Back to top

Analyst Blog

Idenix Pharmaceuticals, Inc. (IDIX - Snapshot Report) recently suffered a huge setback when it received a verbal notice from the US Food and Drug Administration (FDA) placing a partial clinical hold on its hepatitis C candidate, IDX184. IDX184, a nucleotide polymerase inhibitor, is being evaluated as a treatment for hepatitis C virus (HCV). Idenix shares were down significantly on the news.

The FDA has asked Idenix to conduct additional cardiac tests on patients in the ongoing phase IIb study of IDX184 in combination with pegylated-interferon and ribavirin for the treatment of HCV.

In June 2012, Idenix had reported positive interim data from the study. The data demonstrated that patients on IDX184 combination therapy achieved 100% and 80% sustained virologic response (SVR) with 100 mg and 50 mg dose, respectively.

In July 2012, the safety data of the trial was reviewed by an independent data safety monitoring board and found to be consistent with that of pegylated-interferon and ribavirin alone. Idenix planned the initiation of another study on IDX184 by the end of 2012, which might get delayed due to the FDA’s action.

The FDA placed a partial clinical hold on IDX184 to review its safety after serious cardiac-related adverse events were found to be associated with  Bristol-Myers Squibb Company’s (BMY - Analyst Report) BMS-986094 (formerly known as INX-189). BMS-986094 is also a nucleotide polymerase inhibitor being developed for the treatment of HCV.

We remind investors that BMS-986094 was added to Bristol-Myers’ pipeline following its acquisition of Inhibitex Inc. earlier this year. On a conference call to address the issue, Idenix noted that the two drugs, IDX184 and BMS-986094, are significantly different.

Our Recommendation

We currently have a Neutral recommendation on Idenix. The stock carries a Zacks #3 Rank (Hold rating) in the short run.

Please login to Zacks.com or register to post a comment.

New to Zacks?

Start Here

Zacks Investment Research

Close

Are you a new Zacks Member or a visitor to Zacks.com?

Top Zacks Features

My Portfolio Tracker

Is it Time to Sell?

One of the most important steps you can take today is to set up your portfolio tracker on Zacks.com. Once you do, you'll be notified of major events affecting your stocks and/or funds with daily email alerts.

More Zacks Resources

Zacks Rank Home - Evaluate your stocks and use the Zacks Rank to eliminate the losers and keep the winners.

Mutual Fund Rank Home - Evaluate your funds with the Mutual Fund Rank for both your personal and retirement funds.

Stock/Mutual Fund Screening - Find better stocks and mutual funds. The ones most likely to beat the market and provide a positive return.

My Portfolio - Track your Portfolio and find out where your stocks/mutual funds stack up with the Zacks Rank.

Zacks #1 Rank Top Movers for Zacks #1 Rank Top Movers

Company Symbol Price %Chg
RPC INC RES 24.91 +8.35%
LITHIA MOTO… LAD 94.59 +4.60%
DELTA AIR L… DAL 39.15 +3.90%
FLAMEL TECH… FLML 14.51 +3.50%
SOUTHWEST A… LUV 28.87 +2.92%