FDA Staff Reviewers Say Treatment With Geron's Anemia Drug Imetelstat Is Associated With Risks That Might Be Considered Substantial; It Is Not Clear That Risks Of Treatment With Imetelstat Are Outweighed By The Potential Benefit For The Intended Population; The Patient-Reported Outcomes Are Not Supportive Of Geron's Treatment Effect
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FDA staff reviewers have expressed concerns about Geron's anemia drug Imetelstat, citing substantial risks associated with its treatment. They indicated that it's unclear if the benefits outweigh the risks for the intended population, and patient-reported outcomes do not support the treatment effect of Imetelstat.
March 12, 2024 | 1:38 pm
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FDA staff reviewers have raised concerns about the safety and efficacy of Geron's anemia drug Imetelstat, questioning the balance of risks and benefits.
The FDA's concerns about Imetelstat's safety and efficacy directly impact Geron's prospects, as regulatory approval is crucial for the drug's commercial success. Negative feedback from FDA staff reviewers can lead to a decline in investor confidence and potentially affect the stock price negatively in the short term.
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RELEVANCE 100