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Thursday, March 14, 2024

Geron Gets AdComm Nod for Blood Cancer Therapy

 

  • FDA Oncologic Drugs Advisory Committee voted 12 to 2 in favor of the clinical benefit/risk profile of imetelstat based on results from the IMerge Phase 3 clinical trial
  • There are significant unmet needs across key TD LR-MDS patient populations, including difficult-to-treat subgroups that are underserved by currently available treatment options
  • June 16, 2024 PDUFA target action date for imetelstat NDA for the treatment of TD anemia in adult patients with LR-MDS

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