Geron Plunges on FDA Clinical Hold - Analyst Blog


Geron Corporation's ( GERN ) shares plunged 61.6% on news that the FDA has placed a full clinical hold on the company's only pipeline candidate, imetelstat.

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.

Studies Affected

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 hold.

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.

Our Take

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. ( GILD ), Alkermes plc ( ALKS ) and Alexion Pharmaceuticals, Inc. ( ALXN ) with all three being Zacks Rank #1 (Strong Buy) stocks.

ALKERMES INC (ALKS): Free Stock Analysis Report

ALEXION PHARMA (ALXN): Free Stock Analysis Report

GERON CORP (GERN): Free Stock Analysis Report

GILEAD SCIENCES (GILD): Free Stock Analysis Report

To read this article on click here.

Zacks Investment Research

The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of The NASDAQ OMX Group, Inc.

This article appears in: Investing , Business , Stocks

Referenced Stocks: IND , ALKS , ALXN , GERN , GILD

More from

Related Videos



Most Active by Volume

  • $16.955 ▲ 1.71%
  • $5.415 ▲ 4.94%
  • $10.32 ▲ 1.88%
  • $35.05 ▲ 2.01%
  • $8.89 ▼ 0.34%
  • $32.67 ▼ 1.80%
  • $13.61 ▼ 3.13%
  • $130.11 ▲ 0.12%
As of 6/3/2015, 02:54 PM

Find a Credit Card

Select a credit card product by:
Select an offer:
Data Provided by