United Therapeutics Corporation has announced that it has agreed to buy a Priority Review Voucher (PRV) for $105 million, which it plans to use with an application to get a new drug approved by the U.S. Food and Drug Administration (FDA). The PRV allows United Therapeutics to receive an expedited eight-month review of the new drug application, instead of the standard twelve-month review period.
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United Therapeutics (UTHR) intends to apply the PRV to get approval for Tyvaso DPI, a pulmonary arterial hypertension (PAH) treatment that improves exercise ability in patients.
Tyvaso DPI is an investigational drug-device combination product which, if approved, is expected to provide a more convenient inhalation solution for administering the pulmonary hypertension treatment, compared to traditional nebulized therapies.
“This acquisition affirms our commitment to bring a new generation of treatments to patients with pulmonary hypertension as quickly as possible,” said Michael Benkowitz, President and Chief Operating Officer of United Therapeutics. (See UTHR stock analysis on TipRanks)
Jefferies analyst Eun Yang reiterated her Buy rating on the stock 20 days ago, raising her price target from $155 to $175. This implies upside potential of around 17%. Yang commented that she sees significant opportunity in Tyvaso’s new indication following a physician survey.
Overall, consensus among analysts is a Moderate Buy based on 5 Buys and 1 Sell. The average price target of $173.67 suggests upside potential of around 15% over the next 12 months.
United Therapeutics’ shares have increased in value by 70% so far this year.
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