Please ensure Javascript is enabled for purposes of website accessibility

This One's a Winner

By Charly Travers – Updated Nov 16, 2016 at 1:47PM

You’re reading a free article with opinions that may differ from The Motley Fool’s Premium Investing Services. Become a Motley Fool member today to get instant access to our top analyst recommendations, in-depth research, investing resources, and more. Learn More

Encysive awaits FDA approval, and all signs are positive.

We biotech investors are generally an incredibly patient group, often waiting out the lengthy clinical trials required to get drugs approved by the FDA. But even though we're used to waiting years for these stories to play out, it's nice to find biotechs with near-term catalysts that could increase the value of the company in a much shorter period of time.

Encysive Pharmaceuticals (NASDAQ:ENCY) is on the clock right now. It has filed for approval of its pulmonary arterial hypertension drug, Thelin, in both the U.S. and Europe and it should get the green light to start selling the drug next year. Sometimes it can be hard to predict whether or not a drug is going to get approved, but that is not the case here. This is about as close to a slam-dunk approval as you can get.

While it's usually not a good idea to make too aggressive a prediction of what the FDA will do, there's a lot of evidence to support this position. Thelin has a very compelling clinical-data package. In a phase 3 trial, Thelin was compared head-to-head with the market leader, Actelion's Tracleer, and the results were very favorable. Thelin had a modest edge in efficacy, but clearly came out on top in the safety profile with a much lower incidence of liver-function abnormality.

Tracleer is currently a $400 million-a-year drug and Actelion's management expects it to become a $750 million product. I think Thelin is going to take away a big chunk of these sales because it's simply a better drug. Even with Pfizer's (NYSE:PFE) Revatio recently entering the market, I see Thelin as a clear winner in this space with sales potential of several hundred million dollars a year.

Encysive's stock has doubled in the last year, but I think it's got a lot of room left to run. For continuing coverage of Encysive and other companies in the biotech universe, take a risk-free trial to Motley Fool Rule Breakers.

For more on the biotech industry, see:

Pfizer is a Motley Fool Inside Value pick.

Charly Travers does not own shares of any company mentioned in this article. The Motley Fool has an ironclad disclosure policy.

None

Invest Smarter with The Motley Fool

Join Over 1 Million Premium Members Receiving…

  • New Stock Picks Each Month
  • Detailed Analysis of Companies
  • Model Portfolios
  • Live Streaming During Market Hours
  • And Much More
Get Started Now

Stocks Mentioned

Pfizer Inc. Stock Quote
Pfizer Inc.
PFE
$44.08 (-1.10%) $0.49

*Average returns of all recommendations since inception. Cost basis and return based on previous market day close.

Related Articles

Motley Fool Returns

Motley Fool Stock Advisor

Market-beating stocks from our award-winning analyst team.

Stock Advisor Returns
339%
 
S&P 500 Returns
109%

Calculated by average return of all stock recommendations since inception of the Stock Advisor service in February of 2002. Returns as of 09/24/2022.

Discounted offers are only available to new members. Stock Advisor list price is $199 per year.

Premium Investing Services

Invest better with The Motley Fool. Get stock recommendations, portfolio guidance, and more from The Motley Fool's premium services.