GERN -2.87 to 1.53, really getting whacked. Company has roughly $1 per share cash, but isn't this likely the "death knell" for Imetelstat ? Wouldn't it seem that the probabilities of resuming clinical trials are small ?
Menlo Park, Calif., March 12, 2014 - Geron Corporation (Nasdaq: GERN)
announced today that the company has received verbal notice from the
U.S. Food and Drug Administration (FDA) that its Investigational New
Drug (IND) application for imetelstat has been placed on full clinical
hold, affecting all ongoing company-sponsored clinical trials. 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 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 has not yet received written notice of its clinical hold from the
FDA, but based on the verbal communication yesterday afternoon, the FDA
indicated that the clinical hold is due to the occurrence of persistent
low-grade liver function test (LFT) abnormalities observed in the Phase
2 study of imetelstat in ET/PV patients and the potential risk of
chronic liver injury following long-term exposure to imetelstat. The FDA
expressed concern about whether these LFT abnormalities are reversible.
Geron plans to work diligently with the FDA to seek the release of the
clinical hold.
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