Back to top

Analyst Blog

United Therapeutics Corporation (UTHR - Analyst Report) recently announced that the US Food and Drug Administration (FDA) has accepted its new drug application (NDA) for oral Remodulin (treprostinil) that was re-submitted by the company following the receipt of a complete response letter (CRL) from the FDA in Oct 2012. United Therapeutics is looking to get oral Remodulin approved for the treatment of pulmonary arterial hypertension.

The FDA is treating the resubmitted NDA as a complete, class 1 response and will respond to the application by Mar 31, 2013.

We note that United Therapeutics is facing a patent challenge for Remodulin (treprostinil) injection. Sandoz is seeking approval for its generic version of Remodulin (10 mg/mL). United Therapeutics has filed a patent infringement lawsuit against Sandoz. Remodulin, the key revenue generator at United Therapeutics, accounts for almost 50% of sales.

United Therapeutics currently carries a Zacks Rank #1 (Strong Buy). The company is well-positioned to gain share in the pulmonary arterial hypertension market. Remodulin continues to look very strong in both the intravenous (IV) and subcutaneous (SC) forms.

With the approval of Adcirca and Tyvaso, United Therapeutics has a varied range of therapies available for the treatment of pulmonary arterial hypertension. We believe the company’s pulmonary arterial hypertension product portfolio will drive strong top-and bottom-line growth.

Other players in the pulmonary arterial hypertension market include companies like Gilead (GILD - Analyst Report) and Pfizer (PFE - Analyst Report) among others. We believe competition will continue to increase with several companies working on bringing additional therapies to the market.

Another company that currently looks well-positioned is Valeant Pharmaceuticals (VRX - Snapshot Report). Valeant is also a Zacks Rank #1 stock.
 

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
SYNAPTICS I… SYNA 78.11 +8.14%
GREEN PLAIN… GPRE 39.41 +5.12%
PILGRIM'S P… PPC 28.82 +3.08%
SKYWORKS SO… SWKS 52.07 +2.58%
CLAYTON WIL… CWEI 109.08 +2.51%