Back to top

Analyst Blog

GTx, Inc. (GTXI - Snapshot Report) suffered a setback recently with its phase III candidate, enobosarm, failing to meet overall requirements for the co-primary responder endpoints of lean body mass and physical function as agreed upon with the U.S. Food and Drug Administration (FDA). Results were presented from the placebo controlled, double blind POWER studies that were conducted in patients receiving chemotherapy for non-small cell lung cancer (NSCLC).

The studies were evaluating the use of enobosarm for the prevention and treatment of muscle wasting in patients with non-small cell lung cancer.

As far as the pre-specified continuous variable analysis discussed with the European regulators using the same endpoints were concerned, GTx said that enobosarm demonstrated a consistently positive effect on lean body mass relative to placebo in both studies. Enobosarm was well tolerated with the occurrence of serious adverse events and the overall occurrence of adverse events being similar to placebo.

Although the company expressed disappointment in enobosarm’s failure to meet the pre-specified responders analyses criteria in both studies, GTx said that it intends to discuss the future development path for enobosarm with the regulatory authorities given the consistent positive effects on muscle, the tolerability profile and the association of lean body mass with a survival signal.

Our Take

The phase III results are a major setback for GTx – shares were down more than 60% on the news. Although the company is looking to discuss the future path with the U.S. and the EU regulatory authorities, we expect investor focus to shift to Capesaris, which is in phase II development as a secondary hormonal therapy in men with metastatic castration resistant prostate cancer.

GTx currently carries a Zacks Rank #3 (Hold). At present, companies like Actelion Ltd. (ALIOF), Biogen Idec (BIIB - Analyst Report) and Gilead Sciences, Inc. (GILD - Analyst Report) look well-positioned with all three being Zacks Rank #1 (Strong Buy) stocks.

Please login to or register to post a comment.

New to Zacks?

Start Here

Zacks Investment Research


Are you a new Zacks Member or a visitor to

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 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
ERBA DIAGNO… ERB 3.80 +7.04%
BANCO DO BR… BDORY 14.74 +5.66%
AIR INDUSTR… AIRI 9.99 +4.15%
EQT MIDSTRE… EQM 98.14 +3.38%
WEATHERFORD… WFT 23.64 +3.10%