Join        Login             Stock Quote

Why United Therapeutics (UTHR) Shares Tumbled?

 October 24, 2012 02:57 PM

(By Balachander) United Therapeutics Corp. (NASDAQ: UTHR) shares tumbled over 15 percent on Wednesday after after the U.S. Food and Drug Administration (FDA) declined to approve its new drug application (NDA) for oral treprostinil as a treatment for pulmonary arterial hypertension (PAH). 

In its letter, the FDA questioned the clinical importance of the six- minute walk distance (6MWD) improvement of 23 meters in FREEDOM-M, the inability to confirm the 6MWD benefit in the two FREEDOM-C studies and the inability to demonstrate improvement in time to clinical worsening in all phase 3 trials.

In a conference call, the company indicated that it would persevere toward gaining oral treprostinil approval with recent initiation of the FREEDOM-EV study but that timelines for data were likely extended to 2H16.

[Related -Super-Fast Growing Mid-Cap Growth Stocks With Explosive Returns]

BMO Capital Markets downgraded its rating on UTHR to "Market Perform" from "Outperform" and reducing its price target to $50.

Given the uncertainty of oral treprostinil approvability and extended timelines for clinical worsening data from FREEDOM-EV, we have removed the product's contribution from our financial estimates," the brokerage said.

"While Remodulin IV and Tyvaso formulations of treprostinil continue to show modest growth, the emergence of newer oral agents macitentan and riociguat could delay the time to prostacyclin therapy," BMO wrote.

"Finally, with oral tresprostinil as a key offset to potential generic Remodulin risk in late 2014 we believe that risk to estimates has increased following the FDA CRL," the brokerage said. "At current levels we advise a wait-and-see approach to existing product trends and timelines for FREEDOM-EV completion before recommending UTHR shares."

[Related -Pharma Favorites With Buybacks]

Shares plunged 13.80 percent to trade at $45.92 on Wednesday. In the past 52-weeks, the stock has been trading between $38.93 and $59.00.



Post Comment -- Login is required to post message
Alert for new comments:
Your email:
Your Website:

rss feed

Latest Stories

article imageTackling China's Debt Problem: Can Debt-Equity Conversions Help?

China’s high and rising corporate debt problem and how best to address it has received much attention read on...

article imageWill Job Growth Kill The Bear-Market Signal For Stocks?

It’s all about jobs now. Actually, it’s always been about jobs. But the stakes are even higher—perhaps more read on...

article imageAutomating Ourselves To Unemployment

In this current era of central planning, malincentives abound. We raced to frack as fast we could for the read on...

article imageFed: Waiting For June… Or Godot?

The Federal Reserve left interest rates unchanged yesterday, as widely expected. But the possibility of a read on...

Popular Articles

Daily Sector Scan
Partner Center

Fundamental data is provided by Zacks Investment Research, and Commentary, news and Press Releases provided by YellowBrix and Quotemedia.
All information provided "as is" for informational purposes only, not intended for trading purposes or advice. iStockAnalyst.com is not an investment adviser and does not provide, endorse or review any information or data contained herein.
The blog articles are opinions by respective blogger. By using this site you are agreeing to terms and conditions posted on respective bloggers' website.
The postings/comments on the site may or may not be from reliable sources. Neither iStockAnalyst nor any of its independent providers is liable for any informational errors, incompleteness, or delays, or for any actions taken in reliance on information contained herein. You are solely responsible for the investment decisions made by you and the consequences resulting therefrom. By accessing the iStockAnalyst.com site, you agree not to redistribute the information found therein.
The sector scan is based on 15-30 minutes delayed data. The Pattern scan is based on EOD data.