"This marks the beginning of what is potentially a new chapter in medical therapeutics -- one that reaches beyond pills to a new level of healing: the restoration of organ and tissue function achieved by the injection of healthy replacement cells," Geron CEO, Thomas Okarma (right) said in a statement. Geron shares rose nearly 30% to $6.75 in premarket electronic trading onNasdaq.
The FDA rejected the company's first request to conduct the trial of GRNOPC1, Oligodendroglial Progenitor Cells, putting the trial on hold in May.
"If GRNOPC1 eventually does become the first human Embryonic Stem Cell drug to receive an approved Biologic License Application it could be as important to drug therapy as the discovery of Salvarsan or penicillin," said drug analysts Stephen Brozak and Daniel Mallin of WBB Securities LLC. Salvarssan was the first modern drug, used to treat syphilis early in the last century.
Joel Sendek of Lazard Capital Markets was cautious: "Cellular-based therapies carry substantially more regulatory risk than do traditional small-molecule drugs or protein therapeutics," he said.`
Former President George W. Bush had been at odds with Congress, researchers and advocates for years over the issue and by executive order restricted federal funding of work involving human embryonic stem cells.
President Barack Obama, who succeeded Bush on Tuesday, had been widely expected to rescind that directive. Although the FDA does not make decisions based on politics, the company made the decision public just days after Obama was sworn into office.