The Foster City, California-based biopharmaceutical firm confirmed the decision on Wednesday, effectively terminating the research program for this specific patient population. While the clinical trial reached a dead end, the company noted that no unexpected safety signals emerged during the investigation, leaving the drug's established safety profile unchanged.
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Geron Abandons Late-Stage Rytelo Trial Over Futility Concerns
The independent data monitoring committee overseeing Geron Corp.’s Phase 3 study of Rytelo has recommended halting the trial, citing a high probability that the drug would fail to meet its primary objective of improving overall survival in patients suffering from relapsed or refractory myelofibrosis.
Following the announcement, trading of Geron shares was suspended during the premarket session. Despite this setback, Rytelo remains approved for use in both the United States and Europe for adults diagnosed with lower-risk myelodysplastic syndromes characterized by anemia.
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