• Most Popular
  • Most Shared

UPDATE 1-Geron says FDA puts cell therapy drug on clinical hold

Wed May 14, 2008 3:29pm EDT

Stocks

   

(Recasts, adds details)

Stocks  |  Regulatory News  |  Global Markets

May 14 (Reuters) - Geron Corp (GERN.O) said U.S. health regulators placed a clinical hold on its investigational new drug submission for GRNOPC1, a cell therapy for spinal cord injury, sending its shares down 22 percent to their lowest in more than four years.

"We have not yet received a letter from the FDA explaining the decision to place the submission on hold, so we are unable to comment specifically," Chief Executive Thomas Okarma said in a statement.

The biopharmaceutical company said it had received a verbal notice from the U.S. Food and Drug Administration about the clinical hold.

A clinical hold is an order that the FDA issues to delay a proposed trial or to suspend an ongoing investigation.

Shares of the company, which is working to develop therapeutics based on human embryonic stem cells, fell $1.08 to $3.82 in late trade on Nasdaq. (Reporting by Aradhana Aravindan in Bangalore; Editing by Himani Sarkar)



More from Reuters

Photo

Obama says U.S. will pursue plane attackers

KAILUA, Hawaii (Reuters) - A wing of al Qaeda claimed responsibility on Monday for a failed Christmas Day attack on a U.S.-bound passenger plane and President Barack Obama vowed to bring "every element" of U.S. power against those who threaten Americans' safety. | Video

Passengers queue to go through security checks at the departure gate at Gatwick Airport, in southern England December 28, 2009.    REUTERS/Luke MacGregor

Travel headaches after scare

The U.S. is stepping up airline security measures following the Christmas bomb scare. Here's what you can expect.  Full Article | Video 

A man yells at the site of suicide bomb attack on a procession of Shit'ite Muslims commemorating Ashura in Karachi December 28, 2009. Credit: REUTERS/Athar Hussain

"Worse than an infidel"

Dozens killed as suicide bomber attacks Shi'ite Muslim progression in Pakistan despite thousands of security forces on high alert.   Full Article | Video