Key Developments For United Therapeutics Corporation
United Therapeutics Corporation (UTHR.O) (Nasdaq)
United Therapeutics Corporation Announces Stock Split To Be Effected as Stock Dividend
United Therapeutics Corporation announced that its Board of Directors has approved and declared a stock split. The stock split will be effected in the form of a stock dividend, in which one share of United Therapeutics common stock will be distributed for each share of common stock issued and outstanding (or held in treasury) at the close of business on the record date, September 14, 2009. The additional shares of common stock are scheduled to be distributed on September 22, 2009, to all shareholders of record by BNY Mellon, United Therapeutics' transfer agent.
FDA Approves United Therapeutics Corporation's TYVASO (treprostinil) Inhalation Solution
United Therapeutics Corporation announced that the United States Food and Drug Administration (FDA) has approved TYVASO (treprostinil) Inhalation Solution for the treatment of pulmonary arterial hypertension (PAH) using the TYVASO Inhalation System (which includes the Optineb-ir device and accessories). TYVASO is indicated to increase walk distance in patients with NYHA Class III symptoms associated with WHO Group I PAH, which includes multiple etiologies such as idiopathic and familial PAH as well as PAH associated with scleroderma and congenital heart disease. In connection with the TYVASO approval, United Therapeutics has agreed to Post-Marketing Commitments (PMC) to modify certain aspects of the TYVASO Inhalation System, perform a usability analysis and collect pharmacokinetic data to verify expected dosing with the modified device. Additionally, United Therapeutics has agreed to a Post-Marketing Requirement (PMR) to conduct a long-term observational study to evaluate the risk of oropharyngeal and pulmonary toxicities among patients using TYVASO.
United Therapeutics Corporation And Eli Lilly And Company Announces Findings from the PHIRST-1 Study Of Patients With Pulmonary Arterial Hypertension
United Therapeutics Corporation and Eli Lilly and Company announced the results of a pivotal 16 week study showing that a once daily dose of tadalafil was generally well tolerated, improved exercise capacity and improved time to clinical worsening in patients with pulmonary arterial hypertension (PAH)(1). The randomized, double blind, 16 week, placebo controlled Phase III study followed 405 patients with PAH, either treatment naive or taking bosentan, randomized to placebo or tadalafil 2.5 mg, 10 mg, 20 mg or 40 mg orally. The study formed the basis of the United States Food and Drug Administration (FDA) approval to market tadalafil tablets for the treatment of PAH under the brand name ADCIRCA.
FDA Approves United Therapeutics Corporation's ADCIRCA (Tadalafil) Tablets For Treatment Of Pulmonary Arterial Hypertension
United Therapeutics Corporation announced that the United States Food and Drug Administration (FDA) has approved ADCIRCA (tadalafil) tablets for oral administration, with a recommended dose of 40 mg, as the first once-daily phosphodiesterase type 5 (PDE5) inhibitor for the treatment of pulmonary arterial hypertension (PAH). In the PHIRST-1 randomized, double-blind, 16-week placebo-controlled Phase 3 clinical trial of ADCIRCA for PAH, patients taking ADCIRCA 40 mg (administered as two 20 mg tablets) once daily achieved a 33 meter improvement in six-minute walk distance compared to the placebo group. In addition, PHIRST-1 patients taking ADCIRCA 40 mg experienced less clinical worsening (defined as death, lung transplantation, atrial septostomy, hospitalization because of worsening PAH, initiation of new PAH therapy, or worsening WHO functional class) compared to the placebo group.
U.S. Food and Drug Administration Extends Action Date For United Therapeutics Corporation's Inhaled Treprostinil (Tyvaso) New Drug Application By Three Months
United Therapeutics Corporation announced that the U.S. Food and Drug Administration (FDA) will require additional time to complete its review of the New Drug Application (NDA) for Tyvaso (inhaled treprostinil). In a notice received, the FDA extended the Prescription Drug User Fee Act (PDUFA) date from April 30, 2009, to July 30, 2009.
