United Therapeutics Corporation (NASDAQ:UTHR) Files An 8-K Other Events
Item 8.01. Other Events.

On March30, 2018, United Therapeutics Corporation (the “Company”) received notification from the U.S. Food and Drug Administration (“FDA”) that its New Drug Application (“NDA”) for the Implantable System for Remodulin® (“ISR”) has been accepted for a 6-month review as a Class2 Resubmission. The NDA was submitted on January30, 2018, and the Company therefore anticipates FDA action on the NDA by July30, 2018. For additional information regarding the Company’s efforts to develop the ISR, please refer to the Company’s Annual Report on Form10-K for the year ended December31, 2017.

Forward-looking Statements

Statements included in this Current Report on Form8-K that are not historical in nature are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include, among others, statements regarding the regulatory approval process for the ISR. These forward-looking statements are subject to certain risks and uncertainties, such as those described in the Company’s periodic and other reports filed with the Securities and Exchange Commission that could cause actual results to differ materially from anticipated results. Such forward-looking statements are qualified by the cautionary statements, cautionary language and risk factors set forth in the Company’s periodic reports and documents filed with the Securities and Exchange Commission, including the Company’s most recent Annual Report on Form10-K, Quarterly Reports on Form10-Q and Current Reports on Form8-K. The Company claims the protection of the safe harbor contained in the Private Securities Litigation Reform Act of 1995 for forward-looking statements. The Company is providing this information as of March 30, 2018 and assumes no obligation to update or revise the information contained in this Current Report on Form8-K whether as a result of new information, future events or any other reason.

About United Therapeutics Corporation (NASDAQ:UTHR)

United Therapeutics Corporation is a biotechnology company. The Company is focused on the development and commercialization of products for the treatment of chronic and life-threatening conditions. Its therapeutic products and product candidates include Prostacyclin Analogues, Phosphodiesterase Type 5 (PDE-5) Inhibitor and Monoclonal Antibody (MAb). Its Prostacyclin Analogues lead product is Remodulin (treprostinil) Injection. It also includes Tyvaso (treprostinil) Inhalation Solution and Orenitram (treprostinil) Extended-Release Tablets. Its subsidiary is developing another oral prostacyclin analogue for the treatment of pulmonary arterial hypertension (PAH) called esuberaprost. Its PDE-5 inhibitor is Adcirca (tadalafil) tablets are indicated for the treatment of PAH. Its Unituxin (dinutuximab) Injection in combination with granulocyte-macrophage colony-stimulating factor, interleukin-2 and 13-cis-retinoic acid is indicated for the treatment of pediatric patients with neuroblastoma.