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.
The Menlo Park, CA-based biotech and BioTime inked a letter of intent, which outlines some of the terms for a BioTime subsidiary to take over Geron's embryonic stem cell programs that were shelved last year as Geron narrowed its focus to cancer drug development.
Back in early 2011 Geron CEO Thomas Okarma was forced to step aside as the biotech prepared to bring in a new CEO to restructure the operations. Now Okarma is back, leading a new regenerative medicine venture set up by BioTime. And he wants his stem cell work back.
Just 10 months after new Geron CEO John Scarlett dumped a decade's worth of stem cell work in favor of a special focus on cancer drugs, the biotech has written off a pair of lead drug studies after tracking discouraging progression-free survival data in Phase II.