Wednesday’s drop is by more than half after the company issued a press release saying that it has received verbal notice from the U.S. Food and Drug Administration (FDA) has placed a full clinical hold on Geron’s Investigational New Drug application for imetelstat.
The hold was said to be due to the occurrence of persistent low-grade liver function test abnormalities observed in the Phase 2 study of imetelstat in ET/PV patients, as well as the potential risk of chronic liver injury following long-term exposure to imetelstat.
A full clinical hold is an order that the FDA issues to a trial sponsor to suspend an ongoing clinical trial or delay a proposed trial. The hold impacts all ongoing company-sponsored clinical trials.
Geron said:
The clinical hold affects the remaining eight patients in the company’s Phase 2 study in essential thrombocythemia (ET) or polycythemia vera (PV) and the remaining two patients in the company`s Phase 2 study in multiple myeloma. In addition, the company`s planned Phase 2 clinical trial in myelofibrosis will likely be delayed due to the clinical hold. It is possible that other studies using imetelstat, such as ongoing investigator-sponsored trials, may also be placed on clinical hold by the FDA.
Geron’s market cap prior to this news was $567 million, but shares are indicated sharply lower — some 61% — at $1.72 after closing at $4.40 on Tuesday. Geron’s 52-week trading range is $0.98 to $7.79.
Geron trades an average of about 4.6 million shares per day. It seems safe to assume that this share volume will be far higher on Wednesday.
Top Gaining Stocks
Top Losing Stocks