FDA raises concerns over Geron's imetelstat anemia drug trial data for lower-risk myelodysplastic syndromes, questioning its risks vs benefits.

The FDA raises concerns over Geron's late-stage trial data for anemia drug, imetelstat, used in patients with lower-risk myelodysplastic syndromes. The FDA questions if the drug's risks are outweighed by potential benefits, citing concerns over red blood cell transfusion independence duration and safety issues. Geron seeks approval for the drug to treat transfusion-dependent anemia in adults with low- to intermediate-risk MDS.