This Day On The Street
Continue to site right-arrow
ADVERTISEMENT
This account is pending registration confirmation. Please click on the link within the confirmation email previously sent you to complete registration.
Need a new registration confirmation email? Click here

Geron: FDA Suspends Key Myelofibrosis Drug Due to Liver Safety Concerns

By: Adam Feuerstein | 03/12/14 - 09:57 AM EDT

Stocks in this article: GERNINCYCTICGILD

Updated from 6:14 am EDT with new information.

Geron
(GERN) received a call from the FDA yesterday which no drug developer ever wants: A full clinical hold has been placed on its lead drug imetelstat due to concerns about liver toxicity.

The FDA-mandated full clinical hold requires Geron to suspend enrollment in all of its imetelstat clinical trials. 

Geron:

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.


It's the Mayo Clinic-sponsored study of Imetelstat in patients with myelofibrosis which had put Geron back on the investor map because of early data suggesting the drug might be capable of reversing the underlying cause of the disease. No word yet on whether FDA has also asked Mayo Clinic to suspect its imetelstat clinical trials, although such a request will not be a surprise now. 

The FDA placed imetelstat on full clinical hold 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," Geron said.

Geron is holding a conference call later this morning. No word yet from the company about how long this clinical hold will last or what will be required to demonstrate to FDA that the drug is safe enough to continue clinical studies. 

Geron shares are down 67% to $1.42 in Wednesday trading. Watch trading in other myelofibrosis-related stocks this morning as well, including Incyte (INCY), Cell Therapeutics (CTIC) and Gilead Sciences (GILD)

I'll leave you with this thought:

Update: On a conference call this morning, Geron said the FDA concerns relate primarily to reports of "persistent" low-grade elevations in liver enzymes reported by almost all imetelstat-treated patients. Regulators want Geron to submit clinical data on the reversibility of these liver toxicity signals.

Dirk Haussecker, a consultant, RNAi expert and blogger, posted this morning on a possible explanation for why imetelstat could be causing liver toxicity. It's worth a read. 


Adam Feuerstein writes regularly for TheStreet. In keeping with company editorial policy, he doesn't own or short individual stocks, although he owns stock in TheStreet. He also doesn't invest in hedge funds or other private investment partnerships. Feuerstein appreciates your feedback; click here to send him an email.

To begin commenting right away, you can log in below using your Disqus, Facebook, Twitter, OpenID or Yahoo login credentials. Alternatively, you can post a comment as a "guest" just by entering an email address. Your use of the commenting tool is subject to multiple terms of service/use and privacy policies - see here for more details.

Markets

DOW 17,813.79 +94.79 0.54%
S&P 500 2,062.08 +9.33 0.45%
NASDAQ 4,713.4420 +11.5750 0.25%

Adam's Tweets

Brokerage Partners

Select the service that is right for you!

COMPARE ALL SERVICES
Action Alerts PLUS

Jim Cramer and Stephanie Link actively manage a real portfolio and reveal their money management tactics while giving advanced notice before every trade.

Product Features:
  • $2.5+ million portfolio
  • Large-cap and dividend focus
  • Intraday trade alerts from Cramer
  • Weekly roundups
Real Money Pro

All of Real Money, plus 15 more of Wall Street's sharpest minds delivering actionable trading ideas, a comprehensive look at the market, and fundamental and technical analysis.

Product Features:
  • Real Money + Doug Kass Plus 15 more Wall Street Pros
  • Intraday commentary & news
  • Ultra-actionable trading ideas
Trifecta Stocks

Trifecta Stocks analyzes over 4,000 equities weekly to find the elite 1% of stocks that pass rigorous quantitative, fundamental and technical tests.

Product Features:
  • Model portfolio
  • Trade alerts
  • Recommendations for over 4,300 stocks
  • Unlimited research reports on your favorite stocks
Stocks Under $10

David Peltier, uncovers low dollar stocks with extraordinary upside potential that are flying under Wall Street's radar.

Product Features:
  • Model portfolio
  • Stocks trading below $10
  • Intraday trade alerts
  • Weekly roundups
Quant Ratings

Access the tool that DOMINATES the Russell 2000 and the S&P 500.

Product Features:
  • Buy, hold, or sell recommendations for over 4,300 stocks
  • Unlimited research reports on your favorite stocks
  • A custom stock screener
  • Upgrade/downgrade alerts
Dividend Stock Advisor

Jim Cramer's protege, David Peltier, identifies the best of breed dividend stocks that will pay a reliable AND significant income stream.

Product Features:
  • Diversified model portfolio of dividend stocks
  • Alerts when market news affect the portfolio
  • Bi-weekly updates with exact steps to take - BUY, HOLD, SELL
Breakout Stocks

Bryan Ashenberg, using sophisticated stock screening and fundamental research, identifies potentially explosive small and mid-cap stocks.

Product Features:
  • Model portfolio
  • Small-cap and mid-cap focus
  • Intraday trade alerts
  • Weekly roundups
Options Profits

Our options trading pros provide daily market commentary and over 100 monthly option trading ideas and strategies to help you become a well-seasoned trader.

Product Features:
  • 100+ monthly options trading ideas
  • Actionable options commentary & news
  • Real-time trading community
  • Options TV
Top Rated Stocks Top Rated Funds Top Rated ETFs