BioCentury
ARTICLE | Clinical News

FDA lifts partial hold on Geron's imetelstat

June 12, 2014 11:32 PM UTC

Geron Corp. (NASDAQ:GERN) jumped $0.55 (21%) to $3.15 on Thursday after FDA lifted a partial clinical hold on an ongoing investigator-sponsored pilot trial of the company's imetelstat ( GRN163L), though the agency is maintaining a full clinical hold on company-sponsored trials of the oligonucleotide that competitively inhibits telomerase activity. FDA placed the holds in March due to a safety signal of hepatotoxicity in trials of the compound (see BioCentury Extra, March 12).

According to Geron, FDA lifted the partial hold on the investigator-sponsored trial of imetelstat to treat myelofibrosis (MF) after the investigator submitted information on the reversibility of hepatotoxicity in patients who received the compound in the trial. The company said it is working with FDA to remove the full hold on company-sponsored trials, but declined to disclose a timeline for when it plans to submit data to the agency. ...