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United Therapeutics Discontinues PAH Drug After Study Fails

Zacks Equity Research

Shares of United Therapeutics Corporation UTHR plunged almost 6% after the company announced that a phase III BEAT study did not meet its primary endpoint. The study was evaluating pipeline candidate esuberaprost in combination with marketed PAH drug Tyvaso as Tysuberprost in patients with PAH, who showed signs of deterioration on Tyvaso or had a less than optimal response to Tyvaso treatment. The primary endpoint of delayed time to first clinical worsening event was not successfully met in the study. However, share price of the company have increased 4.6% in the past year compared with the industry’s growth of 16.9%.

As a result, United Therapeutics decided to discontinue further development of esuberaprost.

The company holds a strong position in the PAH market, with four approved products targeting this indication. The company’s lead product is Remodulin, which is an injectable formulation of treprostinil, and available for both subcutaneous (SC) and intravenous (IV) use. Other products in the portfolio are Orenitram, an oral version of treprostinil; Tyvaso, an inhaled version of treprostinil; and Adcirca tablet (tadalafil), which is also sold by Eli Lilly LLY as Cialis to treat erectile dysfunction.

United Therapeutics is working to expand labels for some of its marketed products like Orenitram and Tyvaso. A phase III FREEDOM-EV study evaluated an oral combination therapy of Orenitram — OreniPlus. In August 2018, the company announced preliminary data from the study. The study met the primary endpoint, showing that Orenitram in combination with an oral PAH background therapy delayed disease progression. United Therapeutics has submitted regulatory application in the United States to get FREEDOM-EV data included in the label of Orenitram.

Other important late-stage studies include Tyvaso-ILD (where Tyvaso is being evaluated in patients with PAH associated with idiopathic pulmonary fibrosis), OreniLeft (Orenitram is being evlauted to treat PAH with left ventricular diastolic dysfunction), gene therapy Aurora-GT for PAH and inhaled treprostinil in PAH patients, who have COPD. Success in these studies may open up attractive market opportunities and address significant unmet clinical needs.


United Therapeutics Corporation Price


United Therapeutics Corporation Price | United Therapeutics Corporation Quote

Zacks Rank & Stocks to Consider

United Therapeutics currently carries a Zacks Rank #3 (Hold). 

Some better-ranked stocks from the same space are Eisai Co. ESALY and BioSpecifics Technologies Corp. BSTC, each carrying a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

Eisai’s earnings per share estimates have increased from $1.86 to $1.95 and from $1.89 to $2.02 for 2019 and 2020, respectively, in the past 60 days.

BioSpecifics Technologies’ earnings per share estimates have increased from $2.78 to $3.01 for 2019 over the past 60 days. The company delivered a positive earnings surprise in two of the trailing four quarters at an average of 12.46%.

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