For Geron Corporation (GERN), 2024 marked a pivotal year with the FDA approval and subsequent commercial launch of Rytelo (imetelstat) in June, targeting low- to intermediate-1 risk myelodysplastic syndromes (MDS) accompanied by transfusion-dependent anemia. This milestone contributed to a 61.1% surge in Geron's shares over the past year, contrasting sharply with a 15.6% decline in the industry.
Rytelo's approval not only marked Geron's first FDA-approved product but also demonstrated strong demand trends, with sales reaching $28.2 million in its first full quarter post-launch, surpassing the company's expectations. The drug addresses a high unmet need in lower-risk MDS, and Geron anticipates sustained demand and momentum for Rytelo.
In December, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency issued a positive opinion recommending Rytelo's approval in the EU, with a decision expected in the first half of 2025. Additionally, Geron is exploring Rytelo's potential in the phase III IMpactMF study for relapsed/refractory myelofibrosis (MF), with early findings suggesting the drug's tolerability in combination with ruxolitinib for MF treatment.
Financially, Geron bolstered its position through a $375 million funding initiative, including a synthetic royalty agreement with Royalty Pharma and a senior secured term loan from Pharmakon Advisors. This financial strategy supports Rytelo's commercial launch in the U.S. and potential EU market entry, alongside ongoing MF studies.
Moreover, Geron's financial outlook has improved, with 2024 loss estimates narrowing from 26 cents to 25 cents per share and 2025 estimates improving from 10 cents to 6 cents per share over the past 60 days. Geron currently holds a Zacks Rank #3 (Hold), indicating a neutral stance in the investment community.
