Key Developments: United Therapeutics Corp (UTHR.O)
69.17USD
17 May 2013
$0.69 (+1.01%)
$68.48
$68.63
$69.21
$67.71
515,066
836,750
$69.21
$41.55
Latest Key Developments (Source: Significant Developments)
United Therapeutics Corp Reaffirms FY 2013 Revenue Guidance
United Therapeutics Corp reaffirmed fiscal 2013 revenue guidance and continue to expect revenues to fall within a range of 5% above or below $1 billion. Full Article
United Therapeutics Corp Reaffirms FY 2013 Revenue Guidance
United Therapeutics Corp reaffirmed fiscal 2013 revenue guidance and continue to expect revenues to fall within a range of 5% above or below $1 billion. Full Article
United Therapeutics Corp Announces FDA Acceptance For Resubmission Of Oral Treprostinil NDA
United Therapeutics Corp announced that the U.S. Food and Drug Administration (FDA) has acknowledged the resubmission of the new drug application (NDA) for treprostinil diolamine extended release tablets (oral treprostinil) for the treatment of pulmonary arterial hypertension. The FDA classified the resubmission as a complete, class 1 response to FDA's October 23, 2012 complete response letter and the FDA set a user fee goal date of March 31, 2013. Full Article
United Therapeutics Corp Announces Additional $420 Million Share Repurchase Program
United Therapeutics Corp announced that its Board of Directors has authorized the repurchase of up to an additional $420 million of the Company's common stock. This program will become effective on March 4, 2013, and will remain open for up to one year. The company also announced that it had recently completed its previously-announced $100 million repurchase program by purchasing approximately 1,186,000 shares of common stock for a total of $57.1 million during the fourth quarter of 2012. Full Article
United Therapeutics Corp Reaffirms FY 2012 Revenue Guidance
United Therapeutics Corp reaffirmed its fiscal 2012 revenue guidance for its three commercial products (Remodulin, Tyvaso and Adcirca), as the Company continue to expect related revenues to fall within a range of 5% above or below $875 million for fiscal 2012. Full Article
United Therapeutics Corporation Reaffirms FY 2012 Revenue Guidance
United Therapeutics Corporation reaffirmed fiscal 2012 guidance and expects related revenues to fall within a range of 5% above or below $875 million. According to I/B/E/S Estimates, analysts are expecting the Company to report revenue of $866 million for fiscal 2012. Full Article
United Therapeutics Corporation Reaffirms FY 2012 And FY 2013 Revenue Guidance-Conference Call
United Therapeutics Corporation reaffirmed fiscal 2012 and fiscal 2013 guidance and expects revenues to fall within a range of 5% above or below $875 million for fiscal 2012 and $1 billion for fiscal 2013. According to I/B/E/S Estimates, analysts on an average are expecting the Company to report revenue of $867 million for fiscal 2012. Full Article
United Therapeutics Corporation Files Lawsuit Against Sandoz Inc For Infringement Of Remodulin Patents
United Therapeutics Corporation announced that it has filed a lawsuit in the U.S. District Court for the District of New Jersey against Sandoz Inc. (Sandoz) for infringement of U.S. Patent Nos. 5,153,222, 6,765,117 and 7,999,007 relating to United Therapeutics' product Remodulin(treprostinil) injection (Remodulin). The lawsuit is based on an Abbreviated New Drug Application (ANDA) filed by Sandoz with the U.S. Food and Drug Administration (FDA) requesting approval to market a generic version of the 10 mg/mL strength of Remodulin. Sandoz's ANDA alleges that the three patents mentioned above are not valid, not enforceable and/or will not be infringed by the commercial manufacture, use or sale of the proposed product described in Sandoz's ANDA submission. United Therapeutics filed its lawsuit within 45 days of receipt of notice from Sandoz of its ANDA filing. As a result, under the Hatch-Waxman Act, the FDA is automatically precluded from approving Sandoz's ANDA for up to 30 months. Full Article
United Therapeutics Corporation Announces New Drug Application Accepted By FDA For Review
United Therapeutics Corporation announced that the U.S. Food and Drug Administration has accepted for review the new drug application (NDA) for treprostinil diethanolamine sustained release tablets (oral treprostinil) for the treatment of pulmonary arterial hypertension. The NDA will be subjected to a standard 10-month review period, with a targeted user fee deadline of October 27, 2012. Full Article
United Therapeutics Corporation Reaffirms FY 2012 And Reaffirms FY 2013 Revenue Guidance
United Therapeutics Corporation reaffirmed fiscal 2012 and fiscal 2013 guidance and expects revenues to fall within a range of 5% above or below $875 million for fiscal 2012 and $1 billion for fiscal 2013. According to I/B/E/S Estimates, analysts on an average are expecting the Company to report revenue of $880 million for fiscal 2012. Full Article
FDA rejects United Therapeutics' oral hypertension drug again
- Biotechnology company United Therapeutics Corp said the oral version of its drug to treat hypertension was rejected for the second time by health regulators, sending its shares down as much as 7 percent in morning trade on the Nasdaq.
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