Geron Announces Fast Track Designation Granted to Imetelstat for Relapsed/Refractory Myelofibrosis MENLO PARK, Calif., Sept. 30, 2019 (GLOBE NEWSWIRE) — Geron Corporation (Nasdaq: GERN) today announced that the United States Food and Drug Administration (FDA) has granted Fast Track designation to imetelstat for the treatment of adult patients with Intermediate-2 or High-risk myelofibrosis (MF) whose […]
Essential thrombocythemia, myelofibrosis respond to telomere targeting Treatment with a drug that targets the chromosome-lengthening enzyme telomerase led to hematologic responses in all treated patients with essential thrombocythemia, a preliminary clinical trial showed. In 16 of 18 cases, patients achieved complete hematologic responses with imetelstat. Additionally, seven of eight patients with Janus kinase 2 (JAK2) […]
Geron announces removal of Full Clinical Hold on Imetelstat The full clinical hold on Geron’s sole pipeline candidate, investigation new drug (IND), Imetelstat, has been lifted by the FDA. The company does not intend to conduct further studies or develop imetelstat for the treatment of essential thrombocythemia (ET) or polycythemia vera (PV). The development plan […]
Geron Corp announced today that the partial clinical hold on clinical trials of imetelstat in myelofibrosis has been removed by the FDA. The hold for essential thrombocythemia and polycythemia vera remains. Click here for the full story.
FDA asks Geron to Halt Development of Imetelstat The FDA has placed it’s only pipeline candidate, imetelstat, on full clinical hold. The news sent shares of GERN plunging 61% on March 12, 2014. Geron had submitted an Investigation New Drug (IND) application for imetelstat, but the FDA issued a verbal notice halting the trials. This […]