USA-based Geron Corp (Nasdaq: GERN) saw its shares plunge 59% to $1.79 when the company revealed that it had received verbal notice from the US Food and Drug Administration that its Investigational New Drug application for imetelstat has been placed on full clinical hold, affecting all ongoing company-sponsored clinical trials.
The clinical hold affects the remaining eight patients in the company's Phase II study in essential thrombocythemia (ET) or polycythemia vera (PV) and the remaining two patients in the company's Phase II study in multiple myeloma. In addition, the company's planned Phase II 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.
Nothing else in the Geron pipeline
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