Shares in Geron Corp (NASDAQ:GERN) raced up almost 10% to US$2.26 before the bell in New York on FDA news.
The key Food and Drug Administration (FDA) has granted what's called 'fast track' status to the pharma firm's candidate imetelstat.
The program is designed to expedite the review of new drugs that are intended to treat serious conditions and can demonstrate the potential to address an unmet medical need.
Imetelstat is used to treat adults with transfusion-dependent anemia due to low or intermediate risk myelodysplastic syndromes (MDS) - a group of cancers.
It is a telomerase inhibitor initially developed by Geron and exclusively licensed to Janssen Biotech Inc. (Janssen) worldwide.
Janssen sponsored the application for Fast Track designation using preliminary data from IMerge, the ongoing clinical trial being conducted by Janssen in lower risk MDS.