) shares plunged 61.6% on news that the FDA has placed a full
clinical hold on the company's only pipeline candidate,
What is a Clinical Hold?
A clinical hold is an order issued by the FDA under which the
sponsor of the study is asked to delay a proposed trial or
suspend an ongoing trial. Geron had submitted an Investigational
New Drug (IND) application for imetelstat to the FDA. However,
the FDA issued a verbal notice placing the company's IND
application for imetelstat on hold. So, not only will the company
not be able to initiate a study on imetelstat, the notice will
also affect currently ongoing studies on imetelstat which have
been sponsored by Geron.
Currently ongoing studies include a phase II study in
essential thrombocythemia (ET) or polycythemia vera (PV) and
another phase II study in multiple myeloma. Moreover, Geron's
plans of conducting a phase II study in myelofibrosis, scheduled
to commence in the first half of this year, will most likely get
delayed due to the clinical hold. Chances remain that
investigator-sponsored studies will also be placed on clinical
Cause for Concern
Although Geron is yet to receive a written notice regarding
the clinical hold, the company said that the FDA is concerned
about the occurrence of persistent low-grade liver function test
(LFT) abnormalities in the phase II study for ET/PV as well as
the potential risk of chronic liver injury following long-term
exposure to imetelstat. The agency is concerned about the
possibility of reversing these LFT abnormalities.
The full clinical hold on imetelstat is a major setback for
Geron. Geron has suffered imetelstat-related setbacks earlier too
- the company had to drop its plans to develop the candidate for
breast cancer and non-small cell lung cancer. With the FDA
voicing concerns about safety, we currently have low visibility
on when imetelstat-based studies can resume/commence.
Even if imetelstat studies continue, concerns about LFT
abnormalities could limit the commercial potential of the
candidate and restrict its long-term usage.
Geron is a Zacks Rank #4 (Sell) stock. Better-ranked stocks in
the biotech sector include
Gilead Sciences Inc.
Alexion Pharmaceuticals, Inc.
) with all three being Zacks Rank #1 (Strong Buy) stocks.
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