Geron (GERN) Said FDA Places Clinical Hold on GRNOPC1
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Geron Corporation (Nasdaq: GERN) received verbal notice from the FDA that the company's Investigational New Drug submission for GRNOPC1, a cell therapy for spinal cord injury, has been placed on clinical hold.
A clinical hold is an order that the FDA issues to a sponsor to delay a proposed trial or to suspend an ongoing investigation.
Geron CEO, Thomas Okarma, Ph.D., M.D., said, "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. Once we have the letter and have had a discussion with the agency, we will communicate our findings and our thinking to shareholders. We are disappointed with this action given the interactions we had with the FDA over four years leading to the filing, and the breadth and depth of the submission, some 21,000 pages, predicated on those discussions with the agency."
Shares of Geron are currently halted.
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