Back to top

Analyst Blog

Zacks Equity Research

Vertex Presents Phase II Data

VRTX

 ZacksTrade Now

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.

Vertex Pharmaceuticals Inc. (VRTX - Snapshot Report) recently announced final data from a phase II study of VX-809 and Kalydeco. The phase II study evaluated adults suffering from cystic fibrosis (CF) and two copies (homozygous) of the most common mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene, F508del.

The study evaluated patients with increasing doses of VX-809 alone for the first 28 days. The next 28 days evaluated the effect of the combination of VX-809 and Kalydeco. The data revealed that patients receiving the combination of VX-809 and Kalydeco showed a significant improvement in lung function compared to placebo from day 28 to 56.

The positive data from the phase II study will encourage Vertex’s plans to begin a pivotal study evaluating the combination of VX-809 (600mg) and Kalydeco (250mg) in homozygous subjects in early 2013.

Very recently, Vertex had announced positive data on Kalydeco from a long-term follow-up study, PERSIST, that was conducted in patients suffering from CF. Vertex plans to initiate three additional pivotal studies this year to evaluate the safety and efficacy of Kalydeco.

A life threatening genetic disease, CF as estimated by Vertex, afflicts approximately 70,000 people worldwide.

We remind investors that Kalydeco was approved in the US, in February 2012, for treating CF patients 6 years and above. Vertex recorded sales of $18.4 million for Kalydeco in the first quarter of 2012.

Vertex is set to gain approval of the drug for the same indication in the European Union (EU), with the European Committee for Medicinal Products for Human Use having given a positive opinion recently.

Our Take

We note that Kalydeco had a strong first quarter and, with the probable EU launch, the drug can be a major growth driver in the future. We expect investor focus to remain on Kalydeco’s EU approval and its performance in the US.

We currently have a Neutral recommendation on Vertex Pharma. 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

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 GROUP DXYN 15.84 +7.90%
BOFL HOLDING 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%