Geron’s FDA-Approved Rytelo Forecasted to Reach $2.7 Billion in Peak Sales by 2035

On June 6, 2024, the U.S. Food and Drug Administration (FDA) approved Geron’s (NASDAQ: GERN) Rytelo (imetelstat) for the treatment of myelodysplastic syndromes (MDS), a group of bone marrow disorders. Rytelo is specifically indicated for adults with low- to intermediate-risk MDS and transfusion-dependent anemia who have either not responded to, lost response to, or are ineligible for erythropoiesis-stimulating agents (ESAs). This approval is a significant milestone for Geron, marking its first drug approval in 33 years.

According to Visible Alpha estimates, Rytelo is expected to generate $54 million in revenue in 2024, with sales potentially peaking at $2.1 billion by 2035. Geron is also conducting phase 3 trials of imetelstat for myelofibrosis (MF), another bone marrow cancer. However, data from the IMpactMF trial, originally expected in 2024, has been delayed until 2026 due to lower-than-expected patient enrollment and mortality rates. Analysts project revenue from MF treatments to reach $98 million by 2028, growing to $788 million by 2035. Overall, Rytelo’s revenue is expected to grow to $244 million by 2025, with global peak sales forecasted at $2.7 billion by 2035.