The U.S. Food and Drug Administration (FDA) gave Geron Corp. (NASDAQ: GERN) some good news Monday morning when it removed the clinical hold on the company’s investigational new drug application for imetelstat. Shares of Geron ultimately had an extremely positive reaction. What may be creating an extra bump here is that Geron is one of those long-troubled companies with a very low share price, which trends to attract many of the speculative traders looking to make a quick buck.
The FDA would go on to say that Geron’s proposed clinical development plan for imetelstat, which is focused on high-risk myeloid malignancies such as myelofibrosis, is acceptable. Geron was required by the FDA to provide follow-up information from imetelstat-treated patients who experienced liver function test abnormalities until such abnormalities were resolved to normal or baseline.
If this news and move feel familiar at all, it feel like a “return to normalcy” we covered back in March. Geron initially responded to the clinical hold in March:
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.
The company submitted data to the FDA which concluded that the essential thrombocythemia (ET) trial LFT abnormalities were resolved to normal or baseline in 14 of 18 follow-up patients. For the remaining four ET patients, at the time of the data cut-off, three patients showed improvement in LFT abnormalities and one patient had unresolved LFT abnormalities.
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The hold was originally 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.
This news acts only to remind why Needham raised its rating up to Buy with a $10 price target just over a year ago.
Shares of Geron were trading up over 30% at $2.93 shortly after noon on Monday. The real issue that stands out is the 19.8 million shares already seen midday, because an average day’s volume is merely 2 million shares. The consensus analyst price target is $4.13, and the 52-week trading range is $1.31 to $7.36.
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