Geron Corporation (NASDAQ:GERN) saw its shares soar 6.2% in pre-market trading on Thursday, following the company's better-than-expected fourth-quarter 2024 financial results and positive updates on its flagship product, Rytelo.
The biopharmaceutical company reported a strong performance for Rytelo, its first-in-class telomerase inhibitor approved for the treatment of lower-risk myelodysplastic syndromes (MDS). Here are the key highlights:
Rytelo's Commercial Progress:
- Rytelo achieved $47.5 million in net product revenue in Q4 2024, exceeding internal expectations.
- The drug received favorable placement in the MDS NCCN guidelines, including a Category 1 treatment recommendation for second-line patients, regardless of prior therapy.
- While most new patient starts have been in the third-line plus segment, Geron is focused on driving adoption across all eligible lines of therapy, particularly in the high unmet need ESA relapsed/refractory RS-negative population.
Myelofibrosis Clinical Development:
- The Phase III IMpactMF trial for imetelstat in relapsed/refractory myelofibrosis is 80% enrolled, with an interim analysis expected in the second half of 2026.
- A positive outcome could potentially double Rytelo's commercial opportunity by transforming the treatment landscape for this underserved patient population.
Financial Position:
- Geron ended 2024 with approximately $503 million in cash, cash equivalents, and marketable securities.
- The company expects to reach profitability without additional financing if its internal sales and operating expense expectations are met.
While Geron acknowledged challenges in driving new patient starts in earlier lines of therapy, the company remains focused on increasing awareness and education among healthcare providers. Key opinion leaders who have experience with Rytelo have provided positive feedback, reinforcing the drug's potential as a standard of care in lower-risk MDS.