Geron's spinal injury drug application on clinical hold Print E-mail
By Wire Reports   
Tuesday, 18 August 2009 12:09
Stem cell research company Geron Corp (Nasdaq:GERN) said U.S. health regulators have placed a clinical hold on its investigational new drug application for a cell therapy to treat subacute spinal cord injury, sending its shares down as much as 14 percent.

The U.S. Food and Drug Administration placed the application on hold to review new nonclinical animal study data submitted by Geron.

The company submitted new data to the FDA after performing additional product characterization and conducting further animal studies.

"Most of the investor focus has been on this spinal cord injury study over the last several months, but we believe that bulk of the valuation to this company comes from their oncology program," Merriman Curhan Ford analyst Joe Pantginis said by phone.

Currently Geron is developing three different drugs in the field of oncology, including a cancer vaccine Grnvac1, which is in a mid-stage trial, and a cancer drug Grn163l, which is in an early-stage trial.

Pantginis said Geron's spinal cord injury study was more of a headline driver for the company, but certainly not the primary driver.

Shares of the company were trading down 11 percent at $6.39 in morning trade on Nasdaq. They had touched a low of $6.20, making them the top percentage loser on Nasdaq.

(Reporting by Anand Basu in Bangalore; Editing by Jarshad Kakkrakandy, Pradeep Kurup of Reuters)

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