Geron's RYTELO nears EU approval for certain blood cancers

Published 13/12/2024, 11:42
GERN
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The approval of RYTELO would not only provide a new treatment option but also potentially extend and improve the quality of life for patients with these types of blood cancers. While the company awaits the EC's final decision, it remains committed to optimizing the value and access of RYTELO in select European markets. Analyst sentiment remains strongly bullish, with price targets ranging from $5.50 to $10 per share. For deeper insights into Geron (NASDAQ:GERN)'s financial health and growth prospects, including 10 additional ProTips and comprehensive valuation metrics, explore the full analysis available on InvestingPro. Analyst sentiment remains strongly bullish, with price targets ranging from $5.50 to $10 per share. For deeper insights into Geron's financial health and growth prospects, including 10 additional ProTips and comprehensive valuation metrics, explore the full analysis available on InvestingPro. The European Commission (EC) is set to make a final decision on the marketing authorization in the coming months.

The CHMP's positive opinion is pivotal for Geron, which aims to provide RYTELO as a new treatment option for adult patients with transfusion-dependent anemia due to certain types of myelodysplastic syndromes (MDS) who have not responded well to other therapies. RYTELO, if approved, would be the first telomerase inhibitor available in Europe for this indication.

The approval of RYTELO would not only provide a new treatment option but also potentially extend and improve the quality of life for patients with these types of blood cancers. While the company awaits the EC's final decision, it remains committed to optimizing the value and access of RYTELO in select European markets. Analyst sentiment remains strongly bullish, with price targets ranging from $5.50 to $10 per share. For deeper insights into Geron's financial health and growth prospects, including 10 additional ProTips and comprehensive valuation metrics, explore the full analysis available on InvestingPro.

Geron's Chairman and CEO, John A. Scarlett, M.D., acknowledged the contributions of patients, caregivers, and investigators throughout the EU in the clinical development of RYTELO. He emphasized the significance of the CHMP's positive opinion as a step towards meeting the unmet needs of patients with lower-risk MDS, a group that often progresses to require more intensive management of anemia and fatigue.

The approval of RYTELO would not only provide a new treatment option but also potentially extend and improve the quality of life for patients with these types of blood cancers. While the company awaits the EC's final decision, it remains committed to optimizing the value and access of RYTELO in select European markets.

This article is based on a press release statement from Geron Corporation.

In other recent news, Geron Corporation has been under the spotlight following a series of significant developments. The company's third quarter of 2024 was marked by the successful launch of RYTELO, generating a substantial $28.2 million in net product revenue, demonstrating high market demand. Total (EPA:TTEF) net revenues reached $28.3 million, indicating a noteworthy increase from the previous year.

Stifel recently reaffirmed its Buy rating for Geron, maintaining an $8.00 stock price target. The endorsement followed presentations at the American Society of Hematology (ASH) meeting, showcasing data on Geron's product candidate, Imetelstat, marketed as Rytelo. The data from the IMerge development program demonstrated that Imetelstat's efficacy is indifferent to patients' prior treatments, even for those heavily transfused with lower-risk myelodysplastic syndromes (LR-MDS) who had previously received luspatercept.

New data from the IMerge clinical trial indicates that Imetelstat may be beneficial for patients with LR-MDS with transfusion-dependent anemia, regardless of their previous treatments. The findings suggest that Imetelstat's clinical activity aligns with previous results from the IMerge Phase 3 pivotal trial. Analysts predict substantial revenue growth of over 310% for the coming year, reflecting the market potential of this treatment.

Finally, Geron is preparing for potential EU marketing authorization and launch of RYTELO by 2026. Despite not providing specific financial guidance for future quarters or fiscal years, the company remains optimistic about RYTELO's market potential and aims to establish it as a standard treatment for lower-risk MDS.

This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.

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