FDA fast track
Posted: Tue Oct 31, 2017 2:06 pm
FDA has granted fast track status. Geron PR highlights possible disease modification via targeting of malignant clone precursors. bp
Nice! Plus the strat of expanded Part 1 of IMerge.
Expanded Part 1 of IMerge is Open for Patient Enrollment
MENLO PARK, Calif., Oct. 31, 2017 (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 potential treatment of adult patients with transfusion-dependent anemia due to Low or Intermediate-1 risk myelodysplastic syndromes (MDS) who are non-del(5q) and who are refractory or resistant to treatment with an erythropoiesis stimulating agent (ESA). Imetelstat is a telomerase inhibitor initially developed by Geron and exclusively licensed to Janssen Biotech, Inc. (Janssen) on a worldwide basis. Janssen sponsored the application for Fast Track designation utilizing preliminary data from IMerge, the ongoing clinical trial being conducted by Janssen in lower risk MDS.
Link: http://ir.geron.com/phoenix.zhtml?c=673 ... ID=2312755