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United Therapeutics Scores FDA Nod For New Tyvaso Review
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United Therapeutics Scores FDA Nod For New Tyvaso Review

United Therapeutics (UTHR) has announced that the U.S. Food and Drug Administration (FDA) has accepted for review the supplemental New Drug Application (sNDA) for Tyvaso (treprostinil) Inhalation Solution for the treatment of pulmonary hypertension associated with interstitial lung disease (PH-ILD).

United Therapeutics expects the agency’s review to be complete in April 2021. 

“Tyvaso, if approved by the FDA, would be the first and only therapeutic approved for the treatment of PH-ILD, a condition that afflicts approximately 30,000 people in the United States,” said Martine Rothblatt, CEO of United Therapeutics.

“We look forward to working with the Agency during the regulatory review process, with the goal of expanding the population of patients with pulmonary hypertension who could benefit from this important medicine.”

The sNDA is based on data from the phase 3 INCREASE clinical study of Tyvaso, a prostacyclin vasodilator, in 326 adult patients suffering from World Health Organization (WHO) Group 3 PH-ILD.

The INCREASE study met its primary endpoint as Tyvaso increased six-minute walk distance by 21 meters versus placebo after 16 weeks of treatment. Benefits of Tyvaso were also observed across several key subgroups, including etiology of PH-ILD, disease severity, age, gender, dose, and baseline hemodynamics.

Significant improvements were also observed in each of the study’s secondary endpoints, including reduction in the cardiac biomarker and time to first clinical worsening event.

Treatment with Tyvaso of up to 12 breaths per session, four times daily, in the INCREASE study was well tolerated. The safety profile was consistent with previous Tyvaso studies in pulmonary arterial hypertension and known prostacyclin-related adverse events.

Interstitial lung disease (ILD) is a group of lung diseases that are characterized by significant scarring or fibrosis of the bronchioles and alveolar sacs within the lungs. Pulmonary hypertension often complicates the course of ILD patients and is associated with worse functional status, greater oxygen needs, decreased quality of life, and worse outcomes.

The FDA approved Tyvaso in July 2009 for pulmonary arterial hypertension.

So far year-to-date the stock has surged 24% and analysts have a bullish Strong Buy consensus on UTHR’s outlook. That’s with an average analyst price target of $157, indicating a further 43% upside potential from current levels.

Wedbush analyst Liana Moussatos has just reiterated her buy rating on UTHR with a $244 price target- suggesting the stock can more than double from current levels. She made the call after the company reported better-than-expected Q2 net revenue of $362.0M, easily beating the consensus of $341.0M.

“We see increased market opportunity from Tyvaso indication expansion into PH-ILD (following positive INCREASE data at ATS) as well as product indications expansion for existing treprostinil-based products” the analyst commented. (See UTHR stock analysis on TipRanks).

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