it's a donut :(
On March 2, 2021, United Therapeutics Corporation (the “Company”) decided to discontinue the development of Trevyent® (treprostinil), due to written comments provided by the U.S. Food and Drug Administration (the “FDA”) on February 25, 2021. The FDA provided these written comments following a meeting between the Company and the FDA to discuss the Company’s planned resubmission of its New Drug Application for Trevyent in light of a Complete Response Letter issued by the FDA in April 2020. The FDA’s comments indicated that the Company would need to both redesign the product to improve pump accuracy in certain respects and conduct a clinical study of the redesigned product. These additional steps would have caused considerable additional delay, and additional development efforts may not ultimately be successful in addressing the FDA’s comments. The Company decided that continued development of Trevyent was no longer commercially reasonable in light of this additional FDA feedback. Moreover, the FDA recently cleared another subcutaneous delivery system, the Remunity® Pump for Remodulin®.
As noted in the Company’s Annual Report on Form 10-K, as of December 31, 2020, the Company’s consolidated balance sheet includes a $107.3 million in-process research and development (“IPR&D”) asset associated with the Company’s August 2018 acquisition of SteadyMed Ltd., the developer of Trevyent. The Company is conducting an impairment analysis for this IPR&D asset and expects to incur an impairment charge during the first quarter of 2021, potentially equal to some or all of the $107.3 million IPR&D asset. The Company plans to disclose the results of this impairment analysis, as well as any additional material financial statement impacts, in its Quarterly Report on Form 10-Q for the quarter ended March 31, 2021.