO
RYTELO, a first-in-class telomerase inhibitor, was approved by the FDA in June 2024 and launched in the U.S. for the treatment of lower-risk MDS patients. It achieved $76.5 million in net product revenue by year-end, surpassing internal expectations.
Strong Cash Position
Geron ended the year with approximately $503 million in cash, cash equivalents, restricted cash, and marketable securities, positioning the company to potentially reach profitability without additional financing.
Favorable Regulatory Developments in Europe
The CHMP adopted a positive opinion recommending RYTELO's approval in Europe, with a final decision expected from the European Commission in the first half of 2025.
Pipeline Progress in Myelofibrosis
80% enrollment achieved in the pivotal Phase 3 IMpactMF trial for imetelstat in JAKi relapsed/refractory myelofibrosis, with interim analysis expected in the second half of 2026.