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 ($GERN) by 35% in premarket trading.
The Menlo Park, CA-based biotech also has received a green light from the FDA for its clinical trial design for high-risk myeloid malignancies like myelofibrosis, a rare bone marrow cancer. And the agency signed off on Geron's decision to drop plans to test the drug for essential thrombocythemia or polycythemia vera.
Geron was essentially derailed by the FDA's hold in the spring, watching its stock plunge 60% on the news. The turbulence followed the decision at Geron to jettison another experimental drug for brain cancer back in 2012 after a clinical trial failure. That setback forced deep budget cuts and layoffs. And its 20 year-plus odyssey in the clinic has also been marked by the decision to get rid of its stem cell programs back in 2011.
To get back on track with imetelstat Geron had to provide followup liver tox results for 18 patients as well as new animal research outcomes.
Now Geron says it's ready to launch a Phase II study of imetelstat for myelofibrosis in the first half of 2015. The company also spelled out its latest quarterly results today. The net loss on the first 9 months now stands at $26.7 million.
- here's the release