Geron Nosedives as FDA Stops Blood Disorder Drug Development

Biotechnology company Geron Corp, which has no products marketed to date, plummeted after the U.S. Food and Drug Administration halted the development of the company’s only experimental drug for blood disorders imetelstat, due to the possibility of it causing damage to the liver.

The company’s shares plummeted 59% to just $1.79 Wednesday morning. The stock of the company, which is based in Menlo Park, California, had tripled its value over the past 12 months through the end of trading on Tuesday.

The U.S. FDA told the company to put a clinical hold on imetelstat’s mid-stage trials due to low-grade liver function abnormalities. The regulator cited risk potential for chronic liver injury after exposure for a long-term to Geron drug, the company said in a statement on Thursday morning.

The statement by the company said that the U.S. regulator was concerned about whether the abnormalities were reversible. Geron is planning to work hand in hand with the U.S. regulator to seek a release of the new clinical hold.

Last November, Geron released data that showed imetelstat helped those patients suffering from myelofibrosis, a disorder in the bone marrow. That helped send shares soaring the most in the last 10 years.

The U.S. FDA clinical hold applies the studies involving multiple myeloma, polycythemia vera and thrombocythemia. Geron also stated it thought it likely that the mid-stage study planned for myelofibrosis would also be delayed.

One analyst wrote that he would remain on the sidelines currently since Geron has not other medication in the pipeline to fall back on if the FDA were to decide imetelstat was simply unsafe to use.

Geron said it cancelled its conference call for discussion on the financial results from the fourth quarter on Thursday afternoon. It said it would report its financials as part of its regulatory filing, opting instead to make a call during the morning with regard to the action taken by the FDA.