Back to top

Analyst Blog

This page is temporarily not available.  Please check later as it should be available shortly. If you have any questions, please email customer support at support@zacks.com or call 800-767-3771 ext.  9339.

Pluristem Therapeutics Inc. (PSTI - Snapshot Report) recently announced that it has provided the US Food and Drug Administration (FDA) with additional information regarding the clinical trials for intermittent claudication (IC) pursuant to a clinical hold on the phase II IC study earlier this month.

We remind investors that on Jun 4, 2013, the company was informed that the FDA has placed a clinical hold on a phase II IC study following a serious allergic reaction in one of the patients who required subsequent hospitalization. The patient was discharged the next day after the symptoms were managed.

Pluristem pointed out that the patient was suffering from multiple diseases which might have affected the severity of the allergic reaction.

Although the 30-day period within which the FDA is expected to provide a letter to the company containing a list of questions and information required is yet to expire, Pluristem has already provided the agency with additional information so as to speed up the review and resolution of the issues. The company provided information from a database compiled from previous clinical studies.

Meanwhile, as the study is being conducted both in the US and Germany, Pluristem informed the Paul-Ehrlich-Institute (PEI) in Germany about the clinical hold by the FDA and provided relevant information.  Consequently, the IC study in Germany has also been put on hold.

Pluristem develops placenta-based cell therapies and currently does not have any approved product/therapy. Hence, a hold on the mid-stage trial in the US and Germany is a major setback for the company.

We expect investor focus in the near term to remain on further updates on the clinical hold.

Celgene Cellular Therapeutics, a wholly-owned subsidiary of Celgene Corporation (CELG - Analyst Report), is also conducting research on stem cells derived from the human placenta as well as from the umbilical cord for the treatment of different diseases.

Pluristem carries a Zacks Rank #4 (Sell). Right now, Biogen Idec, Inc. (BIIB - Analyst Report) and Aeterna Zentaris, Inc. look attractive. While Biogen Idec carries a Zacks Rank #1 (Strong Buy), Aeterna  Zentaris carries a Zacks Rank #2 (Buy).

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

Learn more

Start for as little as $4.50 per trade.

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
DIXIE GRP IN DXYN 15.84 +7.90%
BOFI HLDG IN BOFI 85.30 +4.97%
RAMBUS INC RMBS 12.31 +4.41%
VIPSHOP HOLD VIPS 148.73 +4.35%
NETFLIX INC NFLX 345.74 +4.32%