Geron leaps as FDA lifts partial hold on imetelstat trial

US biotech Geron Corp's (Nasdaq: GERN) shares jumped around 27% to $3.31 in early afternoon trading yesterday after the company revealed that the US Food and Drug Administration has removed the partial clinical hold on the investigator-sponsored clinical trial of imetelstat in myelofibrosis, a rare form of blood cancer (Myelofibrosis IST).

The  partial clinical hold was placed in March due to a safety signal of hepatotoxicity that was identified in clinical trials of imetelstat, but was eased later that month. In order to resolve the partial clinical hold, the investigator, Ayalew Tefferi of the Mayo Clinic, Rochester, Minnesota, was required to provide follow-up information regarding reversibility of hepatotoxicity for all patients who received imetelstat in the Myelofibrosis IST. In its letter dated June 11, 2014, the FDA informed the investigator that it had completed the review of his complete response submission and concluded that the Myelofibrosis IST may proceed.

As previously announced, the Myelofibrosis IST ceased enrolling new patients in January 2014, and Mayo Clinic did not cite any safety concerns as the basis for that decision. Previously enrolled patients who are deriving clinical benefit continue to receive treatment with imetelstat.