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FDA Approves United Therapeutics’ Implantable System for Remodulin

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FDA approval

Today, the FDA approved United Therapeutics’ (UTHR) new drug application for its Implantable System for Remodulin (or ISR).

United Therapeutics developed ISR in collaboration with Medtronic (MDT). In December 2017, the FDA approved Medtronic’s PMA (premarket approval) for its intravascular infusion catheter for use with its SynchroMed II implantable infusion pump and associated infusion system components for administering Remodulin to individuals with pulmonary arterial hypertension. The infusion pump and system components are together known as ISR.

The approval should allow patients a novel option for intravenous administration of Remodulin. The delivery system is implanted into the patient’s body and refilled by healthcare professionals at prescribed intervals.

The approval of the new device could boost the drug’s sales growth. Remodulin is United Therapeutics’ top-selling drug, and it generated revenues of $127.0 million in the first quarter of 2018.

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United Therapeutics’ stock performance

Today, United Therapeutics stock is trading at $124.39, which represents ~3.34% growth from yesterday’s close of $120.26, which represented ~20% growth from its 52-week low of $100.57.

United Therapeutics hit its 52-week high of $152.55 on January 3.

Analysts’ recommendations

Of the 12 analysts tracking United Therapeutics, two recommend a “strong buy” while six analysts recommend a “hold.” Three analysts recommended a “sell” while one analyst recommended a “strong sell.”

United Therapeutics has a consensus 12-month target price of $122.0, which represents a ~1.80% decline over the next 12 months.

Peer ratings

Of the 11 analysts tracking Nektar Therapeutics (NKTR), ~82% recommend a “buy.” Of the 14 analysts tracking Sage Therapeutics (SAGE), all 14 recommend a “buy.”

Nektar Therapeutics and Sage Therapeutics have consensus 12-month target prices of $96.78, and $208.86, respectively, which mean ~85.22% and ~43.43% returns on investment over the next 12 months.

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