RemoSync Regulatory Delay Raises Concern and Risk for United’s Treprostinil Franchise
The anticipated launch of United and Medtronic’s implantable Remodulin device RemoSync—which was expected this year—has been postponed to likely the first half of 2018. Pushing RemoSync’s launch back to 2018 doesn’t materially affect our fair value estimate. However, this marks the drug/device combo’s second regulatory delay after a complete response letter from the U.S. Food and Drug Administration in 2015. We acknowledge the complexities of an implantable device for a dose-sensitive drug like ...United Therapeutics is a biotechnology company. The company markets and sells four commercial therapies to treat pulmonary arterial hypertension (PAH): Remodulin? (treprostinil) Injection; Tyvaso? (treprostinil) Inhalation Solution; Orenitram? (treprostinil) Extended-Release Tablets; and Adcirca? (tadalafil) Tablets. The company also markets and sells an oncology product, Unituxin? (dinutuximab) Injection for treatment of high-risk neuroblastoma. The company also engages in research and development of new indications and formulations and delivery devices for its existing products, as well as new products to treat PAH and other conditions. The company also engages in organ transplantation-related technologies.
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