Boston, MA 06/12/2014 (wallstreetpr) – Geron Corporation (NASDAQ:GERN)’s shares are surging in the market by 29.18% after U.S regulators lifted a partial hold on the company’s drug that is intended to treat a rare form of Leukemia. The company is currently developing its imetelstat drug for a form of Leukemia commonly known as Myelofibrosis. The partial hold had been issued on March 2014, as a result, of safety signals being detected on clinical trial.
Reasons behind the Partial Hold
The U.S Food and Drug Administration withdrew the partial hold after Mayo Clinic; the drugs trial sponsor shed more light on the reversibility of the drugs toxic that was found to take place in the liver. Myelofibrosis is a form of bone marrow cancer that normally leads to a severe form of anemia causing fatigue as well as enlarged spleen and the liver.
The FDA had issued a partial hold on the drugs trials after a number of patients under its medications showed low-grade liver function abnormalities. The company was only allowed to use the drug on patients who showed significant improvement under it. The Company’s trials on two other diseases thrombocythemia and myeloma still remain under hold. Geron is thus unable to submit any clinical trial protocols in the U.S.
Dr. Ayalew Requested to Carry out Follow Up
Dr. Ayalew Tefferi of Mayo Clinic was requested to carry out a follow up on the reversibility of hepatotoxicity for all patients who had received imetelstat in Myelofibrosis IST. On a letter to the FDA, Dr. Ayalew concluded that it would be okay for Myelofibrosis IST to proceed. Myelofibrosis IST ceased to enroll new patients as of January 2014 with Mayo Clinic consequently not citing any safety concerns behind the decision.
The lifting of the ban comes as the company’s stock continues to be rated as a “sell” by TheStreet research firm. The rating was prompted by the fact that the company’s revenue fell by 38% but did not hurt the company’s bottom line, as earnings per share increased.
