Long-troubled drug developer Geron is touting what it calls "unprecedented" early results for its lead cancer drug, sending the biotech's share price up as it moves forward with partner Johnson & Johnson.
Days after finally getting the FDA's go-ahead to resume the stop-and-start development of its lead candidate, Geron has signed a deal to cut Johnson & Johnson in on the process, putting the biotech in line for as much as $935 million if all goes according to plan.
After putting up evidence to show that the liver toxicity triggered by its lead drug can be reversed, the FDA has lifted the full hold placed on its lead--and only--cancer drug. And investors responded enthusiastically to the biotech's return to the clinic, boosting shares by 35% in premarket trading.
The FDA has loosened its grip on imetelstat, Geron's in-development blood cancer treatment, lifting a partial clinical hold on a Mayo Clinic-sponsored study of the drug. However, a separate agency hold on the company's own Phase II trials remains in effect, tying Geron's hands with its one and only candidate.
A week after the FDA put a halt to Geron's in-house studies of the cancer drug imetelstat over toxicity concerns, the agency stepped in on a Mayo Clinic-run trial of the same treatment, citing familiar dangers and imposing a partial clinical hold.
Geron is back in the tank. The biotech's shares were in meltdown mode Wednesday morning, plunging about 60% in premarket trading after the company announced that the FDA put its one and only drug imetelstat on a full clinical hold after detecting a risk of long-term liver damage following prolonged exposure to the treatment.
Geron got an early gift from its friends at the Mayo Clinic, as a release of upbeat imetelstat results sent its shares skyward Friday morning, rising as much as 30% in premarket trading on news its myelofibrosis drug triggered complete remission in some patients.
Shares of Geron doubled this morning after the company posted an abstract of promising results from a small study at the Mayo Clinic conducted on imetelstat for myelofibrosis.
After more than a year of not-so-secret negotiations, Geron has finally auctioned off its long-stalled embryonic stem cell pipeline, handing it over to a newly created BioTime subsidiary in exchange for shares.
John Scarlett's plan to reinvent Geron as a developer of new and exciting cancer drugs has slammed into a fresh debacle.